Regulatory Notes

HEADS UP - February 25, 2013

Notices of Compliance - February 18 – 22, 2013

• There were no new NOCs published this week.

News from Health Canada…

Health Canada

Announcement: The Honourable Leona Aglukkaq, Minister of Health, along with David Wilkes, Sr. Vice President, Grocery Division, from the Retail Council of Canada, launched the latest phase of the Harper Government's national Eat Well campaign which promotes healthy eating and healthy weights.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2013/2013-30-eng.php

Natural Health Products Directorate (NHPD)

Report: NHPD Quarterly Report for the period of October 1, 2012 to December 31, 2012 (Quarter 3 of the 2012-2013 fiscal year).
(See attached).
  www.jptcp.com/files/2012_2013_Q3_Report_Cover_Letter.pdf www.jptcp.com/files/Quarterly%20Report%2012_13,%20Q3_%20FR[1].pdf
 

Therapeutic Products Directorate (TPD)

Health Care Professional Advisory

Samsca: Otsuka Canada Pharmaceutical Inc. (Otsuka) in consultation with Health Canada would like to inform you of a risk of liver injury associated with the use of Samsca (tolvaptan).
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/23671a-eng.php

Consumer Health Advisory

Samsca: Otsuka Canada Pharmaceutical Inc. (Otsuka), in association with Health Canada, would like to inform you of important new safety information related to the potential risk of serious liver damage associated with the use of Samsca (tolvaptan). Three (3) cases of liver damage were reported during clinical trials to study tolvaptan for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD).
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/23679a-eng.php

Record of Decisions: A Record of Decisions is available for the May 14, 2012 meeting between Health Canada and the Direct Sellers Association (DSA).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/assoc/2012-05-14-eng.php

Record of Decisions: A Record of Decisions is available for the May 16, 2012 meeting between Health Canada and the Canadian Consumer Specialty Products Association (CCSPA).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/assoc/2012-05-16-eng.php

Record of Decisions: A Record of Decisions is available for the May 23, 2012 meeting between Health Canada and Canada’s Research-Based Pharmaceutical Companies (Rx&D).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/assoc/2012-05-23-eng.php

Record of Decisions: A Record of Decisions is available for the June 6, 2012 meeting between Health Canada and Canada's Medical Device Technology Companies (MEDEC).
http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/meet-reunion/2012-06-06-eng.php

Record of Decisions: A Record of Decisions is available for the June 27, 2012 meeting between Health Canada and the Groupement provincial de l'industrie du médicament (GPIM).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/assoc/2012-06-27-eng.php

Guidance Document: Health Canada is pleased to announce the release of the Guidance Document: Factors Influencing the Classification of Products at the Device-Drug Interface.
http://www.hc-sc.gc.ca/dhp-mps/dev-drug-instr-drogue/class_prod_gd_ld-eng.php

Classification: A Classification of Health Products at the Device-Drug Interface is available.
http://www.hc-sc.gc.ca/dhp-mps/dev-drug-instr-drogue/index-eng.php

National Interest

Gazette I

Department of Health Act: A Notice of annual increase of Health Canada’s Drug Master Files and Certificate of a Pharmaceutical Product fees is available.
http://www.gazette.gc.ca/rp-pr/p1/2013/2013-03-02/html/notice-avis-eng.html#d101

Financial Administration Act: A Notice of annual increase of Fees in Respect of Drugs and Medical Devices Regulations.
http://www.gazette.gc.ca/rp-pr/p1/2013/2013-03-02/html/notice-avis-eng.html#d102

Canadian Intellectual Property Office (CIPO)

Report: The 2011-12 Annual Report on the Patent Prosecution Highway Program is now available.
http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr03625.html
 

 

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Notices of Compliance - February 4 – 8, 2013

• There were no new NOCs published this week.

News from Health Canada…

Health Canada

Health Advisory: A Toronto retail outlet (Handy Variety, 591 Sherbourne St.) has voluntarily handed over counterfeit Viagra and Cialis to Health Canada following a compliance and enforcement action by the Department.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/23209a-eng.php

HPFB Inspectorate

Consultation: An invitation participate in a “Survey for ICH Q7 Constituencies: Input for Development of a Q&A Document” is available.
http://www.hc-sc.gc.ca/dhp-mps/consultation/compli-conform/2013-ich-q7-eng.php

Therapeutic Products Directorate (TPD)

Draft Revised Guidance Document: A Draft Revised Guidance Document - Review of Drug Names for Look-alike Sound-alike (LASA) Attributes is available.
http://www.hc-sc.gc.ca/dhp-mps/consultation/medeff/_2013/lasa-pspcs/index-eng.php

Register of Innovative Drugs: The Register of Innovative Drugs is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

National Interest

Canadian Intellectual Property Office (CIPO)

Meeting: The Canadian Intellectual Property Office (CIPO) is conducting roundtable sessions with Canadian small and medium-sized enterprises (SMEs — companies with less than 500 employees) that have filed at least one patent and/or trade-mark application in Canada.
http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr03521.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Consultation: A draft Issues in Emerging Health Technologies bulletin on anacetrapib for the treatment of dyslipidemia is available for feedback from all interested stakeholders.
http://www.cadth.ca/en/products/environmental-scanning/issues-in-emerging-health-technologies/call-for-feedback?utm_source=Anacetrapib-feedback&utm_medium=webmail&utm_campaign=e-alert-02-13-13
 

 

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Notices of Compliance - January 28 – February 1, 2013

• Picato (ingenol mebutate) was approved as a chemotherapeutic for topical use on January 30, 2013.
• Adcetris (brentuximab vedotin) was approved as an antineoplastic agent on February 1, 2013.

News from Health Canada…

Health Canada

Announcement: Today, the Honourable Leona Aglukkaq, Minister of Health, announced Health Canada published a revised research design for the wind turbine noise and health study, which is being carried out in collaboration with Statistics Canada.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2013/2013-021-eng.php

Information Update: Health Canada today suspended all medical device licences issued to and associated with IND Diagnostic of Delta, B.C., under its powers in the Food and Drugs Act, because of concerns about the company’s management systems and distribution practices.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/23151a-eng.php

HPFB Inspectorate

Notice: Good Pharmacovigilance Practices (GVP) is the new name for the Post-Market Reporting Compliance (PMRC) inspection program.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/docs/notice-avis_gvp-eng.php

Guidelines: Good Pharmacovigilance Practices (GVP) Guidelines (GUI-0102) is available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/docs/gui-0102_gvp-eng.php

Document: The Risk Classification of Good Pharmacovigilance Practices (GVP) Observations (GUI-0063) is available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/docs/gui-0063_gvp-eng.php

Document: The Inspection Strategy for Good Pharmacovigilance Practices (GVP) for Drugs (POL-0041) is available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/docs/pol-0041_gvp-eng.php

Biologics and Genetic Therapies Directorate (BGTD)

Consultation: Health Canada announces the release of the draft Guidance document Submission and Information Requirements for Extraordinary Use New Drugs (EUNDs) for a 75-day consultation from February 12th, 2013 to April 29th, 2013 inclusive.
http://www.hc-sc.gc.ca/dhp-mps/consultation/biolog/eunds-dnue-eng.php

(Draft Guidance & Form - see attached) www.jptcp.com/files/DraftEUNDGuidance_NtoS_EN.pdf www.jptcp.com/files/DraftEUNDGuidance_NtoS_FR.pdf

Natural Health Products Directorate (NHPD)

Meeting: Information is available on the meeting held on December 3, 2012 with the Canadian Association of Naturopathic Doctors (CAND).
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/activit/bilat/rod-cr_12-03-12-eng.php

Notice: On September 30, 2010, Health Canada issued a Position Statement on the preclearance and complaint adjudication of exempted natural health product (NHP) Advertising Materials. As planned, the NHP-UPLAR ended on February 4, 2013. This means that no new exemption numbers will be issued for NHPs.
(See attached) www.jptcp.com/files/Repeal_of_NHP_UPLAR_e.pdf

Therapeutic Products Directorate (TPD)

Consultation: The proposed amendments to the Food and Drug Regulations regarding the repeal of Schedule F and the Creation of a Prescription Drug List are available for comment for a period of 75 days.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/pdl_consult_ldo-eng.php

Notice: Health Canada is pleased announce an extension of the deadline for using the old Canadian Module 1 DTD Version 1.0 to build electronic Common Technical Document (eCTD) regulatory activities.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ctd/ectd/ectd_schema_ext_pro-eng.php

Summary Basis of Decision: A Summary Basis of Decision is available for Stribild.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2013_stribild_152198-eng.php

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

Consultation: A draft Issues in Emerging Health Technologies bulletin on point-of-care phenotypic and genetic testing for patients with acute coronary syndrome is available for feedback from all interested stakeholders.
http://cadth.ca/en/media-centre/e-alert/e-alert-02-11-13

Patented Medicine Prices Review Board (PMPRB)

The Evaluation of the Patented Medicine Prices Review Board and the corresponding Management Response to the 2011-12 PMPRB Program Evaluation are now available on the website.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=317
 

HEADS UP - January 28, 2013

Notices of Compliance - January 21 – January 25, 2013

• There were no new NOCs published this week.

News from Health Canada…

Health Canada

Announcement: Canadians now have access to more than 60,000 licensed natural health products as a result of the Government of Canada’s more efficient approach to authorizing these products, Parliamentary Secretary of Health, Dr. Colin Carrie announced today. 
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2013/2013-18-eng.php

Information Update: Health Canada is advising Canadians that Novartis Consumer Health Canada Inc. is conducting a voluntary recall of 17 products as the child resistant mechanism of the bottle cap can fail.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2013/2013_16-eng.php

Information Update: Health Canada is currently conducting a review of all available safety information on the drug Diane-35. Health Canada has been monitoring the safety of Diane-35 on an ongoing basis, as it does for all drugs on the market. The Department is aware of the decision by France to suspend the marketing authorization of Diane-35 within the next three months.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2013/2013_17-eng.php

Natural Health Products Directorate (NHPD)

Regulations: Questions and answers regarding the end of the Natural Health Products (Unprocessed Product Licence Applications) Regulations – NHP-UPLAR are available.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/faq/uplar-dlmmnt-eng.php

Therapeutic Products Directorate (TPD)

Draft Guidance: The Draft (Step 2) International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance: ICH S10 - Photosafety Evaluation of Pharmaceuticals is available.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult_s10_step2_etape2-eng.php

Notice: A Regulatory Notice for Public Input is available regarding the International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) S1: Proposed Change to Rodent Carcinogenicity Testing of Pharmaceuticals.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult_s1_notice_avis-eng.php

Drug and Medical Device Recall Listings: The Drug and Medical Device Recall Listings have been updated.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/index-eng.php

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

National Interest

Canadian Intellectual Property Office (CIPO)

Deposit Accounts: As of February 1, 2013, CIPO's deposit account holders are able to replenish their accounts via their Canadian bank’s online banking system.
http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr03621.html
 

 

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font color='336666'HEADS UP- January 21, 2013

Notices of Compliance - January 14 – January 18, 2013

• There were no new NOCs published this week.

News from Health Canada…

Health Canada

Announcement: The Honourable Leona Aglukkaq, Minister of Health, today congratulated Accreditation Canada on including, for the first time, guidance on the reporting of adverse drug reactions in its latest Medication Management Standards for health care facilities, including hospitals.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2013/2013-01-eng.php

Information Update: Arbonne International Distribution Inc. is voluntarily recalling one lot (lot 043904) of its RE9 Advanced for Men Facial Moisturizer SPF 20 Sunscreen due to microbial contamination.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2013/2013_15-eng.php

Information Update: Health Canada is informing Canadians of a labelling update for all cholesterol-lowering drugs (also known as statins) regarding the risk of increased blood sugar levels and a small increased risk of diabetes among patients already at risk for the disease.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2013/2013_11-eng.php

Information Update: Health Canada is informing Canadians that Prestige Brands is conducting a voluntary recall of one lot (lot 3742) of its Infants’ Little Remedies for Fevers after testing conducted by the company indicated some bottles may contain less than the claimed amount of acetaminophen.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2013/2013_12-eng.php

Natural Health Products Directorate (NHPD)

Calendar: The Natural Health Products Directorate (NHPD) six-month calendar of activities: January 1 to June 30, 2013 is available.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/activit/calend/06-2013-eng.php

Consultation: The Natural Health Products Directorate (NHPD) is seeking feedback on two newly proposed monographs and three revised monograph for ingredients.
http://www.hc-sc.gc.ca/dhp-mps/consultation/natur/pre-cleared_information_preautorisee-290113-eng.php

Therapeutic Products Directorate (TPD)

Record of Proceedings: A Record of Proceedings is available for the Therapeutic Products Directorate Scientific Advisory Committee on Respiratory and Allergy Therapies (SAC-RAT) meeting that was held on October 26, 2012.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-com/resp_allerg/sacrat_rop_ccstrta_crd_2012-10-26-eng.php

National Interest

Canadian Intellectual Property Office (CIPO)

Agreement: On January 31, 2013, CIPO will commence a PCT-PPH pilot agreement with the United States Patent and Trademark Office (USPTO), to run for a period of two years, ending January 30, 2015.Additionally, the PCT-PPH pilot project based on international work products established by CIPO as the International Searching Authority (ISA) and/or the International Preliminary Examining Authority (IPEA) is being continued indeterminately.
http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr03620.html

Seminar: The Patent Branch would like to invite clients, scientists and inventors to present the technical aspects of their field of expertise to Patent Examiners.
http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr03603.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Consultation: A draft “Issues in Emerging Health Technologies” bulletin on catheter-based renal denervation for treatment-resistant hypertension is available for feedback.
http://www.cadth.ca/en/products/environmental-scanning/issues-in-emerging-health-technologies/call-for-feedback3?utm_source=Renal-Denervation-feedback&utm_medium=webmail&utm_campaign=e-alert-01-30-13

Consultation: The draft recommendations report for the optimal use project on High-Sensitivity Cardiac Troponin for the Rapid Diagnosis of Acute Coronary Syndrome in the Emergency Department is available for input.
http://www.cadth.ca/en/products/optimal-use/high-sensitivity-troponin/feedback?utm_source=Troponin-feedback&utm_medium=webmail&utm_campaign=e-alert-01-30-13

Consultation: CADTH is pleased to invite all interested parties to provide feedback on the draft report on transcatheter aortic valve replacement.
http://www.cadth.ca/en/products/rapid-response/tavr-feedback?utm_source=tavr-feedback&utm_medium=webmail&utm_campaign=e-alert-01-28-13

Pharmaceutical Advertising Advisory Board (PAAB)

Webinars: The PAAB will be hosting a series of webinar events during the first week of March. You will have the opportunity to ask questions, directed to PAAB staff, about the PAAB Code revisions coming into effect July 1, 2013 and the recently released guidance documents posted on the PAAB web-site.
http://www.paab.ca/events/
 

 

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HEADS UP - January 7, 2013

Notices of Compliance- December 31, 2012 – January 4, 2013

• There were no new NOCs published this week.

News from Health Canada…

HPFB Inspectorate

Report: The Summary Report: Stakeholder Consultation Workbook for the Medical Devices Inspection Cycle is available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/info-prod/md-im/md-im-consultation-summary-sommaire-eng.php

Policy: The Health Products and Food Branch Inspectorate have released a Policy for the Inspection of Medical Device Companies.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/info-prod/md-im/pol-0035_insp_strat_doc-eng.php

Guidance: A Guidance Document on the Medical Device Inspection Program (GUI-0064) is now available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/info-prod/md-im/md_insp_prog-prog_insp_mm-eng.php

Biologics and Genetic Therapies Directorate (BGTD)

Record of Decisions: A Record of Decisions is available for the November 13, 2012 meeting of the BIOTECanada Vaccine Industry Committee (VIC) and the Biologics and Genetic Therapies Directorate (BGTD).
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/activit/meet-reunion/vic-civ-mm-crr-2012-11-13-eng.php

Notice: The second edition of the Canadian Standard Association (CSA) Z900 Package of Standards - Cells, Tissues, and Organs for Transplantation has been released.
(See attached) www.jptcp.com/files/BGTD_Notice.pdf

Therapeutic Products Directorate (TPD)

Notice: Health Canada is pleased to announce the launch of the first pilot initiative of the RCC Common Monograph Elements Working Group. The working group has selected as its first area of alignment common cold indications for certain over-the-counter antihistamine ingredients.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/announce-annonce/rcc_notice_ccr_avis-eng.php

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

Report: A Summary Report of Inspections of Cells, Tissues and Organs Establishments Conducted from August 2009 to June 2012 is available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/info-prod/cell/report-rapport_2009-2012_CTO-eng.php

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

Consultation: For the therapeutic review “Antithrombotic Therapy for Patients with Atrial Fibrillation”, draft recommendations and a second draft of the science report will be available for feedback later this month.
http://cadth.ca/en/media-centre/e-alert/e-alert-01-08-13

Consultation: Updated systematic reviews and cost-effectiveness analyses of second- and third-line pharmacotherapies for type 2 diabetes are now available for input from all interested stakeholders.
http://www.cadth.ca/en/media-centre/e-alert/e-alert-01-10-13

Pharmaceutical Advertising Advisory Board (PAAB)

Newsletter: The January 2013 issue of the PAAB Views is available.
http://www.paab.ca/resources/newsletters/PAAB_Views_January_2013_E.pdf
 

 

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HEADS UP - December 31, 2012

Notices of Compliance - December 24 – December 28, 2012

• There were no new NOCs published this week.

News from Health Canada…

Health Canada

Information Update: Health Canada has released an important reminder about weight-loss health products.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2013/2013_02-eng.php

Therapeutic Products Directorate (TPD)

Notice: An updated screening criteria for generic pharmaceutical pre-market submissions to replace the Integrated Review Process (pre-evaluation) has been announced.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/form/int_drug_list_notice_avis_proc_int_exam-eng.php

Checklist: A Sponsor Attestation Checklist for Abbreviated New Drug Submissions (ANDS) and Supplements to an Abbreviated New Drug Submission (SANDS) is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/form/int_drug_list_form_proc_int_exam-eng.php

Summary Basis of Decision: A Summary Basis of Decision for Removab is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2012_removab_142629-eng.php

Summary Basis of Decision: A Summary Basis of Decision for Potiga is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2012_potiga_134659-eng.php

Summary Basis of Decision: A Summary Basis of Decision for Kalydeco is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2012_kalydeco_155318-eng.php

Drug and Medical Device Recall Listings: The Drug and Medical Device Recall Listings have been updated.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/index-eng.php

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

Newsletter: The Canadian Adverse Reaction Newsletter, Volume 23 - Issue 1 - January 2013.
http://www.hc-sc.gc.ca/dhp-mps/medeff/bulletin/carn-bcei_v23n1-eng.php

National Interest

Gazette I

Controlled Drugs and Substances Act: An erratum regarding the Notice to interested parties — Proposed improvements to the Marihuana Medical Access Program (MMAP) — Research and development activities is available.
http://www.gazette.gc.ca/rp-pr/p1/2013/2013-01-05/html/notice-avis-eng.html#d105

Canadian Intellectual Property Office (CIPO)

Deposit Account Replenishment: Changes in the deposit account replenishment process have been made.
http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr03616.html

PCT national phase applications: CIPO wishes to clarify its position with respect to the practice of amending PCT national phase patent applications.
http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr03615.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The newsletter, New at CADTH – December 2012 is available.
http://www.cadth.ca/en/media-centre/new-at-cadth/new-at-cadth-dec2012

Pharmaceutical Advertising Advisory Board (PAAB)

Request for Proposal: The Pharmaceutical Advertising Advisory Board invites suppliers to submit proposals for the development and support of a replacement submission and document management system in accordance with the requirements, terms, and conditions of this Request for Proposal (RFP).
http://www.paab.ca/resources/pdfs/12%2021%202012%20PAAB%20RFB%20Submission%20and%20Document%20Management%20System.pdf

 

 

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HEADS UP - December 24, 2012

Notices of Compliance - December 10 – December 21, 2012

• Bystolic (nebivolol HCL) was approved as an Antihypertensive Agent on 2012-12-21.

• Diacomit (stiripentol) was approved as an Antiepileptic on 2012-12-21.

News from Health Canada…

Health Canada

Consultation: Consultation on the new Prescription Drug List.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/pdl_consult_ldo-eng.php

Health Advisory: Four unauthorized natural health products have been removed from sale as they may pose serious risks to the health of Canadians. The “ExtenZe” products are promoted as sexual enhancement products and contain ingredients that legally require they be sold with a prescription in Canada.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2013/2013_01-eng.php

Natural Health Products Directorate (NHPD)

Guidance Document: The guidance document “Pathway for Licensing Natural Health Products Making Modern Health Claims” is available.
http://www.hc-sc.gc.ca/dhp-ps/alt_formats/pdf/prodnatur/legislation/docs/modern-eng.pdf

Guidance Document: The guidance document “Pathway for Licensing Natural Health Products used as Traditional Medicines” is available.
http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/prodnatur/legislation/docs/tradit-eng.pdf

Therapeutic Products Directorate (TPD)

Draft Guidance Document: The draft guidance document “Determining Prescription Status for Human and Veterinary Drugs” has been released.
http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/consultation/drug-medic/pdl_gd_draft_ord_ld_ebauche-eng.pdf

Drug and Medical Device Recall Listings:  The Drug and Medical Device Recall Listings have been updated.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/index-eng.php

National Interest

Patented Medicine Prices Review Board (PMPRB)

Appointment: Richard Bogoroch appointed to the Patented Medicines Prices Review Board.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=314
 

 

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HEADS UP - December 10, 2012

Notices of Compliance - December 3 – December 7, 2012

• There were no new NOCs published during this week.

News from Health Canada…

Health Canada

Announcement: Today the Honourable Leona Aglukkaq, Minister of Health, and the Honourable Jim Flaherty, Minister of Finance, are pleased to congratulate the Chagnon Family and the Azrieli Foundation for partnering with Brain Canada and the Government of Canada, through the Canada Brain Research Fund, by making major donations to support neuroscience research.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2012/2012-201-eng.php

Health Advisory: Health Canada's testing of "EV Princess Express Peeling", "EV Princess Extra Whitening Night Cream" and "Ling Zhi BB Whitening Cream" identified levels of mercury that are beyond the allowable limit set by Health Canada.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_202-eng.php

Foreign Product Alerts: The following Foreign Product Alerts have been issued:

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2012/2012-198-eng.php
(Reumofan Plus - Reumofan Plus Premium)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2012/2012-199-eng.php
(iFlora Kids Multi-Probiotic - florAlign PREBIOTIC FORMULA - Wellesse Digestive 3-in-1 Health)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2012/2012-200-eng.php
(Tianji True Slim; Ultimate Formula Bee Pollen Capsules; Zi Xiu Tang Bee Pollen Capsules; Beautiful Slim Body; Best Share Green Coffee: Brazilian Slimming Coffee; Japan Hokkaido Slimming Weight Loss Pills)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2012/2012-201-eng.php
(Z-Rock All Natural Male Supplement - Sachets de poudre Extra Power - Comprimés Rock Hard for Men - Comprimés Ultra Men for Men - Gélules MMC Maxman IV Erection Enhancer - Spider Sex - Toha - Dong Qing San Bian Li)

Information Update: Further to previous communications, Health Canada is advising Canadians that three additional unauthorized products promoted for weight loss have been seized from the “Cube Inc.” store in Richmond, B.C.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_197-eng.php

Therapeutic Products Directorate (TPD)

            Health Care Professional Advisory

Pradaxa/Pradax: Boehringer Ingelheim (Canada) Ltd. (BICL), in consultation with Health Canada (HC), would like to inform you about important new safety information relating to the use of PradaxaTM (dabigatran etexilate), also known as Pradax®, in patients with prosthetic heart valves.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2012/pradaxa_hpc-cps-eng.php

Notice: A Notice has been issued regarding the Pilot project for the Implementation of the Development Safety Update Report Regulatory Review at Health Canada.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ich/efficac/e2f_dsur_pilot-eng.php

Report: A Summary report of the Drug Good Manufacturing Practices (GMP) Inspection Program - April 1, 2006 to March 31, 2011 is available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/2011-03-31-report-rapport-eng.php

Drug Establishment Licensing: A number of documents regarding Drug Establishment Licensing are available:

http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/ren-doc/del-lepp-faq-eng.php
(Frequently Asked Questions - Drug Establishment Licensing and Fees)

http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/directives/gui-0002-eng.php
(Guidance on Drug Establishment Licences and Drug Establishment Licensing Fees (GUI-0002))

Drug and Medical Device Recall Listings: The Drug and Medical Device Recall Listings have been updated.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/index-eng.php

Summary Basis of Decision: A Summary Basis of Decision for Treanda is now available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2012_treanda_149814-eng.php

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

National Interest

Gazette I

Financial Administration Act: Regulations amending the fees in respect of drugs and medical devices regulations are available.
http://www.gazette.gc.ca/rp-pr/p1/2012/2012-12-22/html/reg3-eng.html

Food and Drug Regulations: Regulations amending certain regulations concerning prescription drugs (repeal of Schedule F to the Food and Drug Regulations).
http://www.gazette.gc.ca/rp-pr/p1/2012/2012-12-22/html/reg2-eng.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Consultation: The Canadian Agency for Drugs and Technologies in Health (CADTH) is pleased to invite all interested stakeholders to provide feedback on the list of included studies being considered for the review of drug therapies for relapsing-remitting multiple sclerosis (RRMS).
http://www.cadth.ca/en/products/therapeutic-reviews/relapsing-remit-multiple-sclerosis/call-for-feedback?utm_source=TR-MS-Call-for-feedback&utm_medium=webmail&utm_campaign=e-alert-12-20-12

Report: Environmental Scans -Issue 38 - Cardiac Troponin Assays for the Diagnosis of Acute Coronary Syndrome is available.
http://www.cadth.ca/en/products/environmental-scanning/environmental-scans/environmental-scan-38

Patented Medicine Prices Review Board (PMPRB)

Voluntary Compliance Undertaking: The Chairperson of the Board accepted a Voluntary Compliance Undertaking (VCU) for Halaven.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=311

Voluntary Compliance Undertaking: The Chairperson of the Board accepted a Voluntary Compliance Undertaking (VCU) for Procytox, Uromitexan, and Ifex.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=312

Meeting: The PMPRB 101 session for Patentees was held in Ottawa in December 2012.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=1511&id=313

National Association of Pharmacy Regulatory Authorities (NAPRA)

Newsletter: The most recent edition of NAPRA Notes is now available.
http://napra.ca/Content_Files/Files/NAPRA_Notes_Fall-Winter_2012.pdf
 

 

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HEADS UP - November 26, 2012

Notices of Compliance - November 19 – November 23, 2012

• There were no new NOCs published during this week.

News from Health Canada…

Health Canada

Health Advisory: Three unauthorized health products -- "Man Up Now", "Black Ant", "Triple Power Zen Gold 1200mg"-- are being recalled by DVDXPRO after testing by Health Canada identified undeclared ingredients that may pose serious risks to the health of Canadians.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_181-eng.php

Information Update: Health Canada is advising Canadians that three unauthorized products promoted for weight loss have been seized from “Cube Inc.”, a box-store in Richmond, B.C.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_180-eng.php

Information Update: Health Canada has suspended the Establishment Licence of Chemi Pharmaceutical Inc. of Mississauga, Ont., after uncovering falsified testing results during the course of an inspection.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_184-eng.php

Information Update: On December 3, 2012, Health Canada suspended the Establishment Licence of Mississauga, Ontario-based testing facility Chemi Pharmaceutical Inc. after finding falsified test results during an inspection.
As a precautionary step, companies that have had testing done by Chemi Pharmaceutical are being asked to temporarily halt sales of those products until their safety can be confirmed.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_184lt-eng.php

Natural Health Products Directorate (NHPD)

Report: The NHPD Quarterly Report for the period of July 1, 2012 to September 30, 2012 (Quarter 2 of the 2012-2013 fiscal year) is available.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/report-rapport/qar_tri_2-13-eng.php

Consultation: The Natural Health Products Directorate (NHPD) is seeking your feedback on eleven newly proposed monographs and three revised monograph for ingredients.
http://www.hc-sc.gc.ca/dhp-mps/consultation/natur/pre-cleared_information_preautorisee-041212-eng.php

Therapeutic Products Directorate (TPD)

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

Consultation: A draft report on the High-Sensitivity Cardiac Troponin for the Rapid Diagnosis of Acute Coronary Syndrome in the Emergency Department optimal use project is available for feedback.
http://www.cadth.ca/en/products/optimal-use/high-sensitivity-troponin/reports?utm_source=cardiac-troponin&utm_medium=eblast1&utm_campaign=e-alert-11-30-12

Consultation: The Canadian Agency for Drugs and Technologies in Health (CADTH) is pleased to invite all interested parties to provide feedback on the list of included studies being considered for the update to the systematic review of clinical and cost-effectiveness of pharmacotherapy for type 2 diabetes.
http://www.cadth.ca/en/products/optimal-use/second-line-therapies/call-for-feedback?utm_source=diabetes-update&utm_medium=eblast1&utm_campaign=e-alert-12-03-12
 

 

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HEADS UP - November 19, 2012

Notices of Compliance - November 12 – November 16, 2012

• There were no new NOCs published during this week.

News from Health Canada…

Health Canada

Health Advisory: Energizer Personal Care has expanded its recall of continuous spray sun care products in Canada because there is a possibility that these sunscreens could ignite on the skin if the consumer comes into contact with an open flame or spark before the spray has completely dried.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_175-eng.php

Information Update: Health Canada is advising Canadians and health care practitioners that no thermography (thermal imaging) machines have been approved to screen for breast cancer in Canada.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_178-eng.php

Natural Health Products Directorate (NHPD)

Notice: The NHPD has issued a Notice to Stakeholders on Nattokinase.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/nattokinase-eng.php

Notice: A notice regarding the transition of adverse reaction reporting related to natural health product clinical trials is available.
(See attached) www.jptcp.com/files/NHPD_Stakeholder.28_November_2012.pdf

Therapeutic Products Directorate (TPD)

Meeting: A Record of Decisions is available for the September 25, 2012 bilateral meeting of the Nuclear Medicine Alliance (NMA) and the Biologic and Genetic Therapies Directorate (BGTD).
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/activit/meet-reunion/nma-mm-crr-2012-09-25-eng.php

Drug and Medical Device Recall Listings: The Drug and Medical Device Recall Listings have been updated.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/index-eng.php

Notice of Decision: A Notice of Decision has been issued for Oxyneo.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/nd_ad_2012_oxyneo_141379-eng.php

List: A List of Registrars Recognized by Health Canada under section 32.1 of the Medical Devices Regulations (MDR) is available.
http://www.hc-sc.gc.ca/dhp-mps/md-im/qualsys/list_liste_regist-eng.php

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

Reports: To assist health care providers, policy-makers, and consumers in making well-informed decisions about second- and third-line therapy for patients with inadequately controlled diabetes, CADTH completed research and resulting recommendations which are now are available in a series of Optimal Therapy Reports.
http://www.cadth.ca/en/products/optimal-use/second-line-therapies/reports

Pharmaceutical Advertising Advisory Board (PAAB)

Code Book: The new PAAB Code Book is now available.
http://www.paab.ca/resources/pdfs/PAAB%20Code%20Eng%20Nov%2023%202012.pdf

Code Book: The new PAAB Code Book with changes highlighted is now available.
http://www.paab.ca/resources/pdfs/PAAB%20Code%20Eng%20Nov%2023%202012_changes_highlighted.pdf
 

 

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Notices of Compliance - November 5 – November 9, 2012

• There were no new NOCs published during this week.

News from Health Canada…

Health Canada

Announcement: Minister Aglukkaq announces new rules to address prescription drug abuse.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2012/2012-174-eng.php

Natural Health Products Directorate (NHPD)

Consultation: The Health Products and Food Branch (HPFB) is seeking your feedback on proposed changes to the existing guidance document - Sunburn Protectants (October 12, 2006).
http://www.hc-sc.gc.ca/dhp-mps/consultation/natur/consult_sunscreen-ecransolaire-eng.php

Therapeutic Products Directorate (TPD)

Health Care Professional Advisory

Prolia: Amgen Canada Inc., in consultation with Health Canada, would like to inform healthcare providers of new important safety information regarding the risk of atypical femoral fractures associated with PROLIA treatment.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2012/prolia_hpc-cps-eng.php

Document: The document entitled, “Inspection Strategy for Cells, Tissues and Organs Establishments” (POL-0057) is available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/info-prod/cell/pol-0057_doc-eng.php

Report: The Summary Report: Stakeholder Consultation Workbook for the Cells, Tissues and Organs Programs Inspection Strategy is available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/info-prod/cell/report-rapport_CTO-eng.php

Summary Basis of Decision: A Summary Basis of Decision is available for Jakavi.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2012_jakavi_151723-eng.php

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The newsletter, CDR Update – Issue 83 is available.
http://www.cadth.ca/en/products/cdr/cdr-update/cdr-update-83
 

 

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HEADS UP - November 5, 2012

Notices of Compliance - October 29 – November 2, 2012

• There were no new NOCs published during this week.

News from Health Canada…

Health Canada

Announcement: The Honourable Leona Aglukkaq, Minister of Health, today announced that Canada's Food and Drug Regulations will become even stronger.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2012/2012-169-eng.php

Biologics, Radiopharmaceuticals & Genetic Therapies Directorate (BGTD)

Report: The Biologics and Genetic Therapies Directorate Drug Submission Performance Quarterly Report; July – September 2012 is available.
(See attached) www.jptcp.com/files/bgtd_dpbtg_12_jul_sep_eng.pdf

Therapeutic Products Directorate (TPD)

Health Care Professional Advisory

Agriflu and Fluad: Novartis Pharmaceuticals Canada Inc. ("Novartis"), in collaboration with Health Canada would like to inform you that the review of safety information for AGRIFLU® and FLUAD® is now complete and Health Canada has released the two seasonal flu vaccines for immediate use.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2012/agriflu_fluad_hpc-cps-eng.php

Zocor: Merck Canada Inc., in consultation with Health Canada, would like to inform you of important safety recommendations on dosage related to the increased risk of myopathy/rhabdomyolysis, particularly with the 80 mg dose of ZOCOR® (simvastatin; also marketed as generics).
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2012/zocor_hpc-cps-eng.php

Drug and Medical Device Recall Listings: The Drug and Medical Device Recall Listings have been updated.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/index-eng.php

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

Notice: Health Canada is pleased to announce the release of the Guidance Document ‘Regulatory Framework for Unauthorized New Allergenic Products of Biological Origin used for the Diagnosis or Treatment of Allergic Diseases’.
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/applic-demande/guides/allergenic_allergenes_2012-eng.php

Guidance: Annex 14 to the Current Edition of the Good Manufacturing Practices Guidelines - Schedule D Drugs, Human Blood and Blood Components (GUI-0032) is available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/info-prod/don/gui-0032-eng.php

Report: The Therapeutic Products Directorate Drug Submission Performance Quarterly Report; July – September 2012 is available.
(See attached) www.jptcp.com/files/tpd_dpt_12_jul_sep_eng.pdf

Summary Basis of Decision: A Summary Basis of Decision is available for Arzerra.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2012_arzerra_128188-eng.php

Summary Basis of Decision: A Summary Basis of Decision is available for Inlyta.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2012_inlyta_144404-eng.php

National Interest

Canadian Intellectual Property Office (CIPO)

Notice: Change to hours in CIPO's designated establishment in Ottawa, effective January 2, 2013.
http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr03571.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Report: A draft Environmental Scan report on the topic of Transcatheter Aortic Valve Replacement is available for feedback from all interested stakeholders.
http://www.cadth.ca/en/products/e-alert/e-alert-2012-11-12
 

HEADS UP - October 22, 2012

Notices of Compliance - October 15 - 19, 2012

• Potiga (ezogabine) was approved as an Antiepileptic Agent on 2012-10-18.

News from Health Canada

Health Canada

Information Update: The natural health product "Pollen Allergy" (NPN 80035736), now sold as "Tongqiao Biyan Pian," is being recalled from the Canadian market after testing conducted by Health Canada identified levels of arsenic that exceed Departmental allowable limits.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_160-eng.php

Information Update: Health Canada would like to provide further information to Canadians about its assessment of the voluntary suspension of use in Europe of the seasonal flu vaccines Agriflu and Fluad that are produced by Novartis.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_162-eng.php

Information Update: As the U.S. Food and Drug Administration (FDA) continues to expand its warnings about products made at the New England Compounding Center (NECC), Health Canada would like to advise Canadians that, to date, there have been no Canadian cases reported to Health Canada of fungal meningitis linked to contaminated health products from the NECC.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_163-eng.php

Information Update: Health Canada has completed its review of safety information for Agriflu and Fluad and is releasing the two seasonal flu vaccines for immediate use.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_164-eng.php

Therapeutic Products Directorate (TPD)

Notice to Hospitals

Carboplatin injection: Hospira Healthcare Corporation, in consultation with Health Canada, would like to inform you that a recall has been initiated of one lot of Carboplatin injection distributed in Canada due to visible crystal like particulate matter observed during an inspection of retained samples.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2012/carboplatin_nth-aah-eng.php

Summary Basis of Decision: A Summary Basis of Decision is available for Tretten.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2012_tretten_152228-eng.php

Agenda: An agenda for the Scientific Advisory Committee on Nonprescription Drugs meeting on November 16, 2012 is now available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-com/nonpres/sacnpd_a_ccsmnl_o_2012-11-16-eng.php

Draft Agenda: A draft agenda for the Scientific Advisory Committee on Respiratory and Allergy Therapies (SAC-RAT) meeting on October 26, 2012 is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-com/resp_allerg/sacrat_a_ccstrta_o_2012-10-26-eng.php

Summary Basis of Decision: A Summary Basis of Decision is available for Latuda.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2012_latuda_145406-eng.php

Meeting: Information is available on the Scientific Advisory Committee on Pharmaceutical Sciences and Clinical Pharmacology meeting that was held on June 26-27, 2012 in Ottawa as well as the Draft Agenda for the December 10-11, 2012 meeting in Ottawa.

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-com/pharma/sacpscp_tor_ccssppc_att-eng.php
(Terms of Reference)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-com/nonpres/sacnpd_ccsmvl_m_bio-eng.php
(Membership List and Biographies)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-com/pharma/sacpscp_ccssppc_ai-eng.php
(Summary of Expertise, Experience and Affiliations and Interest)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-com/pharma/sacpscp_a_ccssppc_o_2012-12-10_11-eng.php
(Draft Agenda)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-com/pharma/sacpscp_a_ccssppc_o_2012-06-26_27-eng.php
(Agenda from June 26-27, 2012 held in Ottawa)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-com/pharma/sacpscp_rop_ccssppc_crd_2012-06-26_27-eng.php
(Record of Proceedings)

Drug and Medical Device Recall Listings: The Drug and Medical Device Recall listings have been updated.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/index-eng.php

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

Canadian Intellectual Property Office (CIPO)

Agreement: A new Patent Prosecution Highway (PPH) pilot project between the Canadian Intellectual Property Office (CIPO) and the Israel Patent Office (ILPO) will commence on November 1, 2012, for a period of two years ending on October 31, 2014.
http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr03564.html

 

 

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HEADS-UP October 8, 2013

Notices of Compliance - October 1 - 5, 2012

• Esbriet (pirfenidone) was approved as an anti-fibrotic; anti-inflammatory agent on 2012-10-01.

News from Health Canada

Health Canada

Health Advisory: Avmor Ltd. is voluntarily recalling one lot of its Antimicrobial Foaming Hand Soap (Triclosan 0.3%) due to microbial contamination. Product testing undertaken by Health Canada detected bacteria (Pseudomonas aeruginosa) that may pose serious health risks to people, especially those with weakened immune systems.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_151-eng.php

Therapeutic Products Directorate (TPD)

Epicardial Pacemaker Leads: Health Canada would like to inform you about the potential risk of cardiac strangulation, a rare adverse event associated with epicardial pacemaker leads implanted in pediatric patients.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2012/epicardial_leads_nth-aah-eng.php

Summary Basis of Decision: A Summary Basis of Decision is available for Xiaflex.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2012_xiaflex_147788-eng.php

Meeting: A notice announcing a forthcoming meeting of the Expert Advisory Committee on the Vigilance of Health Products (EAC-VHP) on October 24-25, 2012, in Ottawa is available.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advise-consult/eacvhp-ccevps/agenda-ordre-2012-10-eng.php

Notice of Decision: A Notice of Decision has been issued for Treanda.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/nd_ad_2012_treanda_149814-eng.php

Notice of Decision: A Notice of Decision has been issued for Medtronic Corevalve System.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/md-im/nd_ad_2012_corevalve_174668-eng.php

Summary Basis of Decision: A Summary Basis of Decision is available for Prochymal.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2012_prochymal_150026-eng.php

Drug and Medical Device Recall Listings: The Drug and Medical Device Recall Listings have been updated.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/index-eng.php

Notice: Errata: A revised version of the Therapeutic Products Directorate's (TPD) Drug Submission Performance Annual Report, Fiscal Year 2011-2012 is now available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/docs/perform-rendement/tpd_dpt_annual_fy_2011_2012_notice_avis-eng.php

National Interest

Pharmaceutical Advertising Advisory Board (PAAB)

Newsletter: The October 2012 issue of the PAAB Views is available.
http://www.paab.ca/resources/newsletters/PAAB_Views_October_2012_E.pdf
 

 

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HEADS UP - September 24, 2012

Notices of Compliance - September 17 - 21, 2012

• There were no new NOCs published during this week.

News from Health Canada

Health Canada

Announcement: The Honourable Leona Aglukkaq, Minister of Health, today announced two initiatives aimed at bringing new hope to Canadians with rare diseases: the Harper Government will create a new approach for the authorization of "orphan drugs" and announced the Canadian launch of Orphanet - a comprehensive database of information and services for rare diseases.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2012/2012-147-eng.php

Announcement: The Government of Canada tabled its response to the Standing Senate Committee on Social Affairs, Science and Technology report Time for Transformative Change: A Review of the 2004 Health Accord.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2012/2012-143-eng.php

Announcement: The Honourable Leona Aglukkaq, Minister of Health, announced today that the Harper Government has delivered on its promise to make MDPV, a drug commonly found in "bath salts",  illegal to possess, traffic, import or export, unless authorized by regulation.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2012/2012-144-eng.php

Natural Health Products Directorate (NHPD)

Meeting: The Natural Health Products Directorate (NHPD) will host a series of stakeholder workshops in Calgary, Vancouver, Toronto and Montreal on the New Approach to Natural Health Products.
 

Therapeutic Products Directorate (TPD)

Notice: Health Canada is pleased to share a revised DRAFT 2nd Edition Guidance Document for Cell, Tissue and Organ Establishments: Safety of Human Cells, Tissues and Organs for Transplantation (CTO Guidance document) for consultation.
http://www.hc-sc.gc.ca/dhp-mps/consultation/biolog/cell-eng.php

Notice:  Health Canada has issued a Notice regarding Revisions to the Draft Guidance Document: The Use of Foreign Reviews by Health Canada
and revisions to the Use of Foreign Reviews pilot project.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/for_rev-exam_etr/draft_foreign_rev_ebauche_exam_etra-eng.php

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/for_rev-exam_etr/foreign_rev_attest_exam_etra-eng.php
(Foreign Review Attestation Form (for human and veterinary biologics, disinfectants, radiopharmaceuticals and pharmaceuticals, and medical devices products)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/for_rev-exam_etr/foreign_rev_sdq_exam_etra_dtq-eng.php
(Foreign Review Attestation and Summary of Quality Differences: Subsequent Market Entry Products (Human Drugs))

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/for_rev-exam_etr/foreign_rev_faq_exam_etra-eng.php
(Frequently Asked Questions (FAQs) – The Use of Foreign Reviews by Health Canada)

Drug and Medical Device Recall Listings: The Drug and Medical Device Recall Listings have been updated.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/index-eng.php

Update: The quarterly update to the Canada Vigilance Adverse Reaction Online Database has taken place.
http://www.hc-sc.gc.ca/dhp-mps/medeff/databasdon/index-eng.php

Newsletter: The Canadian Adverse Reaction Newsletter, Volume 22 - Issue 4 - October 2012 is available.
http://www.hc-sc.gc.ca/dhp-mps/medeff/bulletin/carn-bcei_v22n4-eng.php

National Interest

Gazette I

Food and Drug Regulations: Regulations amending the Food and Drug Regulations (1475 ― Good Manufacturing Practices) are available.
http://www.gazette.gc.ca/rp-pr/p1/2012/2012-09-29/html/reg3-eng.html

Advertising Standards Canada (ASC)

Newsletter: The ASC Fall 2012 Newsletter is available.
http://www.adstandards.com/en/ASCLibrary/newsletters/fall2012/newsletter_ASCNews.aspx

Canadian Intellectual Property Office (CIPO)

PPH Pilot Project Agreements: Three expiring Patent Prosecution Highway (PPH) pilot project agreements between Canada and Finland, Germany, and Spain are being extended.
http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr03555.html

Patent Rules Amendments: CIPO published proposed amendments to the Patent Rules in Part I of the Canada Gazette on September 29, 2012. http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr03557.html

Patent Rules Amendments: As of September 29, 2012, proposed amendments to the Patent Rules and the Trade-marks Regulations have been published in Part I of the Canada Gazette.
http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr03558.html

Deposit Accounts: Important information regarding a new method of payment for deposit account replenishment is available.
http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr03556.html
 
Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 2, No. 31 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-2-31

Newsletter: The newsletter, CDR Update - Issue 82, discusses the CDR Consultation which is due October 15, 2012.
http://www.cadth.ca/en/products/cdr/cdr-update/cdr-update-82

Patented Medicine Prices Review Board (PMPRB)

Notice: The Board has issued a Notice of Hearing in the matter Galderma Canada Inc. and the medicine Tactuo.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=301

Board Decision: The August 1, 2012 Board Decision on the Merits in the matter of Sandoz Canada Inc. is re-issued.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=302

National Association of Pharmacy Regulatory Authorities (NAPRA)

Notice: The National Drug Scheduling Advisory Committee (NDSAC) is soliciting nominations to fill an upcoming membership vacancy.
http://napra.ca/pages/Schedules/drug_schedules_notice_board.aspx?id=3131
 

 

~~~~~

HEADS UP - September 17, 2012

Notices of Compliance - September 10 - 14, 2012

• There were no new NOCs published during this week.

News from Health Canada

Natural Health Products Directorate (NHPD)

Agenda: The agenda for the 2012 Health Products and Food Branch (HPFB) International Regulatory Forum on September 24-28, 2012 in Ottawa is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/int/forum/hpfb_dgpsa_forum_agenda_odj_2012-eng.php

Consultation: The Natural Health Products Directorate (NHPD) is seeking feedback on ten newly introduced monographs for ingredients. 
http://hc-sc.gc.ca/dhp-mps/consultation/natur/pre-cleared_information_preautorisee-sept_25-eng.php

Therapeutic Products Directorate (TPD)

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

Guidance: The Guidance Document: Process Validation: Form-Fill-Seal for Drugs (GUI-0008) is now available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/validation/gui_0008-eng.php

Standard: The Standard for the Fabrication, Control and Distribution of Antimicrobial Agents for Use on Environmental Surfaces and Certain Medical Devices (GUI-0049) is now available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/pol/gui_49-eng.php

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 2, No. 30 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-2-30
 

 

~~~~~

HEADS UP - September 10, 2012

Notices of Compliance - September 3 - 7, 2012

• There were no new NOCs published during this week.

News from Health Canada

Health Canada

Health Advisory: “Zhuifeng Tougu Wan”, an unauthorized natural health product, is being voluntarily recalled after testing identified levels of mercury that are far beyond the allowable limit set by Health Canada.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_140-eng.php

Immunocyst: As a follow-up to their July 11, 2012 communication on the cancer bladder treatment ImmuCyst, Health Canada has cleared for release one lot of the product that was being held due to problems in the facility where it was produced.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_139-eng.php

HPFB Inspectorate

Agenda: The agenda for the 2012 Health Products and Food Branch (HPFB) International Regulatory Forum is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/int/forum/hpfb_dgpsa_forum_agenda_odj_2012-eng.php

Therapeutic Products Directorate (TPD)

Health Care Professional Advisory

Propofol Injectable Emulsion: Hospira Healthcare Corporation is bringing to your immediate attention, a recall of one lot of Propofol Injectable Emulsion 1%, 10mg/mL, lot 09029DJ (expiry date 2014/09/01), that was initiated on September 7, 2012.
http://hc-sc.gc.ca/dhp-mps/alt_formats/pdf/medeff/advisories-avis/prof/2012/propofol_2_hpc-cps-eng.pdf

Meeting: Information is available on the Scientific Advisory Committee on Respiratory and Allergy Therapies meetings that was held on March14, 2012.

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-com/resp_allerg/sacrat_a_ccstrta_o_2012-03-14-eng.php
(Agenda)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-com/resp_allerg/sacrat_ccstrta_ai-eng.php
(Summary of Expertise, Experience and Affiliations and Interest)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-com/resp_allerg/sacrat_ccstrta_m_bio-eng.php
(Membership List and Biographies)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-com/resp_allerg/sacrat_rop_ccstrta_crd_2012-03-14-eng.php
(Record of Proceedings)

Meeting: Information is available on the Scientific Advisory Committee on Nonprescription Drugs (SAC-NPD that was held on May 11, 2012.

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-com/nonpres/sacnpd_a_ccsmnl_o_2012-05-11-eng.php
(Agenda)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-com/nonpres/sacnpd_ccsmvl_ai-eng.php
(Summary of Expertise, Experience and Affiliations and Interest)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-com/nonpres/sacnpd_ccsmvl_m_bio-eng.php
(Membership List and Biographies)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-com/nonpres/sacnpd_rop_ccsmvl_crd_2012-05-11-eng.php
(Record of Proceedings)

Drug and Medical Device Recall Listings: The Drug and Medical Device Recall Listings have been updated.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/index-eng.php

Register or Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

Draft Agenda: A draft agenda for the Scientific Advisory Committee on Nonprescription Drugs meeting on November 16, 2012 is now available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-com/nonpres/sacnpd_draft_a_ccsmnl_ebauche_o_2012-11-16-eng.php

National Interest

Canadian Intellectual Property Office (CIPO)

Consultation Update: An update is available regarding the recent consultation period for practice respecting Inventive Concept, Statutory Subject Matter under the Patent Act, and Claims to Diagnostic Methods and Medical Uses.
http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr03554.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Meeting: ‘An Introduction to Network Meta-Analysis A 2-Day Workshop’ will be held on Ottawa on November 6 & 7, 2012.
http://www.cadth.ca/en/events/2012/an-introduction-to-network-meta-analysis-a-2-day-hands-on

Newsletter: The CADTH Communiqué, Volume 2, No. 29 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-2-29
 

~~~~~

HEADS UP - Sept 3, 2012

Notices of Compliance - August 27 - 31, 2012

• There were no new NOCs published during this week.

News from Health Canada

Health Canada

Health Advisory: Health Canada has issued an advisory that CuraHerbDistributor (curaherbdistributor.com) is attempting to sell online unlicensed home-use HIV test kits for use with urine, saliva and blood samples.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_137-eng.php

Therapeutic Products Directorate (TPD)

Notice to Hospitals
 
BiCNU: An announcement has been made regarding a precautionary recall of four (4) lots of BiCNU 100mg/vial due to overfilled vial discovered in another lot, not distributed in Canada.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2012/bicnu_2_nth-aah-eng.php

Guidance: The Guidance Document: Creation of the Canadian Module 1 Backbone is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ctd/ectd/ectd_mod1_guide-ld_fin-eng.php

Guidance: The Guidance Document: Risk Classification of Good Manufacturing Practices (GMP) Observations (GUI-0023) is now available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/docs/gui-0023-eng.php

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

Notice of Decision:  A Notice of Decision has been issued for Removab.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/nd_ad_2012_removab_142629-eng.php

Document: The document entitled ‘Health Product Vigilance Framework’ is available.
http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_fs-if/2012-hpvf-cvps/index-eng.php

National Interest

Patented Medicine Prices Review Board (PMPRB)

Notice: Updates have been made to the Form 1 and Form 2 cover sheet templates for regulatory filings.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=300
 

~~~~~

HEADS UP - August 20, 2012

Notices of Compliance - August 13 - 17, 2012

• There were no new NOCs published during this week.

News from Health Canada

Health Canada

Quarterly Financial Report: Health Canada has released its Financial Report for the Quarter ended June 30, 2012.
http://www.hc-sc.gc.ca/ahc-asc/performance/estim-previs/qfr-rft/2012-06-30-eng.php

Therapeutic Products Directorate (TPD)

Health Care Professional Advisory

GILENYA: Health Canada has reviewed the safety information on the multiple sclerosis drug, GILENYA. The label has been updated with respect to first-dose monitoring and use in patients with pre-existing cardiovascular conditions.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2012/gilenya_hpc-cps-eng.php

Consumer Health Advisory

GILENYA: Novartis Pharmaceuticals Canada Inc., in collaboration with Health Canada, would like to inform you about important new safety information for the multiple sclerosis drug, GILENYA.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2012/gilenya_pc-cp-eng.php

Food and Drug Regulations: Health Canada has issued an update on the proposal to amend Schedule F to the Food and Drug Regulations (Project 1663) for Manufacturers of pancrelipase, pancreatin and pancreatic extracts where the strength per dosage unit exceeds 20,000 USP units of lipase activity or when indicated for the treatment of pancreatic exocrine insufficiency.
www.jptcp.com/files/1663_Part_I_Prescribing_Information_20110606_eng_final.pdf

www.jptcp.com/files/1663_Part_II_Scientific_Information_2011_06_06_eng_final.pdf

www.jptcp.com/files/1663_Part_III_Consumer_Information_2011_06_06_eng_final.pdf

www.jptcp.com/files/1663_Chemistry_and_Manufacturing__2012_06_06_eng_final.pdf

www.jptcp.com/files/1663_email.8.27.2012.pdf

Summary Basis of Decision: A Summary Basis of Decision is available for Mentor Memorygel Silicone Gel-Filled Breast Implants.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/md-im/sbd_smd_2012_mentorround-69312-eng.php

Summary Basis of Decision: A Summary Basis of Decision is available for Aloxi.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2012_aloxi_145491-eng.php

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 2, No. 27 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-2-27

Newsletter: The CADTH Communiqué, Volume 2, No. 28 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-2-28

CADTH Review: Many Canadian jurisdictions are facing decisions about new oral anticoagulants for stroke prevention in patients with atrial fibrillation (the most common type of irregular heartbeat). CADTH’s review on the use of new oral anticoagulants to prevent stroke and other thromboembolic events in patients with atrial fibrillation led to a recommendation that these drugs be considered second-line options.
http://www.cadth.ca/en/media-centre/2012/british-columbias-ministry-of-health-uses-cadth-work
 

HEADS UP - August 13, 2012

Notices of Compliance - August 6 - 10, 2012

• There were no new NOCs published during this week.

News from Health Canada

Biologics and Genetic Therapies Directorate (BGTD)

Report: The Biologics and Genetic Therapies Directorate Drug Submission Performance Quarterly Report; April – June 2012 is available.
www.jptcp.com/files/bgtd_dpbtg_12_apr_jun_eng.pdf

Natural Health Products Directorate (NHPD)

Report: The NHPD Quarterly Report for the period of April 1, 2012 to June 30, 2012 (Quarter 1 of the 2012-2013 fiscal year) is available.
www.jptcp.com/files/2012_2013_Q1_Report___ENG.pdf

Therapeutic Products Directorate (TPD)

Draft Guidance: Health Canada is pleased to announce the release of the draft Guidance Document: Preparation of Summary Technical Document (STED)-based Class III and IV Premarket in vitro diagnostic device licence applications and amendments for a 60-day comment period.
http://www.hc-sc.gc.ca/dhp-mps/consultation/md-im/consult_md_gd_data_im_ld_donnees_ciii_civ_ivdd_sted-eng.php

http://www.hc-sc.gc.ca/dhp-mps/consultation/md-im/md_gd_data_im_ld_donnees_ciii_civ_ivdd_sted-eng.php
(Consultation Document)

Draft Guidance: Health Canada is pleased to announce the release of the draft Guidance Document: Guidance on supporting evidence to be provided for Class III and IV in vitro diagnostic medical device licence applications and amendments for a 60-day comment period.
http://www.hc-sc.gc.ca/dhp-mps/consultation/md-im/consult_md_gd_data_im_ld_donnee_ciii_civ_ivdd-eng.php

http://www.hc-sc.gc.ca/dhp-mps/consultation/md-im/md_gd_data_im_ld_donnee_ciii_civ_ivdd-eng.php
(Consultation Document)

Summary Basis of Decision: A Summary Basis of Decision is available for the MENTOR CPG Breast Implant.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/md-im/sbd_smd_2012_mentorcpg_86150-eng.php

Report: The Therapeutic Products Directorate Drug Submission Performance Quarterly Report; April – June 2012 is available.
www.jptcp.com/files/2012_2013_Q1_Report_cover_letter.pdf

Reminder for Sponsors: Health Canada has issued a reminder for sponsors regarding the International Conference on Harmonisation (ICH) E2A Guidance Document: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ich/efficac/e2a_pre_notice_avis-eng.php

Draft Guidance: Health Canada is pleased to announce the release of the draft guidance document, Biopharmaceutics Classification System Based Biowaiver, for stakeholder consultation.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult_bcs_draft_guide_ebauche_ld_scb-eng.php

Notice of Decision: A Notice of Decision has been issued for Inlyta.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/nd_ad_2012_inlyta_144404-eng.php

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

Drug and Medical Device Recall Listings: The Drug and Medical Device Recall Listings have been updated.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/index-eng.php

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CDR Update — Issue 81, clarifies that time frames for filing Pre-NOC Priority Review Submissions are in calendar days — effective immediately.
http://www.cadth.ca/en/products/cdr/cdr-update/cdr-update-81

 

~~~~~

HEADS UP - August 6, 2012

Notices of Compliance - July 30 – August 3, 2012

• There were no new NOCs published during this week.

News from Health Canada

HPFB Inspectorate

Notice: Health Products and Food Branch (HPFB) International Regulatory Forum 2012 will be held in Ottawa, Canada from September 24-28, 2012.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/int/forum/hpfb_dgpsa_notice_avis_forum_2012-eng.php

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/int/forum/hpfb_dgpsa_forum_reg_inscrip_2012-eng.php
(Request for Registration - Health Products and Food Branch (HPFB) International Regulatory Forum 2012 - September 24-28, 2012 - Ottawa, Canada).

Therapeutic Products Directorate (TPD)

Notice to Hospitals

Hospital Bed Entrapment: Health Canada has issued an important safety information update on the risk of entrapment of patients in hospital beds.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2012/hospital_bed-lit_hopital_2_nth-aah-eng.php

Guidance: A Guidance on Medical Device Compliance and Enforcement (GUI-0073) is available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/info-prod/md-im/gui-0073-eng.php

Notice of Decision: A Notice of Decision is available for Prochymal.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/nd_ad_2012_prochymal_150026-eng.php

Notice: Additional guidance on transition from the second to the third editions of the IEC 60601 Family of Standards on Health Canada's List of Recognized Standards is available.
http://www.hc-sc.gc.ca/dhp-mps/md-im/standards-normes/notice_iec_60601_avis-eng.php

National Interest

Federal Government

Chemical Substances Challenge: The Risk Management Action Milestones tables for Batch 2 and Batch 8 were published.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/risk_milestones-risques-statut-eng.php

Canadian Agency for Drugs and Technologies in Health (CADTH)
Newsletter: The CADTH Communiqué, Volume 2, No. 26 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-2-26

Consultation: The deadline for feedback on the draft Environmental Scan report on the Appropriate Utilization of Advanced Diagnostic Imaging Procedures has been extended to September 7, 2012.
http://www.cadth.ca/en/media-centre/2012/feedback-opportunity-deadline-extended

Pharmaceutical Advertising Advisory Board (PAAB)

Newsletter: The July 2012 issue of the PAAB Views is available.
http://www.paab.ca/resources/newsletters/PAAB_Views_JULY_2012_E.pdf

Meeting: ‘Understand the Boundaries and Opportunities of the PAAB Code to Increase Innovation’ will be held in Montreal on October 16, 2012 and in Toronto on October 18, 2012.
http://www.paab.ca/events/
 

~~~~~

HEADS UP - July 30, 2012

Notices of Compliance - July 23 - 27, 2012

• There were no new NOCs published during this week.

News from Health Canada

Health Canada

Natural Health Products Directorate (NHPD)

Document: The NHPD has published the document, “The regulation of natural health products (NHPs) in Canada myths and facts.”
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/about-apropos/nhp-myth-psn-eng.php

Site Licence Holder: A list of site licence holder and foreign site reference number data extracts are now available.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-site-exploit/sl-list-le-eng.php

Therapeutic Products Directorate (TPD)

Summary Basis of Decision: A Summary Basis of Decision (SBD) has been issued for Xalkori.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2012_xalkori_145155-eng.php

Drug and Medical Device Recall Listings: The Drug and Medical Device Recall Listings have been updated.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/index-eng.php

Notice of Decision: A Notice of Decision is available for Tretten.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/nd_ad_2012_tretten_152228-eng.php

Register of Innovative Drugs:  The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

Meeting: The meeting minutes are available for the April 18, 2012 meeting between BIOTECanada and Health Canada.
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/activit/meet-reunion/biotecanada-mm-crr-2012-04-18-eng.php

National Interest

Canadian Intellectual Property Office (CIPO)

News: Before coming into force, the Copyright Modernization Act will go through an order-in-council process over the coming months. For information on Bill C-11 receiving Royal Assent, read the news release.
http://www.ic.gc.ca/eic/site/crp-prda.nsf/eng/home

http://www.parl.gc.ca/HousePublications/Publication.aspx?Docid=5697419&file=4)
(Bill C-11: An Act to amend the Copyright Act; Copyright Modernization Act)

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 2, No. 25 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-2-25

Report: The report: Quality Assessment Tools Project is available.
http://www.cadth.ca/en/products/methods-and-guidelines/publication/3458

Patented Medicine Prices Review Board (PMPRB)

Voluntary Compliance Undertaking: The Chairperson of the Board accepted a Voluntary Compliance Undertaking (VCU) for Avonex PS.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=299
 

~~~~~

HEADS UP - July 23, 2012

Notices of Compliance - July 16 - 20, 2012

• Tretten (catridecacog) was approved as a coagulation factor on
2012-07-19.

News from Health Canada

Health Canada

Foreign Product Alerts: The following Foreign Product Alerts have been issued.

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2012/2012-127-eng.php
(Instant Hard Rod - RigiRx - Plus ZenMaxx)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2012/2012-126-eng.php
([Hu Qiu] Niu Huang Xiao Yan Wan)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2012/2012-125-eng.php
(Firminite, Extra Strength Instant Hot Rod, Libidron)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2012/2012-124-eng.php
(Boost - Ultra Sexual Enhancement Formula, EreXite, Mojo Nights)

http://hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2012/2012-128-eng.php
(VMaxx Rx)

Health Advisory: Health Canada is informing Canadians that it is assessing the possibility of an increased risk of cancer with long-term use of the drug calcitonin.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_122-eng.php

HPFB Inspectorate

Strategic Plan: The Health Products and Food Branch (HPFB) 2012-2015 Strategic Plan outlines HPFB's key strategic priorities for the next three years.
http://www.hc-sc.gc.ca/ahc-asc/pubs/hpfb-dgpsa/strat-plan-intro-eng.php

http://www.hc-sc.gc.ca/ahc-asc/alt_formats/pdf/pubs/hpfb-dgpsa/strat-plan-2012-2015-eng.pdf
(Health Products and Food Branch (HPFB) 2012-2015 Strategic Plan)

Therapeutic Products Directorate (TPD)

Health Care Professional Advisory

Pulmicort Turbuhaler: Health Canada is advising health care professionals of a potential device failure related to Pulmicort® Turbuhaler® (budesonide) powder for oral inhalation, 200 µg per metered dose (200 doses; DIN 00851752).
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2012/pulmicort_hpc-cps-eng.php

Consumer Health Advisory

Pulmicort Turbuhaler: AstraZeneca Canada Inc., in consultation with Health Canada, would like to inform you of important information regarding complaints related to the asthma medication, Pulmicort® Turbuhaler® (budesonide) powder for oral inhalation, 200 µg per metered dose (200 doses).
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2012/pulmicort_pc-cp-eng.php

Notice of Decision: A Notice of Decision is available for Xiaflex.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/nd_ad_2012_xiaflex_147788-eng.php

Summary Basis of Decision: A Summary Basis of Decision is available for the Symplicity Renal Denervation System.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/md-im/sbd_smd_2012_symplicity_189954-eng.php

Draft Guidance: The Draft Guidance Document: Acetylsalicylic Acid Labelling Standard is available.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult_asa_gd_draft_aas_ld_ebauche-eng.php

Notice: Health Canada has issued a Notice regarding the 2012 Annual Drug Notification and Fee Remission Request.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/announce-annonce/notice_adn_fee_rem_avis_dam_rem_frai-eng.php

Notice: As per the notice sent to all marketed Drug Identification Number (DIN) holders on May 4, 2012, Health Canada would like to remind sponsors that the Annual Drug Notification package is now being sent electronically.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/announce-annonce/notice_adnf_avis_fda-eng.php

Meeting: A Record of Discussions is available for the April 5, 2012 meeting between the Canadian Advertising Preclearance Agencies and Health Canada.
http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/meet-reunion/rod-rdd_2012_04_05-eng.php

Updated List: The List of Recognized Standards for Medical Devices has been updated.
http://www.hc-sc.gc.ca/dhp-mps/md-im/standards-normes/md_rec_stand_im_norm_lst-eng.php

National Interest

Patented Medicine Prices Review Board (PMPRB)

Newsletter: The PMPRB released the July 2012 issue of its NEWSletter.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=298
 

~~~~~

HEADS UP - July 16, 2012

Notices of Compliance - July 9 - 13, 2012

• Inlyta (axitinib) was approved as a kinase inhibitor; anti-tumour agent on 2012-07-12.

News from Health Canada

Health Canada

Health Advisory: Further to our previous communications, Health Canada is advising Canadians that four products promoted for weight loss have been seized from "U-Box," a store in Burnaby, B.C.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_119-eng.php

Health Advisory: "Fu Fang Zaoren Jiaonang," an unauthorized natural health product promoted for anxiety and/or insomnia, has been removed from sale after testing by Health Canada confirmed the presence of the ingredient L-tetrahydropalmatine that could cause damage to vital organs such as the liver, most notably in pregnant women.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_113-eng.php

Health Advisory: "Vine Essence" has been recalled after testing by Health Canada identified a quantity of lead that exceeds Departmental acceptable limits and low levels of undeclared acetaminophen. Infants, young children, pregnant women and breastfeeding women are particularly at risk.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_116-eng.php

Natural Health Products Directorate (NHPD)

Calendar of Activities: A Natural Health Products Directorate calendar of activities is available.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/activit/calend/index-eng.php

Therapeutic Products Directorate (TPD)

Notice of Decision: A Notice of Decision is available for Jakavi.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/nd_ad_2012_jakavi_151723-eng.php

Summary Basis of Decision: A Summary Basis of Decision is available for Onbrez Breezhaler.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2012_onbrez_breezhaler_143984-eng.php
 
Summary Basis of Decision: A Summary Basis of Decision is available for Yervoy.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2012_yervoy_138178-eng.php

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

Drug and Medical Device Recall Listings: The Drug and Medical Device Recall Listings have been updated.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/index-eng.php

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 2, No. 24 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-2-24

Report: The report: Evaluation Frameworks for Genetic Tests is available.
http://www.cadth.ca/products/environmental-scanning/environmental-scans/environmental-scan-37

Newsletter: The CADTH Communiqué, Volume 2, No. 23 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-2-23
 

~~~~~

HEADS UP - July 2, 2012

Notices of Compliance - June 25 - 29, 2012

• There were no new NOCs published during this week.

News from Health Canada

Health Canada

Health Advisory: Health Canada has completed a thorough health risk assessment of the bladder cancer treatment ImmuCyst produced at Sanofi Pasteur's manufacturing plant in Toronto.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_111-eng.php

Health Advisory: "Lightning Rod," an unauthorized sexual enhancement product, has been removed from sale from various retail outlets in Ontario, British Columbia and Saskatchewan after testing by Health Canada identified a hidden ingredient (hydroxythiohomosildenafil) that may pose serious risks to the health of Canadians.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_108-eng.php

Biologics and Genetic Therapies Directorate (BGTD)

Quarterly Report: The Biologics and Genetic Therapies Directorate Drug Submission Performance Quarterly Report; January – March 2012 is available.
www.jptcp.com/files/bgtd_dpbtg_12_jan_mar_eng.pdf

Annual Report: The Biologics and Genetic Therapies Directorate Drug Submission Performance Annual Report for the Fiscal Year 2011 – 2012; Apr 1 2011 – Mar 31 2012 is available.
www.jptcp.com/files/bgtd_dpbtg_annual_annuel_11_eng_3.pdf

Therapeutic Products Directorate (TPD)

Health Care Professional Advisory

Volibris: GlaxoSmithKline Inc., in consultation with Health Canada, would like to inform you of new safety information regarding the use of Volibris® in patients with idiopathic pulmonary fibrosis (IPF). Higher rates of disease progression or deaths were observed during a prematurely discontinued clinical trial in IPF patients treated with Volibris®.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2012/volibris_hpc-cps-eng.php

Consumer Health Advisory

Volibris: GlaxoSmithKline Inc., in consultation with Health Canada, would like to inform you of new safety information regarding the use of Volibris® in patients with idiopathic pulmonary fibrosis (IPF) [idiopathic means arising without a known cause].  Higher rates of disease progression or deaths were observed during a prematurely discontinued clinical trial in IPF patients treated with Volibris®.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2012/volibris_pc-cp-eng.php

Quarterly Report: The Therapeutic Products Directorate Drug Submission Performance Quarterly Report; January – March 2012 is available.
www.jptcp.com/files/tpd_dpt_12_jan_mar_eng.pdf

Annual Report: The Therapeutic Products Directorate Drug Submission Performance Annual Report for the Fiscal Year 2011 – 2012; Apr 1 2011 – Mar 31 2012 is available.
www.jptcp.com/files/tpd_dpt_annual_annuel_11_eng_1.pdf

Newsletter: The Canadian Adverse Reaction Newsletter, Volume 22 - Issue 3 - July 2012 is available.
http://www.hc-sc.gc.ca/dhp-mps/medeff/bulletin/carn-bcei_v22n3-eng.php

Updated Guidance: The updated Therapeutic Products Directorate (TPD) Guidance Document, Bulk Forming Laxatives - Labelling Standard is now available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/label-etiquet-pharm/laxb_laxm-eng.php

Summary Basis of Decision: A Summary Basis of Decision is available for Caprelsa.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2012_caprelsa_126822-eng.php

Summary Basis of Decision: A Summary Basis of Decision is available for Feraheme.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2012_feraheme_133250-eng.php

Canadian Module 1 Schema Version 2.2: Health Canada is pleased to announce the finalization of the Canadian Module 1 Schema Version 2.2. Amendments were made to the Canadian Module 1 Schema Version 2.1 as a result of comments received from stake holders during the 30-day consultation period ending April 30th, 2012.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ctd/ectd/ectd_schema_ebauche-eng.php

Checklist: A Drug Establishment Licence application completion checklist is available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/ren-doc/del_lepp_checklist_form-eng.php

Checklist: A Medical Device Establishment Licence application completion checklist is available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/ren-doc/mdel_leim_checklist_form-eng.php

Drug and Medical Device Recall Listings: The Drug and Medical Device Recall Listings have been updated.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/index-eng.php

National Interest

Federal Government

Announcement: The Canadian government announced that the Economic Action Plan 2012 funding allocated to science, technology and innovation includes $17 million over two years to further advance the development of alternatives to existing isotope production technologies.
http://news.gc.ca/web/article-eng.do?nid=685509

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 2, No. 21 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-2-21
 

 

~~~~~

 

HEADS UP - July 9, 2012

Notices of Compliance - July 2 - 6, 2012

• Xiaflex (collagenase clostridium histolyticum) was approved as a collagenase clostridium histolyticum on 2012-07-05.

News from Health Canada

Health Canada

Unauthorized Natural Health Product: "Fu Fang Zaoren Jiaonang," an unauthorized natural health product promoted for anxiety and/or insomnia, has been removed from sale after testing by Health Canada confirmed the presence of the ingredient L-tetrahydropalmatine that could cause damage to vital organs such as the liver, most notably in pregnant women.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_113-eng.php

Natural Health Products Directorate (NHPD)

Consultation: The Natural Health Products Directorate (NHPD) is seeking your feedback on eight newly proposed monographs for ingredients.
http://www.hc-sc.gc.ca/dhp-mps/consultation/natur/pre-cleared_information_preautorisee-eng.php

Advisory Council on Traditional Chinese Medicines: The Honourable Leona Aglukkaq, Minister of Health, along with Parliamentary Secretary, Colin Carrie, attended the inaugural meeting of the Advisory Council on Traditional Chinese Medicines (TCMs).
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2012/2012-115-eng.php

http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2012/2012-115bk-eng.php
(Fact Sheet)

http://www.hc-sc.gc.ca/dhp-mps/prodnatur/activit/com/tcm-mtc/index-eng.php
(Mandate, Membership List and Biographies)

Report: The Status of Applications Quarterly Report - Quarter 4 (Fiscal year 2011-2012) is available on the NHPD website.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/report-rapport/qar_tri_4-12-eng.php

Therapeutic Products Directorate (TPD)

Health Care Professional Advisory

ImmuCyst: An announcement has been made regarding the supply status of ImmuCyst. The supply of ImmuCyst® will be interrupted while Sanofi Pasteur renovates the production facility.
http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2012/immucyst_hpc-cps-eng.php

Summary Basis of Decision: A Summary Basis of Decision is available for Edarbi.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2012_edarbi_145305-eng.php

Notice of Decision: A Notice of Decision is available for Dificid.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/nd_ad_2012_dificid_151086-eng.php

Guidance: Health Canada has issued a Notice regarding implementation of the International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance: E2F: Development Safety Update Report (DSUR).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ich/efficac/e2f_dsur-eng.php

Notice of Decision: A Notice of Decision is available for Latuda.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/nd_ad_2012_latuda_145406-eng.php

Summary Basis of Decision: A Summary Basis of Decision is available for Fampyra.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2012_fampyra_132859-eng.php

Report: Health Canada is pleased to announce the release of the Therapeutic Products Directorate Statistical Report 2011 for the Patented Medicines (Notice of Compliance) Regulations and Data Protection.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/docs/patmedbrev/patmrep_mbrevrap_2011-eng.php

International Pharmacovigilance Symposium: On June 6, 2012, the Health Products and Food Branch (HPFB) hosted a half-day International Pharmacovigilance Symposium under the theme of federal post-market surveillance activities.
http://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hpfb-dgpsa/mhpd-dpsc/hpfb-dgpsa-sympo-2012-eng.php

(Presentations)

www.jptcp.com/files/HPFB_International_Symposium_June_6.pdf

National Interest

Canadian Intellectual Property Office (CIPO)

PPH Mottainai Guidelines: On July 15, 2012, CIPO will extend the PPH Mottainai guidelines with the patent offices of Finland, Japan, Spain, the United Kingdom and the United States.
http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr03535.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 2, No. 22 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-2-22

Patented Medicine Prices Review Board (PMPRB)

Regulatory Filing Reminder: The PMPRB has issued a reminder regarding Regulatory Filing.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=296

National Association of Pharmacy Regulatory Authorities (NAPRA)

Meeting: The proposed meeting of the National Drug Scheduling Advisory Committee for September 9-10, 2012 is cancelled. The next meeting of the Committee is scheduled for December 2-3, 2012. The deadline to receive submissions for a drug scheduling application for this meeting is by end of day Wednesday, October 3, 2012.
http://napra.ca/pages/home/default.aspx
 

 

~~~~~

 

HEADS UP - June 25, 2012

Notices of Compliance - June 18 - 22, 2012

• Jakavi (ruxolitinib) was approved as a Janus Associated Kinase 1,2 (JAK1,2) Inhibitor on 2012-06-19.

News from Health Canada

Health Canada

Health Advisory: Kimberly-Clark Professional Corporation is voluntarily recalling Kleenex-brand Luxury Foam Hand Sanitizer due to microbial contamination.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_105-eng.php

Health Advisory: Health Canada testing has identified that the weight loss product "ZXT Gold" bee pollen capsules contain hidden pharmaceutical ingredients (sibutramine and phenolphthalein), which may pose serious health risks.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_106-eng.php

Natural Health Products Directorate (NHPD)

Document: The NHPD has published the document, ‘A new approach to natural health products’.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/nhp-new-nouvelle-psn-eng.php

Therapeutic Products Directorate (TPD)

Guidance Document: Health Canada is pleased to announce the release of the final version of the Guidance Document: Guidance on supporting evidence to be provided for new and amended licence applications for Class III and Class IV medical devices, not including In Vitro Diagnostic Devices (IVDDs).
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/md_gd_data_im_ld_donnees_ciii_civ-eng.php

Summary Basis of Decision Phase II: Information is available on the Summary Basis of Decision Phase II.

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/announce-annonce/sbd_notice_launch_phaseii_smd_lance_avis-eng.php
(Launch Notice)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/sbd_qa_smd_fq-eng.php
(Frequently Asked Questions)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/background-contexte-eng.php
(Background)

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

Update: The Quarterly Update to the Canada Vigilance Adverse Reaction Online Database has taken place.
http://www.hc-sc.gc.ca/dhp-mps/medeff/databasdon/index-eng.php

Record of Proceedings: A Record of Proceedings is available for the December 2, 2011 meeting of the Scientific Advisory Committee on Medical Devices used in Cardiovascular System.
http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/sci-com/cardio/sacmducs_rop_ccsmmuac_crd_2011-12-02-eng.php

http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/sci-com/cardio/sacmducs_a_ccsmmuac_o_2011-12-02-eng.php
(Agenda)

National Interest

Federal Government

Copyright Modernization Act: On June 29, 2012, the Honourable Christian Paradis, Minister of Industry, and the Honourable James Moore, Minister of Canadian Heritage and Official Languages, announced that new legislation designed to modernize Canada's copyright laws has received Royal Assent.
http://news.gc.ca/web/article-eng.do?nid=683909

Gazette II

Food and Drug Regulations: Regulations amending the Food and Drug Regulations (Positron-emitting Radiopharmaceuticals) are available.
http://www.gazette.gc.ca/rp-pr/p2/2012/2012-07-04/html/sor-dors129-eng.html

Health Council of Canada (HCC)

EIHR Portal: The Health Council of Canada announced the availability of the EIHR Portal. The Evidence-Informed Healthcare Renewal Portal (EIHR Portal) is a single window into a continuously updated collection of reliable evidence that can guide healthcare leaders in their timely pursuit of health system renewal, transformation and innovation.
http://www.healthcouncilcanada.ca/cnt_nws.php?id=64

Organisation for Economic Co-operation and Development (OECD)

Report: Canada is not alone in putting the brakes on health spending. The Organisation for Economic Co-operation and Development reported this week that there was zero growth in health spending among OECD countries in 2010.
http://www.oecd.org/document/30/0,3746,en_2649_37407_12968734_1_1_1_37407,00.html
 

 

~~~~~

HEADS UP - June 18, 2012

Notices of Compliance - June 11 - 15, 2012

• Latuda (lurasidone hydrochloride) was approved as an antipsychotic on 2012-06-13.

News from Health Canada

Health Canada

Announcement: The Honourable Leona Aglukkaq, Minister of Health, announced Harper Government funding to allow the Canadian Institute for Health Information (CIHI) to continue its work of providing reliable data about the health care system.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2012/2012-104-eng.php

Health Advisory: "Natural Vigor Maximum" (Exemption Number: 138273) has been removed from sale from various retail outlets in Ontario after testing by Health Canada identified a hidden ingredient (dimethylhomosildenafil) that may pose serious risks to the health of Canadians.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_100-eng.php

Health Advisory: Health Canada has issued an advisory that counterfeit drugs may pose serious dangers to your health.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_101-eng.php

Natural Health Products Directorate (NHPD)

Policy: The Natural Health Products Directorate has released a Natural Health Product Raw Material Policy.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/pol/raw_policy-politique_premiere-eng.php

Therapeutic Products Directorate (TPD)

Notice to Hospitals

Paclitaxel for Injection: Hospira Healthcare Corporation, in consultation with Health Canada, would like to inform you that complaints were received from customers outside of Canada of visible vial defects for multiple products of Paclitaxel for Injection, 300mg/50mL.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2012/paclitaxel_nth-aah-eng.php

Guidance: Health Canada is pleased to announce the finalization of the Guidance Document: Preparation of Drug Regulatory Activities in the Common Technical Document (CTD) Format.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ctd/ctd_prep_nds-eng.php

Drug and Medical Device Recall Listings: The Drug and Medical Device Recall Listings have been updated.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/index-eng.php

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

Record of Decisions: A Record of Decisions is available for the November 29, 2011 meeting between Health Canada and the Canadian Consumer Specialty Products Association (CCSPA).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/assoc/2011-11-29-eng.php

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 2, No. 20 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-2-20

Report: The Environmental Scan report: SPECT-Related Technologies in Canada is available.
http://www.cadth.ca/en/products/environmental-scanning/environmental-scans/environmental-scan-34

Patented Medicine Prices Review Board (PMPRB)

Updated Document: The Board released its annual updated version of the Compendium of Policies, Guidelines and Procedures for 2012.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=295

http://www.pmprb-cepmb.gc.ca/CMFiles/LRG/Guidelines/Compendium-June2012-E-jun27.pdf
(Compendium of Policies, Guidelines and Procedures for 2012)

Report: The PMPRB has released its 2011 Annual Report.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=294

http://www.pmprb-cepmb.gc.ca/CMFiles/Publications/Annual%20Reports/2011/Communique-AR-2011-June-21-2012.pdf
(Communiqué)

http://www.pmprb-cepmb.gc.ca/english/View.asp?x=1626&mp=91
(Annual Report 2011: In Brief)

http://www.pmprb-cepmb.gc.ca/english/View.asp?x=1625&mp=91
(Annual Report 2011)

http://www.pmprb-cepmb.gc.ca/CMFiles/Publications/Annual%20Reports/2011/2011-AR-Patented-Drugs-List_EN_Final-for-Posting.pdf
(List of Patented Medicines)

National Association of Pharmacy Regulatory Authorities (NAPRA)

Committee Recruitment: Please be advised that there is a slight amendment to the description of one (1) of the NDSAC Committee vacancies.
http://napra.ca/Content_Files/Files/NDSAC_recruitment_notice_June2012_Final.pdf

Health Council of Canada (HCC)

Newsletter: The Health Council of Canada has released its Summer 2012 e-newsletter.
http://www.info-hcc-ccs.ca/20120618_hcc.asp?email=cfrench@canreg.ca
 

 

~~~~~

 

HEADS UP - June 11, 2012

Notices of Compliance - June 4 - 8, 2012

• Dificid (fidaxomicin) was approved as an antibacterial agent on 2012-06-07.

News from Health Canada

Health Canada

Health Advisory: Health Canada is advising Canadians that Sanofi Pasteur is voluntarily recalling all Bacille Calmette-Guérin (BCG) vaccine on the market because of problems in the manufacturing facility that Health Canada believes may have affected the vaccine quality.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_97-eng.php

Natural Health Products Directorate (NHPD)

Natural Health Products Ingredients Database: The Natural Health Products Ingredients Database has been updated on June 19, 2012.
http://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq.do?atid=whats.quoi&lang=eng

RSS Feed: The Health Products and Food Branch invites you to subscribe to the Really Simple Syndication (RSS) feed and obtain links to new Natural Health Products Ingredients Database information when it is posted online.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/feeds-fils/index-eng.php

Therapeutic Products Directorate (TPD)

Notice to Hospitals

HepaGam B: Cangene Corporation, in cooperation with the Health Canada, would like to inform you of planned changes to the Canadian Product Monograph for HepaGam B®, including pertinent precautions regarding thrombotic events.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2012/hepagam_nth-aah-eng.php

Consumer Health Advisory

HepaGam B: Cangene Corporation, in cooperation with the Health Canada, would like to inform you of the possibility of developing blood clots after receiving HepaGam B®.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2012/hepagam_pc-cp-eng.php

Summary Basis of Decision: A Summary Basis of Decision has been issued for Toviaz.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2012_toviaz_142326-eng.php

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

National Interest

Gazette I

Canadian Environmental Protection Act, 1999: A Notice has been issued with respect to certain methylenediphenyl diisocyanate and diamine, and phenol, methyl- substances.
http://www.gazette.gc.ca/rp-pr/p1/2012/2012-06-16/html/index-eng.html

Patent Act: The Patented Medicine Prices Review Board has proposed to submit the Patented Medicine Prices Review Board Rules of Practice and Procedure (the Rules) to the Governor in Council for formal approval.
http://www.gazette.gc.ca/rp-pr/p1/2012/2012-06-16/html/index-eng.html

Gazette II

Canadian Environmental Protection Act, 1999: The Minister of the Environment, pursuant to subsection 112(3) of the Canadian Environmental Protection Act, 1999, hereby makes the annexed Order 2012-112-04-14 amending the Domestic Substances List.
http://www.gazette.gc.ca/rp-pr/p2/2012/2012-06-20/html/sor-dors115-eng.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 2, No. 19 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-2-19

Patented Medicine Prices Review Board (PMPRB)

Decision & Order: The Hearing Panel in the matter of sanofi pasteur Limited and the medicines Quadracel and Pentacel issued its decision and Order following its reconsideration of the remedy.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=293

Publication: The proposed Patented Medicine Prices Review Board Rules of Practice and Procedure were published in the June 16, 2012 issue of the Canada Gazette.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=292

Industry Canada

Copyright Modernization Act, Bill C-11: The Honourable Christian Paradis, Minister of Industry, and the Honourable James Moore, Minister of Canadian Heritage and Official Languages, together welcome the passage by the House of Commons of the Copyright Modernization Act, Bill C-11. The Copyright Modernization Act now moves to the Senate for review and debate.
http://news.gc.ca/web/article-eng.do?nid=681139
 

 

~~~~~

 

HEADS UP - June 4, 2012

Notices of Compliance - May 28 – June 1, 2012

• There were no new NOCs published during this week.

On the Move

• The Chairperson of the Patented Medicine Prices Review Board, Mary Catherine Lindberg, is pleased to inform stakeholders of the appointment of Normand Tremblay as Board Member, for a five-year term. http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=289

News from Health Canada

Health Canada

Announcement: The Honourable Leona Aglukkaq, Minister of Health, and the Honourable Alice Wong, Minister of State for Seniors, announced a Harper Government investment in support of the development of new palliative care models.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2012/2012-94-eng.php

Therapeutic Products Directorate (TPD)

Annual Drug Notification Form: Instructions are available for the completion of the Annual Drug Notification Form - Human and Veterinary Drugs.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/announce-annonce/annual_guide_annuelle-eng.php

Notice of Decision: A Notice of Decision is available for Xalkori.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/nd_ad_2012_xalkori_145155-eng.php

Factsheet: A Factsheet is available on Drug Shortages.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/announce-annonce/shortage-rupture-eng.php

Summary Basis of Decision: A Summary Basis of Decision is available for Zelboraf.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2012_zelboraf_148693-eng.php

NOC/c-QN: This Notice of Compliance with Conditions Qualifying Notice (NOC/c-QN), issued in accordance with the Health Canada NOC/c Policy, is to advise you that information submitted in support of the New Drug Submission for Prochymal (remestemcel-L), Control Number 150026, for the indication of acute Graft versus Host Disease (aGvHD), qualifies to be considered for authorization under the NOC/c Policy.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/prochymal_qn_aa_150026-eng.php

National Interest

Gazette I

Controlled Drugs and Substances Act: A notice has been published which provides interested stakeholders with the opportunity to provide comments on Health Canada’s intent to add methylenedioxypyrovalerone (MDPV), namely 3,4-methylenedioxypyrovalerone and its salts, derivatives, isomers and analogues and salts of derivatives, isomers and analogues to Schedule I to the Controlled Drugs and Substances Act (CDSA).
http://www.gazette.gc.ca/rp-pr/p1/2012/2012-06-09/html/index-eng.html

Canadian Intellectual Property Office (CIPO)

Announcement: The Canadian Intellectual Property Office (CIPO)'s five-year Business Strategy – CIPO: Inspired by innovation; committed to success is now available.
http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr03523.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 2, No. 17 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-17

Newsletter: The CADTH Communiqué, Volume 2, No. 18 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-2-18

Patented Medicine Prices Review Board (PMPRB)

Webinar: The Regulatory Affairs and Outreach Branch presented a Webinar on the Follow-up recommendations on implementation of the DIP Methodology.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=291

Meeting Schedule: The Human Drug Advisory Panel has released its Meeting Schedule and Filing Requirements for 2013.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=290
 

 

~~~~~

HEADS UP - May 28, 2012

Notices of Compliance - May 21 -25, 2012

• Prochymal (remestemcel-L) was approved as an allogenic cellular therapy on 2012-05-22.

News from Health Canada

Health Canada

Health Advisory: The Honourable Leona Aglukkaq, Minister of Health, announced that the Harper Government plans to regulate MDPV, a key ingredient in the illicit drug referred to as "bath salts", under the Controlled Drugs and Substances Act (CDSA).
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2012/2012-93-eng.php

Foreign Product Alerts: The following Foreign Product Alerts are available.

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2012/2012-91-eng.php
(Q & N Omega Tree)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2012/2012-90-eng.php
(Ling Zhi She Xiang Tong Mai Dan)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2012/2012-89-eng.php
(Koff & Kold - Kold Sore)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2012/2012-88-eng.php
(Japan Weight Loss Blue; Japan Rapid Weight Loss Diet Pills Green; Japan Rapid Weight Loss Diet Pills Yellow)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2012/2012-87-eng.php
(Mince Belle (30 Capsules); Everlax (30 Capsules); Ever Slim (30 Capsules); Ever Slim Shake Mix (Strawberry) (17.6 oz); Ever Slim Shake Mix (Chocolate) (17.6 oz); Acai-Man Mangosteen Herbal Drink (16.6 oz))

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2012/2012-92-eng.php
(RegenArouse (Lot Number 130100) - RegenErect (all lots))

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2012/2012-86-eng.php
(African Black Ant, France T253, Hard Ten Days, Man King, Stree Overlord)

Biologics and Genetic Therapies Directorate (BGTD)

Record of Decisions: A Record of Decisions is available for the April 3, 2012 meeting between the Nuclear Medicine Alliance (NMA) and the Biologics and Genetic Therapies Directorate (BGTD).
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/activit/meet-reunion/nma-mm-crr-2012-04-03-eng.php

Therapeutic Products Directorate (TPD)

Notice to Hospitals

IntelliVue Patient Monitors: Philips Healthcare, in collaboration with Health Canada, is providing this letter to inform you of a potential safety issue that may affect the IntelliVue Patient Monitors.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2012/philips_patient_mon_nth-aah-eng.php

Privigen: CSL Behring Canada, Inc. (CSLB), in collaboration with Health Canada, would like to inform you of a recent labeling update regarding the risk of hemolysis following Privigen® administration.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2012/privigen_nth-aah-eng.php 

Health Care Professional Advisory

XGEVA: Amgen Canada Inc., in consultation with Health Canada, would like to inform you of new important safety information related to hypocalcemia associated with XGEVA treatment.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2012/xgeva_hpc-cps-eng.php

Consumer Health Advisory

XGEVA: Amgen Canada Inc., in consultation with Health Canada, would like to inform you of new important safety information related to hypocalcemia (low calcium levels in the blood) associated with the use of XGEVA.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2012/xgeva_pc-cp-eng.php

Privigen: CSL Behring Canada, Inc. (CSLB), in collaboration with Health Canada, would like to inform you of the risk of hemolysis (damaged or destroyed red blood cells) and hemolytic anemia (where you have less red blood cells because many of them have been either damaged or destroyed) associated with the use of Privigen®.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2012/privigen_pc-cp-eng.php

Summary Basis of Decision: A Summary Basis of Decision is available for Resotran.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2012_resotran_141157-eng.php

Notice: A Notice has been issued announcing a forthcoming meeting of the newly formed Health Products and Food Branch (HPFB) Scientific Advisory Committee on Pharmaceutical Sciences and Clinical Pharmacology (SAC-PSCP).  A portion of this meeting will be open to all stakeholders and participation is hereby invited.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-com/pharma/sacpscp_ccssppc_anno-eng.php

Notice: Health Canada has issued a Notice regarding the Categorization of Therapeutic Products at the Device / Drug Interface.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/pol/notice_dev_drug_categ_instr_drog_avis-eng.php

Drug and Medical Device Recall Listings: The Drug and Medical Device Recall Listings have been updated.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/index-eng.php

Consultation: Physicians are invited to participate in an online consultation on the role of physicians regarding the proposed improvements to the Medical Marihuana Program.
http://www.consultations.hc-sc.gc.ca/public-consult/consultations/calendar-calendrier/consultation-eng.php?id=668

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 2, No. 16, is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-2-16

Health Council of Canada (HCC)

Progress Report: The Health Council of Canada has released the Progress Report 2012: Health care renewal in Canada, highlighting the progress achieved by governments to date in five key areas: home and community care, health human resources, telehealth, access to care in the North, and comparable health indicators since the 2003 health accord was signed.
http://www.healthcouncilcanada.ca/cnt_nws.php?id=61
 

 

~~~~~

HEADS UP - May 21, 2012

Notices of Compliance - May 14 - 18, 2012

• There were no new NOCs published during this week.

News from Health Canada

Health Canada

Foreign Product Alerts: The following Foreign Product Alerts are available.

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2012/2012-78-eng.php
(AdvanceMen capsules and Miraculous Evil Root tablets)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2012/2012-79-eng.php
(CanSui; Lexscl Fat Rapid Loss Capsule; The Extreme-thin Fat Burning Bomb; Xiu Zhi Su L-Carnitine Slimming Capsule)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2012/2012-80-eng.php
([Chung Lien Kulin Brand] Anshen Bunai Pian)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2012/2012-81-eng.php
(Jin Yu Tang Tai Han Kang Pai Pu Ling Jiao Nang; TangBaoKouFuYiDaoSuJiaoNang; Tangren 365 Kangxunpai sangge huoyisu jiaonang; Tong Ren Xiu Fu Kou Fu Yi Dao Su)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2012/2012-82-eng.php
(Lipro Diet Pills; Xiyouji Qingzhi weight loss capsules)

Biologics and Genetic Therapies Directorate (BGTD)

Draft Guidance: Health Canada is pleased to announce the release of the Draft Guidance Document - Interpreting the Blood Regulations for stakeholder consultation.
http://www.hc-sc.gc.ca/dhp-mps/consultation/biolog/blood-sang-eng.php

Therapeutic Products Directorate (TPD)

Meeting: A Record of Decisions is available for the November 30, 2011 meeting between Health Canada and Canada's Medical Device Technology Companies (MEDEC).
http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/meet-reunion/2011-11-30-eng.php 

SOP: The Standard Operating Procedures (SOP) - Using the Pharmaceutical Safety and Efficacy Assessment Template (PSEAT) to Prepare Reports on Periodic Safety Update Reports for Products Authorized under the Notice of Compliance with Conditions Policy (PSUR-C) is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/proj/practice-pratique/grp_saf_bpe_inn-eng.php

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

Publication: The review of the Canadian Agency for Drugs and Technologies in Health (CADTH) on antiseptic skin preparations and application techniques to prevent surgical site infections (SSIs) has been published in Infection Control & Hospital Epidemiology (ICHE).
http://www.cadth.ca/en/media-centre/2012/5/30/publication-of-cadth-review-examining-preoperative

Patented Medicine Prices Review Board (PMPRB)

Voluntary Compliance Undertaking: The Chairperson of the Board accepted a Voluntary Compliance Undertaking (VCU) for Diflucan.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=286

Voluntary Compliance Undertaking: The Chairperson of the Board accepted a Voluntary Compliance Undertaking (VCU) for Pariet.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=287

Voluntary Compliance Undertaking: The Chairperson of the Board accepted a Voluntary Compliance Undertaking (VCU) for Trileptal.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=288

Canadian Institute for Health Information (CIHI)

Report: The report, Health Indicators 2012, has been released.
http://www.cihi.ca/CIHI-ext-portal/internet/en/Document/health+system+performance/indicators/health/RELEASE_24MAY12

Health Council of Canada (HCC)

Announcement: The Health Council of Canada will release a progress report on health care renewal in Canada on June 4, 2012.
http://www.healthcouncilcanada.ca/cnt_nws.php?id=57
 

 

~~~~~

 

HEADS UP - May 14, 2012

Notices of Compliance - May 7 - 11, 2012

• There were no new NOCs published during this week.

News from Health Canada

Health Canada

Unauthorized Health Products: Unauthorized health products, "X-Rock", "Kaboom" and "One for Her" have been removed from sale from various retail outlets in British Columbia and Saskatchewan.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_77-eng.php

Universal Health Coverage: The Honourable Leona Aglukkaq, Minister of Health, affirmed the Government of Canada's commitment to universal health coverage during the plenary session of the 65th World Health Assembly.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2012/2012-75-eng.php

Mental Health Issues: The Honourable Leona Aglukkaq, Minister of Health, led an international roundtable to discuss common challenges and promising practices in addressing mental health issues.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2012/2012-76-eng.php

Health Advisory: Further to previous communications, Health Canada is advising Canadians that a new website has been identified selling "MMS", also known as Miracle Mineral Solution or Miracle Mineral Supplement.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_74-eng.php

Biologics and Genetic Therapies Directorate (BGTD)

Expert Advisory Panel on Prochymal: The membership list and the Report of the Expert Advisory Panel on Prochymal are available.
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/activit/sci-consult/prochymal/index-eng.php

http://www.hc-sc.gc.ca/dhp-mps/brgtherap/activit/sci-consult/prochymal/report-rapport-eng.php
(Report)

Natural Health Products Directorate (NHPD)

Consultation: The revised draft guidance document - pathway for licensing natural health products used as traditional medicines is available for comment.
http://hc-sc.gc.ca/dhp-mps/consultation/natur/tradit-eng.php

http://hc-sc.gc.ca/dhp-mps/consultation/natur/consult_tradit-eng.php
(Guidance Document)

Consultation: The revised draft guidance document - pathway for licensing natural health products making modern health claims is available for comment.
http://hc-sc.gc.ca/dhp-mps/consultation/natur/modern-eng.php

http://hc-sc.gc.ca/dhp-mps/consultation/natur/consult_modern-eng.php
(Guidance document)

Therapeutic Products Directorate (TPD)

Notice to Hospitals

Colleague Single Channel and Triple Channel Volumetric Infusion Pumps: Baxter Corporation, in collaboration with Health Canada, is providing this letter to make you aware of potential issues that may be observed with Colleague P1.5 Single Channel and Triple Channel Volumetric Infusion Pumps.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2012/infusion-perfusion_pump-pompe_9_nth-aah-eng.php

Guidance: The new Guidance Document: Conduct and Analysis of Comparative Bioavailability Studies is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/bio/gd_cbs_ebc_ld-eng.php

Guidance: The new Guidance Document - Comparative Bioavailability Standards: Formulations Used for Systemic Effects is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/bio/gd_standards_ld_normes-eng.php

SOP: The Standard Operating Procedures (SOP) - Using the Pharmaceutical Safety and Efficacy Assessment Template for Advanced Consideration of Requests for Notice of Compliance with Conditions or Priority Review (PSEAT-AC) to Prepare Reports is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/proj/practice-pratique/grp_bpe_advconsid_expre_sop_pon-eng.php

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The newsletter, CADTH Communiqué, Volume 2, No. 15, is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-2-15

Newsletter: The newsletter, CDR Update - Issue 80, discusses queuing of submissions for review through the Common Drug Review (CDR).
http://www.cadth.ca/en/products/cdr/cdr-update/cdr-update-80

 

 

~~~~~

 

HEADS UP - May 7, 2012

Notices of Compliance - April 30 – May 4, 2012

• There were no new NOCs published during this week.

News from Health Canada

Health Canada

Recall: Health Canada is advising Canadians that Church & Dwight Canada has initiated a voluntary recall of its "Spinbrush Pro Clean SONIC Recharge Toothbrushes" distributed in Canada and the U.S. The company has advised Health Canada that the recall is due to the risks, including fire, shock or burns posed by the charging base overheating.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_68-eng.php

Announcement: The Federal Government has introduced new regulations proposing that midwives, nurse practitioners and podiatrists be allowed to prescribe selected medications containing legal controlled substances.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2012/2012-71-eng.php

http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2012/2012-71bk-eng.php
(Fact sheet)

Biologics and Genetic Therapies Directorate (BGTD)

Expert Advisory Committee: Updated information is available on the Expert Advisory Committee on Cells, Tissues, and Organs (EAC-CTO).

http://www.hc-sc.gc.ca/dhp-mps/brgtherap/activit/com/eaccto-ccecto/2012-02-02-eng.php
(Teleconference Agenda - February 2, 2012)

http://www.hc-sc.gc.ca/dhp-mps/brgtherap/activit/com/eaccto-ccecto/memb-ai-eng.php
(Summary of Expertise, Experience and Affiliations and Interests)

Therapeutic Products Directorate (TPD)

Report: The report entitled, "A National Medical Devices Strategy for Canada: Results of a Stakeholder Driven Consultation Process", is available. Planning is currently underway for the 2012 Medical Devices Summit entitled, "Implementing the National Medical Devices Strategy" tentatively scheduled to take place October 4-5, 2012 at the Westin Ottawa Hotel and Conference Centre.  
www.jptcp.com/files/National_Medical_Devices_Strategy_for_Canada.pdf

SOP: The Standard Operating Procedures (SOP) - Using the Pharmaceutical Safety and Efficacy Assessment Templates (PSEATs) to Prepare Reports on Submissions for Marketing Authorizations is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/proj/practice-pratique/grp_bpe_procedure-eng.php

Updated Listings: The Drug and Medical Device Recall Listings have been updated.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/index-eng.php

National Interest

Advertising Standards Canada (ASC)

Newsletter: The ASC Spring 2012 Newsletter is available.
http://www.adstandards.com/en/ASCLibrary/newsletters/spring2012/newsletter_ASCNews.aspx

Canadian Intellectual Property Office (CIPO)

Report: CIPO's 2010-2011 Annual Report was tabled in the House of Commons on May 11, 2012.
http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr03522.html

Patented Medicine Prices Review Board (PMPRB)

DIP Methodology Report: The DIP Methodology Technical Working Group has released its Follow-up Recommendations on the Implementation of the DIP Methodology.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=285

National Association of Pharmacy Regulatory Authorities (NAPRA)

Call for Committee Nominations: The National Drug Scheduling Advisory Committee (NDSAC) is soliciting nominations to fill membership vacancies. Specifically at this time, the Committee is looking for three (3) nominations in the following areas:

• An individual with expertise in pharmacotherapy and/or drug utilization preferably a family physician
• An academic expert in drug use, with teaching and/or research experience preferably in the area of nonprescription medicines
• An individual with expertise in regulatory affairs in the pharmaceutical industry

The deadline to receive nominations is no later than June 29, 2012.
http://napra.ca/pages/home/default.aspx?id=3088

Health Council of Canada

Report: The report, Self-management support for Canadians with chronic health conditions: A focus for primary health care, is available. The report explores how self-management support can improve patient outcomes and better integrate the health system for this purpose. It profiles a range of practices and calls for targeted investments in self-management support strategies.
http://www.healthcouncilcanada.ca/cnt_nws.php?id=51

 

 

~~~~~

 

HEADS UP - April 30, 2012

Notices of Compliance - April 23 - 27, 2012

• Xalkori (crizotinib) was approved as an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor on 2012-04-25.

On the Move

• Following a term as NAPRA’s Vice President, Diane Brideau-Laughlin was acclaimed as the National Association of Pharmacy Regulatory Authorities’ (NAPRA) President for 2012-2013 during the recent Board of Directors meeting held in Ottawa. http://napra.ca/Content_Files/Files/NR_New_NAPRA_President_BrideauLaughlin_May2012_Final.pdf

• Advertising Standards Canada has announced its 2012/2013 Board of Directors. John Coyne has been elected Chair of the Board for the coming year.  http://www.adstandards.com/en/MediaAndEvents/2012BoardOfDirectorsPressRelease.aspx

News from Health Canada

Health Canada

Report: Health Canada has released the report entitled, “2012–13 Part III - Reports on Plans and Priorities (RPP)”.
http://www.tbs-sct.gc.ca/rpp/2012-2013/index-eng.asp?acr=1966
 
http://www.hc-sc.gc.ca/ahc-asc/performance/estim-previs/plans-prior/2012-2013-smr-drd-eng.php
(Future-oriented Financial Statements 2012-2013)

Consumer Advisory: Health Canada is informing Canadians of a labelling update for the prescription drug Cipralex (the brand name of the drug escitalopram) regarding a dose-related risk of abnormal heart rhythms.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_63-eng.php

Announcement: The Honourable Leona Aglukkaq, Minister of Health, announced that the Harper Government will invest heavily in neuroscience research by creating the Canada Brain Research Fund.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2012/2012-60-eng.php

Announcement: The Honourable Leona Aglukkaq, Minister of Health, welcomed the release of the Mental Health Commission's Mental Health Strategy for Canada.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2012/2012-66-eng.php

Natural Health Products Directorate (NHPD)

Report: The NHPD Quarterly Report for the period of January 1, 2012 to March 31, 2012 (Quarter 4 of the 2011-2012 fiscal year) is available.
www.jptcp.com/files/2011_2012_Q4_Report_Eng.pdf

Therapeutic Products Directorate (TPD)

Health Care Professional Advisory

Metal-on-Metal Hip Implant Surgery: Health Canada has issued important safety information on Metal-on-Metal Hip Implant Surgery.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2012/metal_implant_hpc-cps-eng.php

Benlysta: GlaxoSmithKline Inc., in consultation with Health Canada, would like to inform you of important new safety information related to hypersensitivity and infusion reactions associated with Benlysta™ (belimumab) treatment.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2012/benlysta_hpc-cps-eng.php

Revlimid: Celgene Inc., in consultation with Health Canada, would like to inform you of important new safety information which has been added to the Product Monograph for Revlimid® (lenalidomide) capsules.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2012/revlimid_hpc-cps-eng.php

Consumer Health Advisory

Metal-on-Metal Hip Implant Surgery: Health Canada has issued a Health Care Professional letter to Canadian orthopaedic surgeons informing them about potential health risks and recommending patient management strategies following metal-on-metal (MoM) hip implant surgery.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2012/metal_implant_pc-cp-eng.php

Benlysta: Health Canada has endorsed important safety information on Benlysta (belimumab).
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2012/benlysta_pc-cp-eng.php

Revlimid: Celgene Inc., in consultation with Health Canada, has informed Canadian healthcare providers of important information related to the safety of Revlimid® (lenalidomide) capsules.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2012/revlimid_pc-cp-eng.php

Summary Basis of Decision: A Summary Basis of Decision is available for Halaven.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2012_halaven_141946-eng.php

Draft Agenda: A draft agenda is available for the May 11, 2012 meeting of the Scientific Advisory Committee on Nonprescription Drugs (SAC-NPD).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-com/nonpres/sacnpd_draft_a_ccsmnl_ebauche_o_2012-05-11-eng.php

Summary Report: The Therapeutic Products Directorate (TPD) and the Biologics and Genetic Therapies Directorate (BGTD) are pleased to announce the release of the Summary Report of External Consultations on Phase II of the Summary Basis of Decision (SBD) project.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/sbd_ext_consult_sbd-eng.php

Summary Basis of Decision: A Summary Basis of Decision is available for Mozobil.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2012_mozobil_142638-eng.php

Summary Basis of Decision: A Summary Basis of Decision is available for Eliquis.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2012_eliquis_141873-eng.php

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

National Interest

Gazette I

Controlled Drugs and Substances Act: Proposed new classes of practitioners regulations are available.
http://www.gazette.gc.ca/rp-pr/p1/2012/2012-05-05/html/reg1-eng.html

Canadian Intellectual Property Office (CIPO)

Announcement: The Canada Business Center in Halifax, Nova Scotia is closing. Accordingly, as of May 15, 2012, there will no longer be a CIPO designated establishment in Halifax to which correspondence addressed to the Commissioner of Patents, the Registrar of Trade-marks, the Copyright Office or the Registrar of Topographies may be delivered in person.
http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr03495.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 2, No. 14 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-2-14

Patented Medicine Prices Review Board (PMPRB)

Revised Report: The PMPRB has released a revision to the NPDUIS analytical study, The Impact of Generic Entry on the Utilization of the Ingredient, originally published on September 30, 2011.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=283

Public Health Agency of Canada (PHAC)

Report: The 2012 Canadian Cancer Statistics report is available.
http://www.phac-aspc.gc.ca/cd-mc/cancer/ccs-scc-2012-eng.php

Canadian Institute for Health Information (CIHI)

Report: The report entitled, “Drug Expenditure in Canada, 1985 to 2011”, is available.
http://www.cihi.ca/CIHI-ext-portal/internet/en/Document/spending+and+health+workforce/spending/spending+by+category/RELEASE_03MAY12

Environment Canada

List: A comprehensive listing of substances that are subject to a Significant New Activity Notice was published on Environment Canada’s website.
http://www.ec.gc.ca/subsnouvelles-newsubs/default.asp?lang=En&n=0F76206A-1
 

 

~~~~~

HEADS UP - April 23, 2012

Notices of Compliance - April 16 - 20, 2012

• There were no new NOCs published during this week.

News from Health Canada

Health Canada

Announcement: The Honourable Leona Aglukkaq, Minister of Health, announced that the Economic Action Plan 2012 cuts red tape that currently delays access for Canadians to new over-the-counter (OTC) drugs.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2012/2012-57-eng.php

Biologics and Genetic Therapies Directorate (BGTD)

Updated List: The list of Canadian establishments that process and/or import semen for assisted conception has been updated.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/info-prod/don/can_semen_est-eta_can_sperme-eng.php

Therapeutic Products Directorate (TPD)

Advisory Committee: Updated information is available on the Scientific Advisory Committee on Non Prescription Drugs (SAC-NPD).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-com/nonpres/index-eng.php

Drug and Medical Device Recall Listings: The Drug and Medical Device Recall Listings have been updated.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/index-eng.php

Advisory Committee: Updated information is available on the Scientific Advisory Committee on Medical Devices Used in Cardiovascular Systems (SAC-MDUCS).
http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/sci-com/cardio/index-eng.php

Meeting: A Record of Decisions is available for the November 23, 2011 meeting between Health Canada and the Canadian Generic Pharmaceutical Association (CGPA).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/assoc/2011-11-23-eng.php

Meeting: A Record of Decisions is available for the October 5, 2011 meeting between Health Canada and Consumer Health Products Canada.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/assoc/2011-10-05-eng.php

Notice: Health Canada has issued a notice regarding the non-electronic Common Technical Document (eCTD) hybrid pilot.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ctd/ectd/notice_non_ectd_hybrid_pilot_avis-eng.php

Notice of Decision: A Notice of Decision is available for the Symplicity Renal Denervation System.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/md-im/nd_ad_2012_symplicity_189954-eng.php

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The Canadian Agency for Drugs and Technologies in Health has released the newsletter, CADTH Communiqué, Volume 2, No. 13.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-2-13

Report: CADTH has published the report, “SPECT-Related Technologies in Canada”.
http://www.cadth.ca/en/products/environmental-scanning/environmental-scans/environmental-scan-34

Patented Medicine Prices Review Board (PMPRB)

Newsletter: The PMPRB has released the April 2012 issue of its NEWSletter.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=282

National Association of Pharmacy Regulatory Authorities (NAPRA)

Newsletter: The Spring 2012 issue of the NAPRA Notes is available.
http://napra.ca/Content_Files/Files/NAPRA_Notes_Spring_2012_Final.pdf
 

 

~~~~~

HEADS UP - April 16, 2012

Notices of Compliance - April 9 - 13, 2012

• There were no new NOCs published during this week.

News from Health Canada

Natural Health Products Directorate (NHPD)

Meeting: Information is available from the Natural Health Products Program Advisory Committee meeting #11, held on November 21 and 22, 2011.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/activit/com/program-21-11-2011-eng.php

Therapeutic Products Directorate (TPD)

Health Care Professional Advisory

ACTOS: Takeda Canada Inc., in collaboration with Health Canada, would like to inform you of important safety information in regards to a potential risk of bladder cancer in patients treated with ACTOS (pioglitazone hydrochloride).
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2012/actos_3_hpc-cps-eng.php

Consumer Health Advisory

ACTOS: Health Canada has endorsed important safety information on ACTOS (pioglitazone hydrochloride).
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2012/actos_3_pc-cp-eng.php

Meeting: Meeting minutes are available for the July 26, 2011 meeting between Health Canada and the Compressed Gas Association (CGA).
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/activit/meet-reunion/cga-agm-20110726-eng.php

Meeting: Meeting minutes are available for the November 25, 2010 meeting between Health Canada and the Compressed Gas Association (CGA).
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/activit/meet-reunion/cga-agm-20101125-eng.php

Meeting: Meeting minutes are available for the April 20, 2010 meeting between Health Canada and the Compressed Gas Association (CGA).
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/activit/meet-reunion/cga-agm-20100420-eng.php

Notice of Decision: A Notice of Decision is available for Arzerra.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/nd_ad_2012_arzerra_128188-eng.php

Notice of Decision: A Notice of Decision is available for Edarbi.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/nd_ad_2012_edarbi_145305-eng.php

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

SOP: The Standard Operating Procedure: Using the Pharmaceutical Submission Executive Summary Template (PSEST) to Prepare Executive Summaries on Submissions for Marketing Authorization is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/proj/practice-pratique/grp_sop_bpe_pon-eng.php

Drug and Medical Device Recall Listings: The Drug and Medical Device Recall Listings have been updated.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/index-eng.php

National Interest

Federal Government

Chemical Substances Challenge: The Government of Canada is moving forward with consultations on the second phase of the Domestic Substances List Inventory Update.
http://www.ec.gc.ca/ese-ees/default.asp?lang=En&n=8F00FA44-1

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 2, No. 12 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-2-12

National Association of Pharmacy Regulatory Authorities (NAPRA)

Meeting: The proposed meeting of the National Drug Scheduling Advisory Committee for June 17-18, 2012 is cancelled. The next meeting of the Committee is scheduled for September 9-10, 2012.
http://napra.ca/pages/home/default.aspx
 

 

~~~~~

HEADS UP - April 9, 2012

Notices of Compliance - April 2 - 6, 2012

• There were no new NOCs published during this week.

News from Health Canada

Health Canada

Health Advisory: Health Canada is advising Canadians that Vita Health Products is conducting a voluntary recall of five lots of Compliments Extra Strength Acetaminophen Gelcaps 500mg (bottles of 120 gelcaps).
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_56-eng.php

Natural Health Products Directorate (NHPD)

Consultation: The Natural Health Products Directorate (NHPD) is seeking feedback on proposed revisions to the Probiotics Monograph and Abbreviated Labelling Standard (AbLS) for Live Microorganisms.
http://www.hc-sc.gc.ca/dhp-mps/consultation/natur/probio-eng.php

Consultation: The Natural Health Products Directorate (NHPD) is seeking feedback on proposed revisions to the marine oil monographs.
http://www.hc-sc.gc.ca/dhp-mps/consultation/natur/marin-eng.php

Consultation: The Natural Health Products Directorate (NHPD) is seeking feedback on proposed revisions to the enzyme abbreviated labelling standards (AbLS).
http://www.hc-sc.gc.ca/dhp-mps/consultation/natur/enzyme-eng.php

Report: A Status of Applications Quarterly Report - Quarter 3 (Fiscal year 2011-2012) is available.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/report-rapport/qar_tri_3-12-eng.php

Therapeutic Products Directorate (TPD)

Health Care Professional Advisory

EnTrust ICDs: Medtronic is advising that a small percentage of EnTrust ICDs may not meet expected longevity or provide at least three months of device operation between the Elective Replacement Indicator (ERI) and End of Life (EOL) due to a more-rapid-than-expected drop in battery voltage.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2012/medtronic_defib_hpc-cps-eng.php

Guidance: Health Canada is pleased to announce the release of the guidance document, Pre-market Evaluation of Hepatotoxicity in Health Products.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/hepatotox_guide_ld-eng.php

Newsletter: The Canadian Adverse Reaction Newsletter, Volume 22 - Issue 2 - April 2012 is available.
http://www.hc-sc.gc.ca/dhp-mps/medeff/bulletin/carn-bcei_v22n2-eng.php

Record of Decisions: A Record of Decisions is available for the October 24, 2011 meeting between Health Canada and Canada's Research-Based Pharmaceutical Companies (Rx&D).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/assoc/2011-10-24-eng.php

Revised List: Health Canada is pleased to announce changes to the Therapeutic Products Directorate's (TPD) List of Recognized Standards for medical devices.
http://www.hc-sc.gc.ca/dhp-mps/md-im/standards-normes/md_rec_stand_im_norm_lst-eng.php

Notice: Health Canada has issued a Notice regarding an additional Guidance on Transition from the Second to the Third Editions of the IEC 60601 Family of Standards on Health Canada's List of Recognized Standards.
http://www.hc-sc.gc.ca/dhp-mps/md-im/standards-normes/notice_iec_60601_avis-eng.php

National Interest

Gazette I

Canadian Environmental Protection Act, 1999: A notice has been issued requiring the preparation and implementation of pollution prevention plans with respect to bisphenol A in industrial effluents.
http://www.gazette.gc.ca/rp-pr/p1/2012/2012-04-14/html/sup-eng.html

Pharmaceutical Advertising Advisory Board (PAAB)

Newsletter: The April 2012 issue of the PAAB Views is available.
http://www.paab.ca/local/files/PAAB%20Views%20April%202012%20E.pdf

Patented Medicine Prices Review Board (PMPRB)

Consultation: The Board is seeking comments on proposed changes to the Compendium of Policies, Guidelines and Procedures.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=281
 

 

~~~~~

HEADS UP - March 26, 2012

Notices of Compliance - March 19 - 23, 2012

• There were no new NOCs published during this week.

News from Health Canada

Health Canada

Announcement: The Honourable Peter Kent, Minister of Environment, and the Honourable Leona Aglukkaq, Minister of Health, announced that the Government of Canada completed its preliminary assessment of triclosan under the Canadian Environmental Protection Act (CEPA), 1999.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2012/2012-48-eng.php

Natural Health Products Directorate (NHPD)

Form: An updated Electronic Product Licence Application form has been released.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/online-enligne/pla-dlmm-view-eng.php

Form: The Compendial from generated monograph Electronic Product Licence Application form has been released.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/online-enligne/pla-dlmm-co-view-eng.php

Electronic Submission Builder: An updated Electronic Submission Builder (eSB) for use with the new ePLA forms has been released.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/online-enligne/esb-gde-eng.php

Therapeutic Products Directorate (TPD)

Health Care Professional Advisory

GemStar Bolus Cord: Health Canada has endorsed important safety information on the GemStar Bolus Cord. Hospira, Inc. has received customer reports of bolus delivery failures when using the GemStar bolus cord.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2012/hospira_bolus_hpc-cps-eng.php

Sandoz Morphine Sulfate Injection USP 2mg/mL (1mL): Sandoz Canada is voluntarily initiating an immediate recall of a portion of lot CC2824 / exp. 2014-12 of Morphine Sulfate Injection USP 2 mg/mL, 1 mL ampoule (Sandoz Code: 5642).
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2012/sandoz_morphine_2_hpc-cps-eng.php

Meeting: A Record of Decisions is available for the November 16, 2011 meeting between Health Canada and Groupement provincial de l'industrie du médicament (GPIM).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/assoc/2011-11-16-eng.php

Document: A Quality System Framework for the Inspectorate Quality Management System (QM-0001) – 2012 is available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/activit/qsf-csq-eng.php

Guidance: A Guidance is available on the Classification of Observations for Inspection of Cells, Tissues and Organs Establishments (GUI-0101).
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/info-prod/cell/gui-0101_doc-eng.php

Summary Basis of Decision: A Summary Basis of Decision (SBD) is available for Incivek.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2012_incivek_142482-eng.php

Guidance Document: A Guidance on the Application for a Certificate of a Pharmaceutical Product (GUI-0024) is available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/directives/gui-0024_doc-eng.php

Revised Documents: Health Canada would like to inform sponsors that the following documents have been revised to reflect fees that are current as of April 1, 2012.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/announce-annonce/cr_notice_rc_avis-eng.php

Guidance: A Guidance on Drug Establishment Licences and Drug Establishment Licensing Fees (GUI-0002) is available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/directives/gui-0002-eng.php

Guidance Document: The Guidance Document entitled, “Fees for the Review of Drug Submissions and Applications”, is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/fees-frais/fee_frais_guide-eng.php

Form: A Drug Submission Fee Application Form is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/form/feef_fraisf-eng.php

Form Update: A Class IV Medical Device Licence Amendment Application Form - Address Update is available.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/md_licam_im_demmhom_cla4-eng.php

Form Update: A Class III Medical Device Licence Amendment Application Form - Address Update is available.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/md_licam_im_demmhom_cla3-eng.php

Form: A New Class IV Medical Device Licence Application Form is available.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/licapp_demhom_cla4-eng.php

Form: A New Class III Medical Device Licence Application Form is available.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/licapp_demhom_cla3-eng.php

Form: A New Class II Medical Device Licence Application Form is available.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/licapp_demhom_cla2-eng.php

Revised Guidance Document: Health Canada is pleased to announce the publication of the revisions to its Guidance Document: Patented Medicines (Notice of Compliance) Regulations.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/patmedbrev/pmreg3_mbreg3-eng.php

Update: The quarterly update to the Canada Vigilance Adverse Reaction Online Database has taken place.
http://www.hc-sc.gc.ca/dhp-mps/medeff/databasdon/index-eng.php

Expert Working Group: Information is available on the Canada Vigilance Expert Working Group.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advise-consult/cvewg-gecv/index-eng.php

Meeting: A meeting summary report is available for the October 19-20, 2011 meeting of the Expert Advisory Committee on the Vigilance of Health Products (EAC-VHP).
http://www.hc-sc.gc.ca/dhp-mps/medeff/advise-consult/eacvhp-ccevps/meet-reunion/oct-oct-11-eng.php

Draft Guidance: Health Canada is pleased to announce the release of the Draft Guidance Document: Preparation of Drug Regulatory Activities in Electronic Common Technical Document (eCTD) for a 60-day consultation period.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/draft_ebauche_prep_ectd_format-eng.php

Draft Canadian Module 1 Schema Version 2.1: Health Canada is pleased to announce the release of the draft Canadian Module 1 Schema Version 2.1 for a 30-day consultation period.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult_notice_draft_ectd_schema_ebauche_avis-eng.php

http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/notice_draft_ectd_schema_ebauche_avis-eng.php
(Consultation Document)

Draft Guidance: Health Canada is pleased to announce the release of the Draft Guidance for Industry: Creation of the Canadian Module 1 Backbone for a 30 day consultation period.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult_draft_ebauche_ectd_mod1_guide-ld-eng.php

http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/draft_ebauche_ectd_mod1_guide-ld-eng.php
(Consultation Document)

Drug and Medical Device Recall Listings: The Drug and Medical Device Recall Listings have been updated.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/index-eng.php

National Interest

Federal Government

Chemical Substances Challenge: The preliminary assessment report for triclosan was published for a 60-day public comment period.
http://www.chemicalsubstanceschimiques.gc.ca/plan/approach-approche/triclosan-eng.php
 
Gazette I

Canadian Environmental Protection Act, 1999: Publication after screening assessment of a substance — Phenol, 5-chloro-2-(2,4-dichlorophenoxy)- (triclosan), CAS No. 3380-34-5 — specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999) is available.
http://www.gazette.gc.ca/rp-pr/p1/2012/2012-03-31/html/index-eng.html

Advertising Standards Canada (ASC)

Meeting: The Advertising Standards Canada Annual General Meeting Breakfast Program will take place on May 3, 2012.
http://www.adstandards.com/en/Events/201204AGMToronto.asp

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 2, No. 10 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-2-10

Health Council of Canada (HCC)

Report: The Senate Committee on Social Affairs, Science and Technology has released the report entitled, “Time for Transformative Change: A Review of the 2004 Health Accord”.
http://www.healthcouncilcanada.ca/cnt_nws.php?id=35

 

 

~~~~~

 

HEADS UP -March 26, 2012

Notices of Compliance- March 19 - 23, 2012

• There were no new NOCs published during this week.

News from Health Canada

Health Canada

Announcement: The Honourable Peter Kent, Minister of Environment, and the Honourable Leona Aglukkaq, Minister of Health, announced that the Government of Canada completed its preliminary assessment of triclosan under the Canadian Environmental Protection Act (CEPA), 1999.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2012/2012-48-eng.php

Natural Health Products Directorate (NHPD)

Form: An updated Electronic Product Licence Application form has been released.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/online-enligne/pla-dlmm-view-eng.php

Form: The Compendial from generated monograph Electronic Product Licence Application form has been released.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/online-enligne/pla-dlmm-co-view-eng.php

Electronic Submission Builder: An updated Electronic Submission Builder (eSB) for use with the new ePLA forms has been released.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/online-enligne/esb-gde-eng.php

Therapeutic Products Directorate (TPD)

Health Care Professional Advisory

GemStar Bolus Cord: Health Canada has endorsed important safety information on the GemStar Bolus Cord. Hospira, Inc. has received customer reports of bolus delivery failures when using the GemStar bolus cord.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2012/hospira_bolus_hpc-cps-eng.php

Sandoz Morphine Sulfate Injection USP 2mg/mL (1mL): Sandoz Canada is voluntarily initiating an immediate recall of a portion of lot CC2824 / exp. 2014-12 of Morphine Sulfate Injection USP 2 mg/mL, 1 mL ampoule (Sandoz Code: 5642).
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2012/sandoz_morphine_2_hpc-cps-eng.php

Meeting: A Record of Decisions is available for the November 16, 2011 meeting between Health Canada and Groupement provincial de l'industrie du médicament (GPIM).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/assoc/2011-11-16-eng.php

Document: A Quality System Framework for the Inspectorate Quality Management System (QM-0001) – 2012 is available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/activit/qsf-csq-eng.php

Guidance: A Guidance is available on the Classification of Observations for Inspection of Cells, Tissues and Organs Establishments (GUI-0101).
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/info-prod/cell/gui-0101_doc-eng.php

Summary Basis of Decision: A Summary Basis of Decision (SBD) is available for Incivek.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2012_incivek_142482-eng.php

Guidance Document: A Guidance on the Application for a Certificate of a Pharmaceutical Product (GUI-0024) is available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/directives/gui-0024_doc-eng.php

Revised Documents: Health Canada would like to inform sponsors that the following documents have been revised to reflect fees that are current as of April 1, 2012.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/announce-annonce/cr_notice_rc_avis-eng.php

Guidance: A Guidance on Drug Establishment Licences and Drug Establishment Licensing Fees (GUI-0002) is available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/directives/gui-0002-eng.php

Guidance Document: The Guidance Document entitled, “Fees for the Review of Drug Submissions and Applications”, is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/fees-frais/fee_frais_guide-eng.php

Form: A Drug Submission Fee Application Form is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/form/feef_fraisf-eng.php

Form Update: A Class IV Medical Device Licence Amendment Application Form - Address Update is available.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/md_licam_im_demmhom_cla4-eng.php

Form Update: A Class III Medical Device Licence Amendment Application Form - Address Update is available.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/md_licam_im_demmhom_cla3-eng.php

Form: A New Class IV Medical Device Licence Application Form is available.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/licapp_demhom_cla4-eng.php

Form: A New Class III Medical Device Licence Application Form is available.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/licapp_demhom_cla3-eng.php

Form: A New Class II Medical Device Licence Application Form is available.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/licapp_demhom_cla2-eng.php

Revised Guidance Document: Health Canada is pleased to announce the publication of the revisions to its Guidance Document: Patented Medicines (Notice of Compliance) Regulations.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/patmedbrev/pmreg3_mbreg3-eng.php

Update: The quarterly update to the Canada Vigilance Adverse Reaction Online Database has taken place.
http://www.hc-sc.gc.ca/dhp-mps/medeff/databasdon/index-eng.php

Expert Working Group: Information is available on the Canada Vigilance Expert Working Group.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advise-consult/cvewg-gecv/index-eng.php

Meeting: A meeting summary report is available for the October 19-20, 2011 meeting of the Expert Advisory Committee on the Vigilance of Health Products (EAC-VHP).
http://www.hc-sc.gc.ca/dhp-mps/medeff/advise-consult/eacvhp-ccevps/meet-reunion/oct-oct-11-eng.php

Draft Guidance: Health Canada is pleased to announce the release of the Draft Guidance Document: Preparation of Drug Regulatory Activities in Electronic Common Technical Document (eCTD) for a 60-day consultation period.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/draft_ebauche_prep_ectd_format-eng.php

Draft Canadian Module 1 Schema Version 2.1: Health Canada is pleased to announce the release of the draft Canadian Module 1 Schema Version 2.1 for a 30-day consultation period.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult_notice_draft_ectd_schema_ebauche_avis-eng.php

http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/notice_draft_ectd_schema_ebauche_avis-eng.php
(Consultation Document)

Draft Guidance: Health Canada is pleased to announce the release of the Draft Guidance for Industry: Creation of the Canadian Module 1 Backbone for a 30 day consultation period.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult_draft_ebauche_ectd_mod1_guide-ld-eng.php

http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/draft_ebauche_ectd_mod1_guide-ld-eng.php
(Consultation Document)

Drug and Medical Device Recall Listings: The Drug and Medical Device Recall Listings have been updated.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/index-eng.php

National Interest

Federal Government

Chemical Substances Challenge: The preliminary assessment report for triclosan was published for a 60-day public comment period.
http://www.chemicalsubstanceschimiques.gc.ca/plan/approach-approche/triclosan-eng.php
 
Gazette I

Canadian Environmental Protection Act, 1999: Publication after screening assessment of a substance — Phenol, 5-chloro-2-(2,4-dichlorophenoxy)- (triclosan), CAS No. 3380-34-5 — specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999) is available.
http://www.gazette.gc.ca/rp-pr/p1/2012/2012-03-31/html/index-eng.html

Advertising Standards Canada (ASC)

Meeting: The Advertising Standards Canada Annual General Meeting Breakfast Program will take place on May 3, 2012.
http://www.adstandards.com/en/Events/201204AGMToronto.asp

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 2, No. 10 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-2-10

Health Council of Canada (HCC)

Report: The Senate Committee on Social Affairs, Science and Technology has released the report entitled, “Time for Transformative Change: A Review of the 2004 Health Accord”.
http://www.healthcouncilcanada.ca/cnt_nws.php?id=35
 

 

~~~~~

 

HEADS UP - March 19, 2012

Notices of Compliance - March 12 - 16, 2012

• Aloxi (palonosetron hydrochloride) was approved as an anti-emetic (5-HT3 Receptor Antagonist) on 2012-03-14.

News from Health Canada

Health Canada

Voluntary Recall: Following the Health Canada March 21, 2012 Notice to Hospitals and Notice to Healthcare Professionals, Health Canada is advising Canadians that Sandoz Canada Inc. will be voluntarily recalling a portion of one lot of 2mg/mL (1mL) Morphine Sulfate Injection (Lot CC2824 exp. 2014-12) from the Canadian market.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_45-eng.php

Biologics, Radiopharmaceuticals & Genetic Therapies Directorate (BGTD)

Meeting: Meeting minutes are available for the November 16, 2011 meeting between Health Canada and BIOTECanada.
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/activit/meet-reunion/biotecanada-mm-crr-2011-11-16-eng.php

Therapeutic Products Directorate (TPD)

Report: A Summary Report of Inspections of Clinical Trials conducted from April 2004 to March 2011 is available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/clini-pract-prat/report-rapport/2004-2011-eng.php

Guidance: The Guidance on Medical Device Establishment Licensing and Medical Device Establishment Licence Fees (GUI-0016) has been updated.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/directives/gui-0016-eng.php

Notice of Decision: A Notice of Decision is available for Fampyra.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/nd_ad_2012_fampyra_132859-eng.php

Notice: Health Canada is pleased to announce the release of the revised Post-Notice of Compliance (NOC) Changes: Level III form in fillable, Portable Document Format (PDF). This revision is to support the new Post-Notice of Compliance (NOC) Changes - Quality Guidance Appendix 1 for Human Pharmaceuticals that became effective October 17, 2011.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/postnoc_change_apresac/noc_pn_leviii_notice_form_ac_sa_niviii_avis-eng.php

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/form/noc_pn_leviii_form_ac_sa_niviii-eng.php
(Post-Notice of Compliance (NOC) Changes: Level III Form)

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

National Interest

Federal Government

Chemical Substances Challenge: A final Order adding four substances in Batch 8 of the Challenge to Schedule 1 to the Canadian Environmental Protection Act, 1999 has been published.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-8/index-eng.php
 
Gazette I

Canada Consumer Product Safety Act: Administrative Monetary Penalties (Consumer Products) Regulations are available.
http://www.gazette.gc.ca/rp-pr/p1/2012/2012-03-24/html/reg3-eng.html

Gazette II

Food and Drug Regulations: Regulations amending the Food and Drug Regulations (1571 — Food Additives) are available.
http://www.gazette.gc.ca/rp-pr/p2/2012/2012-03-28/html/sor-dors44-eng.html

Canadian Environmental Protection Act, 1999: An Order adding toxic substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 is available.
http://www.gazette.gc.ca/rp-pr/p2/2012/2012-03-28/html/sor-dors40-eng.html
 

 

~~~~~

 

HEADS UP - March 12, 2012

Notices of Compliance- March 5 - 9, 2012

• Edarbi (azilsartan medoxomil) was approved as an Angiotensin II AT1 Receptor Blocker on 2012-03-09.

• Arzerra (ofatumumab) was approved as an Antineoplastic Agent on   2012-03-09.

News from Health Canada

Health Canada

Health Advisory: Health Canada is informing health professionals and the public that the prescription drugs finasteride and dutasteride may be associated with an increased risk of developing a serious form of prostate cancer known as high-grade prostate cancer.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_38-eng.php

Voluntary Recall: Health Canada is informing Canadians that Apotex Incorporated is conducting a voluntary recall of one lot of Apo-Ramipril 5mg Capsules used to treat hypertension (high blood pressure). The recall of Lot JR2178 was made to retail outlets across Canada.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_37-eng.php

Biologics, Radiopharmaceuticals & Genetic Therapies Directorate (BGTD)

Record of Meeting: A Record of Meeting is available for the September 29, 2011 meeting of the Expert Advisory Committee on Blood Regulations.
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/activit/com/eacbr-ccers/_meet-reunion/mm-crr_2011-09-29-eng.php

Therapeutic Products Directorate (TPD)

Notice to Hospitals

2mg/mL (1mL) Sandoz Morphine Sulfate Injection USP: Some boxes of 2mg/mL (1mL) Sandoz Morphine Sulfate Injection USP may contain ampoules labelled as Isoproterenol Hydrochloride Injection in addition to ampoules labelled as containing morphine.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2012/sandoz_morphine_nth-aah-eng.php

Health Care Professional Advisory

Pradax: Boehringer Ingelheim (Canada) Ltd., in consultation with Health Canada, would like to inform you of important new recommendations which have been added to the Product Monograph for Pradax® (dabigatran etexilate).
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2012/pradax_hpc-cps-eng.php

Morphine Sulfate Injection USP: Health Canada is urgently informing healthcare professionals that it has been advised by Sandoz Canada Inc. that one package of 2mg/mL (1mL) Morphine Sulfate Injection USP has been found to contain ampoules labelled as 0.2 mg/mL (1mL) Isoproterenol Hydrochloride Injection in addition to ampoules labelled as containing morphine.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2012/sandoz_morphine_hpc-cps-eng.php

Consumer Health Advisory

Pradax: Health Canada has issued an update to Pradax® (dabigatran etexilate) labelling regarding assessment of kidney function and use in patients with certain types of heart valve disease or artificial heart valves.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2012/pradax_pc-cp-eng.php

Form: A Post-Notice of Compliance (NOC) Changes: Level III Form is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/form/noc_pn_leviii_form_ac_sa_niviii-eng.php

Record of Decisions: A Record of Decisions is available for the September 28, 2011 meeting between Health Canada and the Canadian Pharmacists Association.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/assoc/2011-09-28-eng.php

Update: Updated information is available on the Scientific Advisory Committee on Respiratory and Allergy Therapies.

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-com/resp_allerg/sacrat_ccstrta_m_bio-eng.php
(Membership List and Biographies – Updated)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-com/resp_allerg/sacrat_ccstrta_ai-eng.php
(Summary of Expertise, Experience and Affiliations and Interest – Updated)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-com/resp_allerg/sacrat_a_ccstrta_o_2012-03-14-eng.php
(Draft Meeting Agenda, March 14, 2012)

Guidance Document: The Guidance Document entitled, “Medical Device Licence Renewal and Fees for the Right to Sell Licensed Medical Devices”, is available.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/md_licren_mm_homren-eng.php

Guidance Document: Health Canada has issued the Guidance Document entitled, “Fees for the Review of Medical Device Licence Applications”.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/guidedoc_feesmd_docorient_fraisim-eng.php

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

Drug and Medical Device Recall Listings: The Drug and Medical Device Recall Listings have been updated.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/index-eng.php

National Interest

Advertising Standards Canada (ASC)

Report: Advertising Standards Canada (ASC) released its Ad Complaints Report - 2011 Year in Review. The Report provides information about consumers' complaints submitted to ASC in 2011 for review under the Canadian Code of Advertising Standards.
http://www.adstandards.com/en/MediaAndEvents/2011complaintsReportPressRelease.aspx

Canadian Intellectual Property Office (CIPO)

Announcement: Improvements have been made to the online Electronic Payment of Patent Maintenance Fees system.
http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr03436.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 2, No. 9 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-2-9

Patented Medicine Prices Review Board (PMPRB)

Voluntary Compliance Undertaking: The Chairperson of the Board accepted a Voluntary Compliance Undertaking (VCU) for Precedex.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=280

Updated Guide: The Patentee’s Guide to Reporting has been updated.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=279
 

 

~~~~~

 

HEADS UP - February 20, 2012

Notices of Compliance - February 13 - 17, 2012

• Zelboraf (vemurafenib) was approved as a protein kinase inhibitor on 2012-02-15.

News from Health Canada

Health Canada

Announcement: Canada's Environment Minister, the Honourable Peter Kent, announced that the Government of Canada has decided siloxane D5 is not harmful to the environment.
http://www.ec.gc.ca/default.asp?lang=En&n=714D9AAE-1&news=97F8EE9B-003B-4B70-8F40-DE3432B3A995

Health Advisory: Health Canada is informing Canadians of an ongoing safety review of the multiple sclerosis (MS) drug, Gilenya (the brand name for fingolimod). The review was initiated following reports of serious international adverse events.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_28-eng.php

Health Advisory: Health Canada has identified additional web sites selling MMS Sodium Chlorite Solution which is not authorized for oral consumption by humans.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_27-eng.php

Health Advisory: Health Canada seized a variety of Stiff4Ever and PurePillz products from The Love Shop retail outlets located in Ontario. These products are unauthorized drugs and are considered potentially dangerous to the health and safety of Canadians.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_26-eng.php

Biologics, Radiopharmaceuticals & Genetic Therapies Directorate (BGTD)

Report: The Biologics and Genetic Therapies Directorate Drug Submission Performance Quarterly Report; October – December 2011 has been published.
www.jptcp.com/files/bgtd_dpbtg_11_oct_dec_eng.pdf

Therapeutic Products Directorate (TPD)

Report: The Therapeutic Products Directorate Drug Submission Performance Quarterly Report; October – December 2011 has been published.
www.jptcp.com/files/tpd_dpt_11_oct_dec_eng.pdf

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

National Interest

Federal Government

Chemical Substances Challenge: A Notice concerning the conclusion for D5, a substance in Batch 2 of the Challenge, was published.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-2/index-eng.php

Chemical Substances Plan: The new Chemicals Management Plan (CMP) eSubmissions online system is now available for completing the Notice (mandatory survey) under section 71 of the Canadian Environmental Protection Act, 1999 with respect to certain aromatic amines and aromatic azo- and benzidine-based substances.
http://www.chemicalsubstanceschimiques.gc.ca/plan/approach-approche/azo_benzidine-eng.php

Gazette I

Canadian Environmental Protection Act, 1999: The final decision on the screening assessment of a substance — Decamethylcyclopentasiloxane (D5), CAS No. 541-02-6 — specified on the Domestic Substances List (subsection 77(6) of the Canadian Environmental Protection Act, 1999) has been published.
http://www.gazette.gc.ca/rp-pr/p1/2012/2012-02-25/html/index-eng.html

Gazette II

Food and Drug Regulations: Regulations amending the Food and Drug Regulations (1593 — Clinical Trials — Miscellaneous Program) are available.
http://www.gazette.gc.ca/rp-pr/p2/2012/2012-02-29/html/sor-dors16-eng.html

Patented Medicine Prices Review Board (PMPRB)

Survey: The Patented Medicine Prices Review Board (PMPRB) survey of stakeholders is available.
http://97.ca/ekos/cwx.cgi?EN:01612:KQHAHULJQV
 

 

~~~~~

 

HEADS UP - February 13, 2012

Notices of Compliance - February 6 – 10, 2012

• Fampyra (fampridine) was approved as a potassium channel blocker on 2012-02-10.

• Toviaz (fesoterodine fumarate) was approved as an anticholinergic; antispasmodic agent on 2012-02-09.

News from Health Canada

Health Canada

Health Advisory: Health Canada is informing Canadians of a possible association between the use of prescription stomach antacids known as proton pump inhibitors (PPIs) and an increased risk of Clostridium difficile-associated diarrhea (CDAD).
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_23-eng.php

Natural Health Products Directorate (NHPD)

Report: The NHPD has released its Status of Applications Quarterly Report,
Quarter 3.
www.jptcp.com/files/2011_2012_Q3_Report_Eng.pdf

Therapeutic Products Directorate (TPD)

Summary Basis of Decision: A Summary Basis of Decision (SBD) has been issued for Saphris.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2012_saphris_127427-eng.php

National Interest

Gazette I

Health Canada Notice: Health Canada has issued a notice amending Health Canada’s Drug Master Files and Certificate of a Pharmaceutical Product fees.
http://www.gazette.gc.ca/rp-pr/p1/2012/2012-02-18/html/index-eng.html

Canadian Intellectual Property Office (CIPO)

Announcement: The Canadian Intellectual Property Office (CIPO) has issued Official Correspondence Procedures.
http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr03422.html
 
Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 2, No. 6 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-2-6

 

 

~~~~~

 

HEADS UP - January 30, 2012

Notices of Compliance - January 23 - 27, 2012

• There were no new NOCs published this week.

News from Health Canada

Therapeutic Products Directorate (TPD)

Notice to Hospitals

Non-Invasive Ventilation Devices: Health Canada has issued important safety information on Non-Invasive Ventilation Devices.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2012/ventilation_nth-aah-eng.php

Drug and Medical Device Recall Listings: The Drug and Medical Device Recall Listings have been updated.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/index-eng.php

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

Summary Basis of Decision: A Summary Basis of Decision (SBD) is available for Ruby-Fill.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2012_rubyfill_138823-eng.php

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

Consultation: A draft Issues in Emerging Health Technologies bulletin on the topic of thermography for breast cancer diagnosis is available for feedback from all interested stakeholders.
http://www.cadth.ca/en/media-centre/2012/3-call-for-feedback

Consultation: Draft science reports for the project New Oral Anticoagulants for the Prevention of Thromboembolic Events in Patients with Atrial Fibrillation are available for feedback.
http://www.cadth.ca/en/media-centre/2012/2-call-for-feedback

Newsletter: The CADTH Communiqué, Volume 2, No. 4 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-2-4
 

 

~~~~~

 

HEADS UP - January 23, 2012

Notices of Compliance - January 16 - 20, 2012

• There were no new NOCs published this week.

News from Health Canada

Therapeutic Products Directorate (TPD)

Health Care Professional Advisory

Celexa (citalopram): Lundbeck Canada, in collaboration with Health Canada, would like to inform you that the antidepressant Celexa® (citalopram hydrobromide; also marketed as generics), should no longer be used at doses greater than 40 mg per day due to study results indicating a dose-dependent potential for QT prolongation. Previously, the Celexa® (citalopram hydrobromide) Canadian Product Monograph stated that certain patients may require 60 mg per day.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2012/celexa_2_hpc-cps-eng.php

Velcade (bortezomib): Janssen Inc., in consultation with Health Canada, would like to alert you to the risk of fatal outcome associated with the inadvertent intrathecal administration of the antineoplastic drug VELCADE® (bortezomib).
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2012/velcade_hpc-cps-eng.php

Consumer Health Advisory

Celexa (citalopram): Lundbeck Canada, in collaboration with Health Canada, would like to inform patients and healthcare professionals that the antidepressant Celexa® (citalopram hydrobromide; also marketed as generics) should not be taken at doses of more than 40 mg a day. Higher doses can cause abnormal heart rhythms, based on the results of a research study.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2012/celexa_2_pc-cp-eng.php

Notice to Hospitals

Doribax (doripenem for injection): Janssen Inc., in consultation with Health Canada, would like to inform you of new safety information regarding the use of DORIBAX® in the treatment of ventilator-associated pneumonia (VAP).
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2012/doribax_nth-aah-eng.php

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

Drug Recall Listings: The Drug Recall Listings have been updated.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/index-eng.php

National Interest

Gazette I

Food and Drugs Act: Regulations amending the Food and Drug Regulations have been published in Gazette I.
http://www.gazette.gc.ca/rp-pr/p1/2012/2012-01-28/html/notice-avis-eng.html#d108

Advertising Standards Canada (ASC)

Newsletter: The winter 2012 ASC newsletter is available.
http://www.adstandards.com/en/ASCLibrary/newsletters/winter2012/newsletter_ASCNews.aspx

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 2, No. 3 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-2-3

Patient Input: Information is available on two (3) drugs (Actemra, Mozabil, Botox) added to the Call for Patient Input for the Common Drug Review Process.
http://www.cadth.ca/en/products/cdr/patient-group-input

Patented Medicine Prices Review Board (PMPRB)

Newsletter: The January 2012 issue of the PMPRB newsletter is available.
http://www.pmprb-cepmb.gc.ca/english/View.asp?x=287

Web Application: On January 31, 2012, the PMPRB launched its user-friendly Web application for New Patented Medicines Reported to the PMPRB.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=273

Voluntary Compliance Undertaking: The Chairperson of the Board accepted a Voluntary Compliance Undertaking (VCU) for Thalomid.
http://www.pmprb-cepmb.gc.ca/english/View.asp?x=1605&mp=271
 

 

~~~~~

 

HEADS UP - January 16, 2012

Notices of Compliance - January 9 - 13, 2012

• Caprelsa (ZD6474, Vandetanib) was approved as a receptor tyrosine kinase inhibitor on January 12, 2012.

News from Health Canada

Health Canada

Foreign Product Alerts: The following Foreign Product Alerts are available.

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2012/2012-11-eng.php
(17 weight loss products)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2012/2012-12-eng.php
(Athri-Eze, Sear Heang Tienchi Tu Chung Wan, Wiku Jahe Kencur (Akur Mujarab), Cap Wijaya Kusuma (An Ki It))

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2012/2012-18-eng.php
(Ying Da Wang tablets)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2012/2012-14-eng.php
(Get Stiff, Maxi Mize)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2012/2012-17-eng.php
(Uprizing 2.0)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2012/2012-16-eng.php
(Slimina weightloss capsules, S-shape slim capsules)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2012/2012-15-eng.php
([LuShenPai] Specific Hou Ton Qing , [AA] Pe Min Kan Wan)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2012/2012-13-eng.php
(Cardiotium - Paidusu - SlimEasy Herbs Capsule - Tianran Zuanshi Xianweisu)

Health Advisory: Further to previous communications, Health Canada is advising Canadians that two additional Male and Female Harmony retail stores that were selling unauthorized health products have been identified.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_09-eng.php

Health Advisory: Health Canada is informing Canadians that the review of Champix is now complete and the label has been updated with new information with respect to cardiovascular safety.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_07-eng.php

Health Advisory: Health Canada has issued an important reminder about Weight-loss Health Products.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_06-eng.php

Therapeutic Products Directorate (TPD)

Notice to Hospitals

Duet TRS Loading Units: Covidien (formerly United States Surgical, a division of Tyco Healthcare Group, L. P.) is conducting a voluntary Recall of all production lots for the Duet TRS™ Universal Straight and Articulating Single Use Loading Units (SULU) with respect to the use of this product family in the thoracic cavity.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2012/covidien_nth-aah-eng.php

Health Care Professional Advisory

Rasilez and Rasilez HCT: Novartis Pharmaceuticals Canada Inc., in collaboration with Health Canada, would like to inform you about important new safety information for aliskiren-containing products following interim results review from the Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE). Interim results indicated a higher incidence of non-fatal strokes, renal complications (end stage renal disease and renal death), hyperkalemia and hypotension in aliskiren-treated patients.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2012/rasilez_hpc-cps-eng.php

Consumer Health Advisory

Rasilez and Rasilez HCT: Health Canada has endorsed important safety information on Rasilez (aliskiren) and Rasilez HCT (aliskiren/hydrochlorothiazide).
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2012/rasilez_pc-cp-eng.php

Summary Basis of Decision: A Summary Basis of Decision (SBD) is available for the Edwards Sapien Transcatheter Heart Valve.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/md-im/sbd_smd_2011-sapien_thv_176966-eng.php

Notice of Decision: A Notice of Decision is available for the Onbrez Breezhaler.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/nd_ad_2012_onbrez_breezhaler_143984-eng.php

Notice of Decision: A Notice of Decision is available for Resotran.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/nd_ad_2012_resotran_141157-eng.php

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

National Interest

Gazette I

Food and Drug Regulations/Controlled Drugs and Substances Act:   Proposed amendments to Schedule III to the Controlled Drugs and Substances Act and the Schedule to Part J of the Food and Drug Regulations are available.
http://www.gazette.gc.ca/rp-pr/p1/2012/2012-01-21/html/index-eng.html

Pharmaceutical Advertising Advisory Board (PAAB)

Newsletter: The January 2012 issue of the PAAB Views is available.
http://www.paab.ca/local/files/PAAB%20Views%20January%202012%20E.pdf

Open House: The PAAB Open House will be held on February 1, 2012.
http://www.paab.ca/en/what_is_new/

PAAB Code Review & Survey: The PAAB Code Review 2012 & survey are available.
http://paab.ca/en/paab_code/paab_code_review/

Patented Medicine Prices Review Board (PMPRB)

Voluntary Compliance Undertaking: The Chairperson of the Board accepted a Voluntary Compliance Undertaking (VCU) for Dovobet.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=272
 

 

~~~~~

 

HEADS UP - January 9 , 2012

Notices of Compliance - January 2 - 6, 2012

• There were no new NOCs published this week.

News from Health Canada

Health Canada

News Release: The Honourable Leona Aglukkaq, Minister of Health, announced the creation of a national advisory committee on Traditional Chinese Medicines (TCMs).
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2012/2012-03-eng.php

Advisory: Health Canada is advising Canadians that Novartis Consumer Health Inc’s U.S. recall is now being extended to Canada. According to Novartis Consumer Health Canada Inc, the Canadian recall includes all lots (expiration dates of December 20, 2014 and earlier) for over-the-counter products, Excedrin Extra Strength Caplets and Excedrin Tension Headache Caplets.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_04-eng.php

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 2, No. 2 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-2-2

Report: The final reports on optimal Warfarin management are available.
http://www.cadth.ca/en/products/optimal-use/warfarin-management/reports

Patient Input: Information is available on one (1) drug (Resotran) added to the Call for Patient Input for the Common Drug Review Process.
http://www.cadth.ca/en/products/cdr/patient-group-input

Public Health Agency of Canada

Update: An update is available on the human papillomavirus (HPV) vaccine.
http://www.phac-aspc.gc.ca/publicat/ccdr-rmtc/11vol37/acs-dcc-8/index-eng.php
 

 

~~~~~

 

HEADS UP - January 2, 2012

Notices of Compliance - December 26 - 30, 2011

• There were no new NOCs published this week.

News from Health Canada

Therapeutic Products Directorate (TPD)

Consultation: A revised guidance document: Considerations for Inclusion of Women in Clinical Trials and Analysis of Data by Sex has been released.
http://www.hc-sc.gc.ca/dhp-mps/consultation/biolog/draft_iwct_ebauche_ifec/index-eng.php

http://www.hc-sc.gc.ca/dhp-mps/consultation/biolog/draft_iwct_ebauche_ifec/lett-eng.php
(Consultation Document)

http://www.hc-sc.gc.ca/dhp-mps/consultation/biolog/draft_iwct_ebauche_ifec/form-eng.php
(Forms for Comment)

Summary Basis of Decision: A Summary Basis of Decision is available for Trajenta.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2011_trajenta_140881-eng.php

Newsletter: The January 2012 edition of the Canadian Adverse Reaction Newsletter, Volume 22 - Issue 1 is available.
http://www.hc-sc.gc.ca/dhp-mps/medeff/bulletin/carn-bcei_v22n1-eng.php

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 2, No. 1 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-2-1

Screening: CADTH will be hosting a film screening and group discussion on Sunday, January 29, 2012. The goal of this focus group is to obtain feedback from people living with type 2 diabetes on our animated film about blood glucose test strips.
http://www.cadth.ca/en/media-centre/2012/looking-for-people-with-type-2-diabetes-to-critique

Patented Medicine Prices Review Board (PMPRB)

Report: Revisions have been made to the National Prescription Drug Utilization System (NPDUIS) analytical report entitled: Wholesale Up-charge Policies of Canada’s Public Drug Plans originally posted December 29, 2011.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=271

National Association of Pharmacy Regulatory Authorities (NAPRA)

Meeting: The proposed meeting of the National Drug Scheduling Advisory Committee for March 4-5, 2012 is cancelled. The next meeting of the Committee is scheduled for June 17-18, 2012. The deadline to receive submissions for a drug scheduling application for this meeting is by end of day Wednesday, April 18, 2012.
http://napra.ca/pages/Schedules/meeting_schedule.aspx
 

 

~~~~~

 

HEADS UP - Dec 30, 2011

Notices of Compliance - December 19-23, 2011

• There were no new NOCs published this week.

News from Health Canada

Health Canada

Advisory: Health Canada is advising Canadians that Vita Health's product, "Compliments Muscle and Back Pain Relief Regular Strength" contains a significant labelling error in the French dosing directions that may pose serious risks to children (less than 12 years of age), if taken by them.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_178-eng.php

Therapeutic Products Directorate (TPD)

Summary Basis of Decision: A Summary Basis of Decision is available for Samsca.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2011_samsca_139413-eng.php

Update: The quarterly update to the Canada Vigilance Adverse Reaction Online Database has taken place.
http://www.hc-sc.gc.ca/dhp-mps/medeff/databasdon/index-eng.php

Summary Basis of Decision: A Summary Basis of Decision is available for Benlysta.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2011_benlysta_137699-eng.php

Summary Basis of Decision: A Summary Basis of Decision is available for Victrelis.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2011_victrelis_141556-eng.php

National Interest

Gazette II

Food and Drugs Act: Regulations amending The Medical Devices Regulations (1667 — Miscellaneous Program) have been published in Gazette II.
http://www.gazette.gc.ca/rp-pr/p2/2012/2012-01-04/html/sor-dors322-eng.html

Patented Medicine Prices Review Board (PMPRB)

Report: The National Prescription Drug Utilization System (NPDUIS) has released a new analytical report entitled: Wholesale Up-charge Policies of Canada’s Public Drug Plans.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=270

Notice: The Patented Medicine Prices Review Board (the Board) has published for comment its proposed revised Rules of Practice and Procedure pertaining to the hearing process.
http://www.pmprb-cepmb.gc.ca/english/View.asp?x=1499&mp=400

National Association of Pharmacy Regulatory Authorities (NAPRA)

Information Update: Health Canada is informing Canadians of Pfizer Canada's instruction for the correct use of EpiPen and EpiPen Jr., particularly the correct way to remove the blue safety caps. According to the company, it is important that the blue safety cap be removed by pulling the cap straight up while the device is held with the orange tip pointing downward. Pfizer states that inappropriate removal of the blue safety cap may prevent the device from working properly and potentially result in failure to deliver the drug.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_176-eng.php

Public Health Agency of Canada

Information Update: In recent weeks, a new variant of the influenza A H3N2 virus, now referred to as A(H3N2)v has been identified in the United States. A(H3N2)v is a swine origin influenza virus which also has genes from birds and humans, and usually infects pigs.
http://www.phac-aspc.gc.ca/influenza/h3n2-eng.php
 

 

~~~~~

 

HEADS UP - December 19, 2011

Notices of Compliance - December 12-16, 2011

• Eliquis (apixaban) was approved as an anticoagulant on December 16, 2011.

• Halaven (eribulin mesylate) was approved as an antineoplastic on December 14, 2011.

News from Health Canada

Health Canada

Advisory: In light of the recent company decision (Novartis press release) to stop a multi-national clinical trial known as the Altitude study, Health Canada is informing Canadians that it is reviewing the safety of the prescription blood-pressure drug Rasilez (the brand name for aliskiren).
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_175-eng.php

Advisory: Health Canada is informing Canadians and Canadian healthcare practitioners that Smiths Medical is conducting a North American voluntary recall of certain lot numbers (see below) of Bivona® Neonatal, Pediatric and Flextend Tracheostomy Tubes.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_177-eng.php

Therapeutic Products Directorate (TPD)

Health Care Professional Advisory

EpiPen and EpiPen Jr Auto Injector: Pfizer Canada Inc. (distributor of EpiPen for Dey Pharma, L.P.) in collaboration with Health Canada would like to advise you of the correct method to remove the blue safety release and of the importance of following the instructions for use of EpiPen (0.3 mg epinephrine auto-injector) and EpiPen Jr (0.15 mg epinephrine auto-injector).  It has recently come to our attention that removal of the blue safety release the wrong way, by pulling it sideways or bending and twisting it off (in a manner inconsistent with the current product labelling), may cause the auto-injector to spontaneously activate or not work correctly, resulting in failure to deliver the drug.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/epipen_hpc-cps-eng.php

Consumer Health Advisory

EpiPen and EpiPen Jr Auto Injector: Pfizer Canada Inc. (distributor of EpiPen for Dey Pharma, L.P.) in collaboration with Health Canada would like to remind patients of the correct method to remove the blue safety cap and of the importance of following the instructions for use of EpiPen (0.3 mg epinephrine auto-injector) and EpiPen Jr (0.15 mg epinephrine auto-injector).  It has recently come to our attention that removal of the blue safety cap the wrong way by pulling it sideways or bending and twisting it off may prevent the device from working properly and potentially result in failure to deliver the drug.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2011/epipen_pc-cp-eng.php

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

Summary Basis of Decision: A Summary Basis of Decision is available for Brilinta.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2011_brilinta_132218-eng.php

Drug and Medical Device Recall Listings: The Drug and Medical Device Recall Listings have been updated.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/index-eng.php

 

~~~~~

 

HEADS UP - December 12, 2011

Notices of Compliance - December 5-9, 2011

• Feraheme (ferumoxytol) was approved as a hematinic on December 8, 2011.

• Mozobil (plerixafor) was approved as a hematopoitic agent on December 8, 2011.

• Resotran (formerly Resolor) (prucalopride succinate) was approved as an enterokinetic agent on December 7, 2011.

• Onbrez Breezhaler (indacaterol maleate) was approved as a long-acting beta2 agonist on December 6, 2011.

News from Health Canada

Health Canada

Advisory: Health Canada is updating Canadians with respect to its review of bisphosphonate drugs, used to treat osteoporosis, and the risk of a rare but serious type of thigh bone fracture known as an "atypical femur fracture."
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_172-eng.php

Therapeutic Products Directorate (TPD)

Guidance Document: A draft guidance on the Use of Foreign Reviews by Health Canada is available. There is an update to Appendix 3.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/draft_foreign_rev_ebauche_exam_etra-eng.php#a15

Consultation: Health Canada has opened a consultation on the Cleaning Validation Guidance (GUI-0028).
http://www.hc-sc.gc.ca/dhp-mps/consultation/compli-conform/2011-gui-0028_ltr-eng.php

www.jptcp.com/files/Cleaning_Validation_GUI_0028_EN.pdf 

(Consultation Document)

Consultation: Health Canada has opened a consultation on the Guidance on Process Validation: Terminal Sterilization Processes for Pharmaceutical Products (GUI-0074).
http://www.hc-sc.gc.ca/dhp-mps/consultation/compli-conform/2011-gui-0074_ltr-eng.php

www.jptcp.com/files/GUI_0074_E.pdf
(Consultation Document)

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

Notice of Compliance with conditions (NOC/c):  A Notice of Compliance with conditions (NOC/c) has been issued for Apo-Letrozole.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/apo_letrozole_129717-eng.php

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/apo_letrozole_fs_fd_129717-eng.php
(Fact Sheet Apo-Letrozole)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/apo_letrozole_dhcpl_lapds_129717-eng.php
(Dear Health Care Professional Letter Apo-Letrozole)

Notice: This notice is to provide guidance to medical device licensees on the process for an opportunity to be heard in respect of a medical device licence suspension according to sections 40 to 42 of the Medical Devices Regulations (The Regulations).
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/md_notice_suspension_im_avis-eng.php

Report:  The 2010-2011 Activities Report is available from the Food and Drugs Act Liaison Office.
http://www.hc-sc.gc.ca/ahc-asc/pubs/_fdalo-bllad/2011/index-eng.php

National Interest

Federal Government – Chemical Substances Challenge

Chemical Substances Challenge: A proposed order to add Quinoline to Schedule 1 to the Environmental Protection Act, 1999 was published.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/quinoline-quinoleine-eng.php

Chemical Substances Challenge: A draft screening assessment report was published for Ethene, 1,1-dichloro- (1,1-dichloroethene) for a 60 day comment period.
http://www.chemicalsubstanceschimiques.gc.ca/plan/approach-approche/1,1-dichloroethene-eng.php

Chemical Substances Challenge: A draft screening assessment report was published for Ethane, 1,2-dibromo- (1,2-dibromoethane) for a 60 day comment period.
http://www.chemicalsubstanceschimiques.gc.ca/plan/approach-approche/1,2-dibromoethane-eng.php

Chemical Substances Challenge: A Status of Prioritized Substances List is now available.
http://www.chemicalsubstanceschimiques.gc.ca/plan/status_prioritized_sub-statut_substances_priorisees-eng.php

Chemical Substances Challenge:  Information sessions concerning the next phase of the Chemicals Management Plan were held between October 13th and 20th 2011. The presentations, offered via Webinar, are now available.
http://www.chemicalsubstanceschimiques.gc.ca/plan/advancing_cmp-avancement_pgpc-eng.php

Gazette I

Canadian Environmental Protection Act, 1999:  A notice has been published following screening assessment of a substance on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999).
http://www.gazette.gc.ca/rp-pr/p1/2011/2011-12-17/html/notice-avis-eng.html#d109

Canadian Environmental Protection Act, 1999:  The results of investigations and recommendations for a substance specified on the Domestic Substances List (paragraphs 68(b) and (c) of the Canadian Environmental Protection Act, 1999) have been published.
http://www.gazette.gc.ca/rp-pr/p1/2011/2011-12-17/html/notice-avis-eng.html#d111  

Food and Drugs Act: Regulations amending the Food and Drug Act have been published in Gazette I.
http://www.gazette.gc.ca/rp-pr/p1/2011/2011-12-17/html/notice-avis-eng.html#d114    

Canadian Environmental Protection Act, 1999:  An order adding a toxic substance to Schedule 1 of the Canadian Environmental Protection Act, 1999 has been published.
http://www.gazette.gc.ca/rp-pr/p1/2011/2011-12-17/html/reg1-eng.html

Gazette II

Canadian Environmental Protection Act, 1999: Order 2011-87-12-01 amending the Domestic Substances List has been published in Gazette II.
http://www.gazette.gc.ca/rp-pr/p2/2011/2011-12-21/html/sor-dors293-eng.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 1, No. 48 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-48

Newsletter: The CADTH Communiqué, Volume 1, No. 49 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-49

Patient Input: Information on one (1) drug (Effient) added to the Call for Patient Input for the Common Drug Review Process is available.
http://www.cadth.ca/en/products/cdr/patient-group-input

Patient Input: Information on one (1) drug (Eliquis) added to the Call for Patient Input for the Common Drug Review Process is available.
http://www.cadth.ca/en/products/cdr/patient-group-input
 

 

~~~~~

 

HEADS UP - November 28, 2011

Notices of Compliance - November 21-25, 2011

• There were no new NOCs published this week.

News from Health Canada

Health Canada

News Release: Dr. Colin Carrie, Parliamentary Secretary on Health, held roundtable discussions today with members of the Traditional Chinese Medicine community to hear their perspectives on the regulation of Traditional Chinese Medicines in Canada.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2011/2011_163-eng.php

Advisory: Health Canada has completed a safety review of drospirenone-containing oral contraceptives (marketed under the brand names Yasmin and Yaz) with respect to the risk of blood clots (venous thromboembolism, or VTE). The review determined that drospirenone-containing birth control pills may be associated with a risk of blood clots that is 1.5 to 3 times higher than other birth control pills.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_164-eng.php

Advisory: Health Canada is advising Canadians that we have updated our list of unauthorized health products to include "Yanshiwang", "Jin Kong Fu" and "Chong Cao She Bian Zhuang Yang Dan".
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_162-eng.php

Biologics, Radiopharmaceuticals & Genetic Therapies Directorate (BGTD)

Record of Meeting: A Record of Meeting is available for the meeting of the Expert Advisory Committee on Blood Regulations held on November 18, 2010.
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/activit/com/eacbr-ccers/_meet-reunion/mm-crr_2010-11-18-eng.php

Record of Meeting: A Record of Meeting is available for the meeting of the Expert Advisory Committee on Cells, Tissues and Organs held November 18, 2010.
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/activit/com/eaccto-ccecto/rom-crr_2010-11-18-eng.php

Natural Health Products Directorate (NHPD)

Insert: An insert has been released on adverse event reporting for Natural Health Products.
http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_fs-if/2011-reporting-declaration_nhp-psn/index-eng.php

Workshop: The Natural Health Products Directorate (NHPD) invites you to attend a workshop on good manufacturing practices (GMPs) for natural health products. The workshop will consist of presentations and “hands-on” learning opportunities for participants to gain familiarity with, and increase their knowledge of GMPs.
 www.jptcp.com/files/NHPD_Workshop_e_mail.pdf

Therapeutic Products Directorate (TPD)

Health Care Professional Advisory

Sublinox (zolpidem tartrate): MEDA VALEANT PHARMA CANADA INC., in consultation with Health Canada, would like to bring to your attention important safety information concerning the association of Sublinox™ with complex sleep behaviours.
http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/sublinox_hpc-cps-eng.php

Ursodiol (ursodeoxycholic acid, UDCA): The manufacturers of ursodiol (Aptalis Pharma Canada Inc., Dominion Pharmacal, Pharmascience Inc., Pharmel Inc., Teva Canada Ltd.), in consultation with Health Canada, would like to inform you of important new information regarding ursodiol (ursodeoxycholic acid, UDCA) [URSO®, URSO DS® , Dom-URSODIOL C, phl-URSODIOL C, pms-URSODIOL C, TEVA-URSODIOL].
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/ursodiol_hpc-cps-eng.php

Avastin (bevacizumab): Hoffmann-La Roche Limited (Roche), in consultation with Health Canada, would like to inform you of important new safety information regarding unauthorized intravitreal use of AVASTIN® (bevacizumab).
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/avastin_8_hpc-cps-eng.php

Consumer Health Advisory

Sublinox (zolpidem tartrate): MEDA VALEANT PHARMA CANADA INC., in consultation with Health Canada, would like to bring to your attention important safety information about Sublinox™ (zolpidem) and abnormal sleep behaviours called complex sleep behaviours.
http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2011/sublinox_pc-cp-eng.php

Ursodiol (ursodeoxycholic acid, UDCA): The manufacturers of ursodiol (Aptalis Pharma Canada Inc., Dominion Pharmacal, Pharmascience Inc., Pharmel Inc., and Teva Canada Ltd.), in consultation with Health Canada, would like to inform you of important new information regarding ursodiol.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2011/ursodiol_pc-cp-eng.php

Avastin (bevacizumab): Hoffmann-La Roche Limited (Roche), in consultation with Health Canada, has informed Canadian healthcare providers of important new safety information regarding the unauthorized use of AVASTIN® (bevacizumab) when injected into the eye.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2011/avastin_8_pc-cp-eng.php

Notice of Compliance with conditions (NOC/c):  A Notice of Compliance with conditions (NOC/c) has been issued for Avastin.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/avastin_nocc_130719-eng.php

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/avastin_fs_fd_130719-eng.php
(Fact Sheet Avastin)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/avastin_dhcpl_lapds_130719-eng.php
(Dear Health Care Professional Letter Avastin)

Notice of Decision: A Notice of Decision has been issued for Efracea.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/nd_ad_2011_efracea_143439-eng.php

Consultation: The final compilation of recommendations of the Scientific Advisory Committee on Oncology Therapies (SAC-OY), Arsenic Trioxide is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-com/onco/sacot_ccsot_rec_arsen_triox-eng.php

Form: An application form is available for custom-made devices and medical devices for special access.
http://www.hc-sc.gc.ca/dhp-mps/acces/md-im/md_sap_im_pas_form-eng.php

Instructions: Instructions are available for completion of the application form for custom-made devices and medical devices for special access.
http://www.hc-sc.gc.ca/dhp-mps/acces/md-im/sapmd_pasmd_inst-eng.php

Study Guide: Study guide GD211 is available for the guidance on the content of quality management system audit reports.
http://www.hc-sc.gc.ca/dhp-mps/md-im/qualsys/md_im_stu_gui_etude_GD211-eng.php

Guidance Document: Health Canada is pleased to announce the release of the final version of the Guidelines for Human Immunodeficiency Virus (HIV) Test Kits-Laboratory Use (September 2001), now known as Guidance for Manufacturers of Human Immunodeficiency Virus (HIV) Test Kits intended to be used in the Laboratory.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/md_gd_hiv_im_ld_vih-eng.php

National Interest

Gazette I

Canadian Environmental Protection Act, 1999:  An order amending the Non-domestic substances List was published.
http://www.gazette.gc.ca/rp-pr/p1/2011/2011-12-03/html/notice-avis-eng.html#d107

Gazette II

Food and Drugs Act: Regulations amending the Food and Drug Regulations (1577 — Schedule F) are available.
http://www.gazette.gc.ca/rp-pr/p2/2011/2011-12-07/html/sor-dors273-eng.html

Food and Drugs Act: Regulations Amending the Food and Drug Regulations (1651 — Schedule F) are available.
http://www.gazette.gc.ca/rp-pr/p2/2011/2011-12-07/html/sor-dors274-eng.html

Food and Drugs Act: Regulations Amending the Food and Drug Regulations (1656 — Schedule F) are available.
http://www.gazette.gc.ca/rp-pr/p2/2011/2011-12-07/html/sor-dors275-eng.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Patient Input: Information on one (1) drug (Saphris) added to the Call for Patient Input for the Common Drug Review Process is available.
http://www.cadth.ca/en/products/cdr/patient-group-input

Newsletter: The CADTH Communiqué, Volume 1, No. 46 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-46

National Association of Pharmacy Regulatory Authorities (NAPRA)

Recommendations: The initial recommendations made by The National Drug Scheduling Advisory Committee (NDSAC) on September 11-12, 2011 were finalized effective November 16, 2011. Final approval of the initial recommendations was made by NAPRA's Executive Committee, in consideration of comments received during the 30-day review period. The National Drug Schedules will be amended accordingly.
www.jptcp.com/files/NDSAC_Final_Recommendations_e_mail.pdf
 

 

~~~~~

 

HEADS UP - November 21, 2011

Notices of Compliance- November 14-18, 2011

• Efracea (doxycycline monohydrate) was approved as an anti-rosacea on November 14, 2011.

News from Health Canada

Health Canada

Advisory: Health Canada is advising Canadians of its decision to suspend authorization of Avastin for use in the treatment of a certain type of breast cancer (metastatic breast cancer).
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_159-eng.php

Advisory: An unauthorized health product, “Stiff One Hard 169” is being voluntarily recalled from the Canadian market after Health Canada’s testing identified an undeclared prescription medication in the product (thiodimethylsildenafil, an undeclared substance similar to the prescription medication sildenafil). “Stiff One Hard 169” is being promoted as a dietary supplement and may pose serious risks to the health of Canadians.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_160-eng.php

Biologics, Radiopharmaceuticals & Genetic Therapies Directorate (BGTD)

Report: The Therapeutics Biologics, Radiopharmaceuticals & Genetic Therapies Directorate (BGTD) Drug Submission Performance Quarterly Report is available for the third quarter (July – September).
www.jptcp.com/files/bgtd_dpbtg_11_q2_eng.pdf

Therapeutic Products Directorate (TPD)

Health Care Professional Advisory

Avastin (bevacizumab): Health Canada has suspended approval of Avastin® (bevacizumab) for use in metastatic breast cancer.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/avastin_7_hpc-cps-eng.php

Information Sheet: A web information sheet has been published on drug shortages.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/announce-annonce/shortage-rupture-eng.php

Report: The Expert Advisory Panel on the use of Avastin in metastatic breast cancer has released its report.
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/activit/sci-consult/avastin/report-rapport-eng.php

Drug and Medical Device Recall Listings: The Drug and Medical Device Recall Listings have been updated.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/index-eng.php

Record of Decisions:  A Record of Decisions is available for the June 27, 2011 meeting between Health Canada and the Canadian Generic Pharmaceutical Association (CGPA).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/assoc/2011-06-27-eng.php

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

Summary Basis of Decision: A Summary Basis of Decision is available for Gilenya.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2011_gilenya_137516-eng.php

Guidance Document: Health Canada has released the guidance document: How to Complete the Application for a New Medical Device Licence.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/md_gd_licapp_im_ld_demhom-eng.php

Form: A new Class IV Medical Device Licence Application Form is available.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/licapp_demhom_cla4-eng.php

Form: A new Class IV Medical Device Licence amendment application form is available.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/md_licam_im_demmhom_cla4-eng.php

Form: A new Class III Medical Device Licence amendment application form is available.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/md_licam_im_demmhom_cla3-eng.php

Form: A new Class II Medical Device Licence amendment application form is available.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/md_licam_im_demmhom_cla2-eng.php

Report: The Therapeutics Product Directorate (TPD) Drug Submission Performance Quarterly Report is available for the third quarter (July – September).
www.jptcp.com/files/tpd_dpt_11_q2_eng.pdf

National Interest

Federal Government – Chemical Substances Challenge

Chemical Substances Challenge: A notice of intent to amend the Domestic Substances List for 1 substance in Batch 6 of the challenge is available.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-6/index-eng.php

Gazette I

Canadian Environmental Protection Act, 1999:  A notice of intent to amend the Domestic Substances List under subsection 87(3) of the Canadian Environmental Protection Act, 1999 to indicate that subsection 81(3) of that Act applies to Benzene, (chloromethyl) is available.
http://www.gazette.gc.ca/rp-pr/p1/2011/2011-11-26/html/notice-avis-eng.html#d109

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 1, No. 45 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-vol-1-no-45
 

 

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HEADS UP - November 14, 2011

Notices of Compliance - November 7-11, 2011

• There were no new NOCs published this week.

News from Health Canada

HPFB Inspectorate

Guidance Document: A guidance document: entitled Alternate Sample Retention Site Guidelines has been released.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/form/gui-0014_doc-eng.php

Therapeutic Products Directorate (TPD)

Membership List: A membership list and biographies has been published for the Scientific Advisory Committee on Nonprescription Drugs.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-com/nonpres/sacnpd_ccsmvl_m_bio-eng.php

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-com/nonpres/sacnpd_ccsmvl_ai-eng.php
(Summary of Expertise, Experience and Affiliations and Interests for the Scientific Advisory Committee on Nonprescription Drugs (SAC-NPD)).

Summary Basis of Decision: A Summary Basis of Decision is available for MENTOR MEMORYGEL™ CPG Breast Implants Cohesive III.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/md-im/sbd_smd_2011_mentorcpg_86150-eng.php

Summary Basis of Decision: A Summary Basis of Decision is available for NATRELLE™ Highly Cohesive Silicone-Filled Breast Implants.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/md-im/sbd_smd_2011_natrellecohesive_88573-eng.php

Summary Basis of Decision: A Summary Basis of Decision is available for
NATRELLE™ Highly Cohesive Silicone-Filled Breast Implants And NATRELLE™ Silicone-Filled Breast Implants - Textured Shell With Barrier Layer.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/md-im/sbd_smd_2011_natrelleround_61865_60524-eng.php

Summary Basis of Decision: A Summary Basis of Decision is available for MENTOR MEMORYGEL™ Silicone Gel-Filled Breast Implants.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/md-im/sbd_smd_2011_mentorround-69312-eng.php

News Release: The response of Health Canada to the Report of the Interim Auditor General Chapter 4: Regulating Pharmaceutical Drug has been released.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2011/2011_157-eng.php

Nomination Call for Members:  Health Canada is seeking nominations for members for the Scientific Advisory Committee on Pharmaceutical Sciences and Clinical Pharmacology (SAC-PSCP).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-com/pharma/sacpscp_ccssppc_inv-eng.php

Draft Terms of Reference: Draft terms of reference are available for the Scientific Advisory Committee on Pharmaceutical Sciences and Clinical Pharmacology (SAC-PSCP).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-com/pharma/sacpscp_tor_ccssppc_att-eng.php

Consultation: Health Canada has opened a consultation on proposed changes to the Therapeutic Products Directorate's (TPD) List of Recognized Standards for medical devices.
http://www.hc-sc.gc.ca/dhp-mps/consultation/md-im/consult_md_draft_rec_stand_im_ebauche_norm_lst-eng.php

Form: A new Class III Medica Device Licence Application Form is available.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/licapp_demhom_cla3-eng.php

Form: A new Class II Medical Device Licence Application Form is available.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/licapp_demhom_cla2-eng.php

National Interest

Federal Government – Chemical Substances Challenge

Chemical Substances Challenge: In November 2011, the Final Screening Assessment Report on Quinoline was released and the related notice was published in the Canada Gazette, Part I, Vol. 145, No. 47 - November 19, 2011.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/quinoline-quinoleine-eng.php

Gazette I

Canadian Environmental Protection Act, 1999:  A final decision has been published after screening assessment of Quinoline.
http://www.gazette.gc.ca/rp-pr/p1/2011/2011-11-19/html/notice-avis-eng.html#d102

Canadian Agency for Drugs and Technologies in Health (CADTH)

Report: CADTH’s work is highlighted in the CIHI report on health care cost drivers.
http://www.cadth.ca/en/media-centre/2011/cadth-work-highlighted-in-cihi-report-on-health-care

Newsletter: The CADTH Communiqué, Volume 1, No. 44 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-vol-1-no-44

Public Health Agency of Canada

Seasonal Flu Guide: A new seasonal flu guide is available.
http://www.phac-aspc.gc.ca/cpho-acsp/statements/20111121-eng.php
 

 

~~~~~

 

HEADS UP - November 7, 2011

Notices of Compliance - October 31 - November 4, 2011

• There were no new NOCs published this week.

News from Health Canada

Therapeutic Products Directorate (TPD)

Health Care Professional Advisory

Avastin (bevacizumab): Hoffmann-La Roche Limited (Roche), in consultation with Health Canada, would like to inform you of an important update to the safety information regarding the use of Avastin. A higher incidence of new cases of ovarian failure has been observed in premenopausal women treated with AVASTIN® (bevacizumab).
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/avastin_6_hpc-cps-eng.php

Consumer Health Advisory

Avastin (bevacizumab): Hoffmann-La Roche Limited (Roche), in consultation with Health Canada, has informed Canadian healthcare providers of important new safety information regarding the use of Avastin.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2011/avastin_6_pc-cp-eng.php

Drug and Medical Device Recall Listings: The Drug and Medical Device Recall Listings have been updated.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/index-eng.php

Notice of Decision: On July 28, 2011, Health Canada issued a Notice of Compliance to Boehringer Ingelheim (Canada) Ltd. for the drug product, Trajenta™.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/nd_ad_2011_trajenta_140881-eng.php

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

Notice of Decision: On October 12, 2011, Health Canada issued a Notice of Compliance to Bayer Inc. for the drug product, Visanne.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/nd_ad_2011_visanne_132174-eng.php

Notice: In accordance with the Processing and Distribution of Semen for Assisted Conception Regulations, processors and importers of donor semen shall give a written notice to Health Canada at least 10 days prior to commencing the processing and/or importation of donor semen and within 90 days of ceasing these activities. The following is a list of Canadian processors and importers that have notified Health Canada of their activities.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/info-prod/don/can_semen_est-eta_can_sperme-eng.php

Health Advisory: CooperVision, in consultation with Health Canada, is expanding the product list of their voluntary worldwide recall of contact lenses. Health Canada is working with the company to identify which products on the Canadian market are affected by the recall.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_156-eng.php

National Interest

Federal Government – Chemical Substances Challenge

Chemical Substances Challenge: In November 2011, the Final Screening Assessment Report on Hexabromocyclododecane (HBCD) was released and the relating notice was published in the Canada Gazette, Part I, Vol. 145, No. 46 - November 12, 2011.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/hexabromo-eng.php

Gazette I

Canadian Environmental Protection Act, 1999:  A final decision has been published after screening assessment of a substance — hexabromocyclododecane (subsection 77(6) and section 68 of the Canadian Environmental Protection Act, 1999).
http://www.gazette.gc.ca/rp-pr/p1/2011/2011-11-12/html/notice-avis-eng.html#d104

Canadian Agency for Drugs and Technologies in Health (CADTH)

Agreement: On October 26, 2011, the Canadian Agency for Drugs and Technologies in Health (CADTH) signed an agreement with the Pan American Health Organization (PAHO), granting PAHO permission to translate the Rx for Change database into Spanish.
http://www.cadth.ca/en/media-centre/2011/cadth-signs-agreement-with-the-pan-american-health

Newsletter: The CADTH Communiqué, Volume 1, No. 43 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-vol-1-no-43

Newsletter: The Common Drug Review Update – Issue 78 is available and discusses changes to the Procedure for Common Drug Review and the Common Drug Review Submission Guidelines for Manufacturers.
http://www.cadth.ca/en/products/cdr/cdr-update/cdr-update-issue-78

Report: A Rapid Response Report has been released on the use of Nabilone for chronic pain management.
http://www.cadth.ca/media/pdf/htis/oct-2011/RC0306-000%20Nabilone%20for%20chronic%20pain.pdf

Report:  A Rapid Response Report has been released on clinical effectiveness and guidelines for compression garments for the treatment of primary and secondary lymphedema.
http://www.cadth.ca/media/pdf/htis/oct-2011/RB0437-000%20Lymphedema.pdf

Patented Medicine Prices Review Board (PMPRB)

Presentation:  Michelle Boudreau, Executive Director, delivered a presentation, Canada’s Patented Medicine Prices Review Board, at the 10th Annual Conference on Market Access, in Toronto.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=1511&id=269

Canadian Institutes for Health Research

Study Results: New research shows steroid medications may slow brain development in preemies.
http://www.cfri.ca/news/media/steroid-medications-may-slow-brain-development-in-preemies.asp
 

 

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HEADS UP- October 31, 2011

Notices of Compliance- October 24-28, 2011

• There were no new NOCs published this week.

News from Health Canada

Health Canada

Health Advisory: Health Canada is advising Canadians that Colgate-Palmolive is recalling their "Colgate Motion Electric Toothbrush". Consumers and retailers should contact the company directly at 1-800-268-6757 or motion@colpal.com for more information.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_146-eng.php

Health Advisory: Patients with a rare condition known as myasthenia gravis who take a fluoroquinolone antibiotic may risk a worsening of their symptoms, including muscle weakness or breathing problems.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_147-eng.php

Foreign Product Alert: Health Canada is advising consumers not to use the following four (4) products due to concerns about possible side-effects: Maxidus capsules, Chao Jimengnan SuperPowerful Man tablets, Fu Yuan Chun capsules and Qing Tian Zhu tablets.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-149-eng.php

Foreign Product Alert: Health Canada is advising consumers not to use the following product due to concerns about possible side-effects: Pancre-Plus (counterfeit).
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-151-eng.php

Foreign Product Alert: Health Canada is advising consumers not to use the following product due to concerns about possible side-effects: Slimming Kapsul.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-152-eng.php

Foreign Product Alert: Health Canada is advising consumers not to use the following three (3) products due to concerns about possible side-effects: Tian Ma Tu Chung Seven Leave Ginseng, Vall-Boon Tongkat Ali and Pao Ni Kang.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-153-eng.php

Foreign Product Alert: Health Canada is advising consumers not to use the following three (3) products due to concerns about possible side-effects: Majun Dua Istimewa, Raja Maajun-Jerat Dan Seret Angin and Horkut Chooi Foong Hor Lok Tan.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-148-eng.php

Foreign Product Alert: Health Canada is advising consumers not to use the following product due to concerns about possible side-effects: Metabolic Advantage.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-150-eng.php

Foreign Product Alert: Health Canada is advising consumers not to use the following product due to concerns about possible side-effects: Zhui Feng Bao Wei San.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-154-eng.php

Biologics, Radiopharmaceuticals & Genetic Therapies Directorate (BGTD)

Record of Meeting: A record of meeting is available for the bilateral meeting of the Nuclear Medicine Alliance and the Biologic and Genetics Therapies Directorate (BGTD).
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/activit/meet-reunion/nma-mm-crr-2011-06-20-eng.php

Therapeutic Products Directorate (TPD)

Health Care Professional Advisory

Pradax/Plavix: Boehringer Ingelheim (Canada) Ltd., and sanofi-aventis Canada Inc. (on behalf of Bristol-Myers Squibb Sanofi Canada partnership) in consultation with Health Canada, would like to alert you to the risk of medication errors associated with name confusion between the anticoagulant Pradax® (dabigatran etexilate) from Boehringer Ingelheim (Canada) Ltd. and the antiplatelet drug Plavix® (clopidogrel bisulfate) from sanofi-aventis Canada Inc.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/plavix_2_hpc-cps-eng.php

Consumer Health Advisory

Pradax/Plavix: Boehringer Ingelheim (Canada) Ltd., and sanofi-aventis Canada Inc. (on behalf of Bristol-Myers Squibb Sanofi Canada partnership) in consultation with Health Canada, would like to alert patients to the risk of medication errors associated with the mix-up of the names of two prescription drugs, Pradax® (dabigatran) and Plavix®(clopidogrel).
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2011/plavix_2_pc-cp-eng.php

Statement: On Oct. 6-7, 2011, representatives from the medical device regulatory authorities of Australia, Brazil, Canada, China, European Union, Japan and United States, as well as the World Health Organisation (WHO), met in Ottawa to address the establishment and operation of a new organization, the International Medical Device Regulators' Forum (IMDRF).
http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/int/statement_imdrf_declar_fiacrmm-eng.php

Draft Guidance Document: A draft guidance document for Clinical Field Sponsors – Clinical Trial Applications has been released for a 90-day comment period. Health Canada will review the comments received during this comment period and revise the Guidance as necessary. A final version of this document will then be posted.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult_draft_ctdcta_ebauche_ctddec-eng.php

www.jptcp.com/files/draft_ctdcta_ebauche_ctddec_eng.pdf

(Guidance document)

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 1, No. 42 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-vol-1-no-42

Canadian Institute for Health Information

Report: The report: National Health Expenditure Trends, 1975 to 2011 is available.
https://secure.cihi.ca/estore/productFamily.htm?locale=en&pf=PFC1671

Report: The report: Health Care Cost Drivers: The Facts is available.
https://secure.cihi.ca/estore/productFamily.htm?locale=en&pf=PFC1672
 

 

~~~~~

 

HEADS UP - October 24, 2011

Notices of Compliance - October 17-21, 2011

• There were no new NOCs published this week.

News from Health Canada

Therapeutic Products Directorate (TPD)

Health Care Professional Advisory

Xigris: Eli Lilly and Company is undertaking a worldwide withdrawal of Xigris® [drotrecogin alfa (activated)] due to new clinical trial findings of lack of efficacy which calls into question the benefit-risk profile of the product.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/xigris_4_hpc-cps-eng.php

Notice to Hospitals

Xigris: Health Canada has endorsed important new benefit-risk information on Xigris [drotrecogin alfa (activated)].
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/xigris_4_nth-aah-eng.php
 
Consumer Health Advisory

Xigris: Eli Lilly and Company is undertaking a worldwide withdrawal of Xigris® [drotrecogin alfa (activated)].
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2011/xigris_4_pc-cp-eng.php

Notice:  Health Canada would like to inform sponsors that drug submissions for brand name changes to their product which require a brand name assessment and/or Look-alike Sound-alike (LA/SA) assessment will no longer be acceptable for processing as an administrative drug submission pursuant to the Policy Changes in Manufacturer's Name and/or Product Name.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/announce-annonce/notice_brandname_clarif_avis_marqnom-eng.php

Drug and Medical Device Recall Listings: The Drug and Medical Device Recall Listings have been updated.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/index-eng.php

Record of Decisions: A Record of Decisions is available for the June 8, 2011 meeting between Health Canada and Groupement provincial de l'industrie du médicament (GPIM).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/assoc/2011-06-08-eng.php

Notice of Decision: On September 22, 2011, Health Canada issued a Notice of Compliance to Genzyme Canada Inc. for a drug product that contains the medicinal ingredient colesevelam hydrochloride, a bile acid sequestrant. The brand name is yet to be determined.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/nd_ad_2011_colesevelam_hydrochloride_133463-eng.php

Record of Decisions:  An agenda for the bilateral meeting program with the Compressed Gas Association held on October 29, 2011 is available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/activit/meet-reunion/cga-agm-20091029-eng.php

Guidance Document: Health Canada is pleased to announce the release of the Guidance Document: Preparation of STED-based Class III and Class IV Premarket Medical Device Licence Applications, not including In Vitro Diagnostic Devices (IVDDs).
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/md_gd_im_ld_sted-eng.php

National Interest

Gazette I

Order: The Patented Medicines Prices Review Board has issued an order in Gazette I.
http://www.gazette.gc.ca/rp-pr/p1/2011/2011-10-29/html/commis-eng.html#f110

Canadian Agency for Drugs and Technologies in Health (CADTH)

Announcement: CADTH launches its updated virtual library of diabetes reports, tools, and other resources — conveniently collecting them in one place.
http://www.cadth.ca/en/media-centre/2011/cadths-diabetes-virtual-library

Newsletter: The CADTH Communiqué, Volume 1, No. 41 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-vol-1-no-41

Announcement: The Canadian Agency for Drugs and Technologies in Health (CADTH) today announced the appointment of a Public Member to its recently established Health Technology Expert Review Panel. The Panel is an advisory body, convened to develop guidance and recommendations to CADTH on non-drug health technologies such as medical devices.
http://www.cadth.ca/en/media-centre/2011/4-canadian-agency-for-drugs-and-technologies-in-health

Pharmaceutical Advertising Advisory Board (PAAB)

Newsletter: The October 2011 issue of the PAAB Review is available.
http://www.paab.ca/local/files/PAAB%20Review%20Newsletter%20October%20%202011%20E.pdf

Patented Medicine Prices Review Board (PMPRB)

Analysis Briefs: The PMPRB launches the first issue in its new Analysis Briefs series.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=1568

Newsletter: The October 2011 issue of the PMPRB NEWSletter is available.
http://www.pmprb-cepmb.gc.ca/CMFiles/Publications/Newsletter/News-Oct2011-e-online.pdf
 

 

~~~~~

 

HEADS UP - October 17, 2011

Notices of Compliance - October 10-14, 2011

• Visanne (dienogest) was approved as a progestin on 2011-10-12.

News from Health Canada

Health Canada

Information Update: Health Canada is informing Canadians that it is working with Eli Lilly Canada, Inc. to withdraw the drug Xigris (drotrecogin alfa) from the Canadian market, in light of the company's decision to withdraw Xigris from the market worldwide.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_142-eng.php

Natural Health Products Directorate (NHPD)

Instructional Videos: The Natural Health Products Online Solution has issued five (5) new instructional videos on how to use the various electronic tools and forms.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/online-enligne/video-instruct-eng.php

Advisory: Health Canada is advising Canadians of the voluntary recall by Puresource Inc. of three lots of NOW Brewer's Yeast (10 grain) Tablets due to the presence of an undeclared milk allergen. The products affected by this recall are bottles of 200 tablets (Lot numbers: 1401411, 1365681 and 1343111).
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_143-eng.php

Meeting:  The agenda from the Natural Health Products Program Advisory Committee Meeting #10 held September 19-20, 2011 is available.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/activit/com/program-19-09-2011-eng.php

Therapeutic Products Directorate (TPD)

Health Care Professional Advisory

Strattera (atomoxetine): Eli Lilly Canada Inc. in collaboration with Health Canada would like to inform you of important information from clinical studies regarding the risk of increased blood pressure and increased heart rate with the use of Strattera (atomoxetine).
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/strattera_2_hpc-cps-eng.php

SynchroMed II Implantable Drug Infusion Pumps: An urgent medical device correction letter has been issued. On July 13, 2009, Medtronic sent a Medical Device Correction letter to Healthcare Professionals regarding the potential for reduced battery performance that could lead to sudden loss of therapy in a small percentage of Medtronic Model 8637 SynchroMed® II pumps. The purpose of this communication is to provide you with updated information.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/synchromed_infusion_hpc-cps-eng.php

Consumer Health Advisory

Strattera (atomoxetine): Eli Lilly Canada Inc. together with Health Canada would like to inform patients and their caregivers of important information about the risk of increased blood pressure and increased heart rate with the use of Strattera (atomoxetine).
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2011/strattera_2_pc-cp-eng.php

Summary Basis of Decision: A Summary Basis of Decision is available for Banzel.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2011_banzel_139913-eng.php

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

Overview: An overview of nano-technology-based health products and food is available.
http://www.hc-sc.gc.ca/dhp-mps/nano-eng.php

Notice: A summary has been published of all changes to the Guidance Document for Mandatory Problem Reporting for Medical Devices and the Mandatory Medical Device Problem Reporting Form for Industry.
http://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hpfb-dgpsa/mhpd-dpsc/devices-materiaux_reporting-notification-2011-eng.php

National Interest

Federal Government – Chemical Substances Challenge
Chemical Substances Challenge: The Siloxane D5 Board of Review has published a report.
http://www.ec.gc.ca/lcpe-cepa/6E52AE02-5E01-48B0-86DE-0C366ACC863F/CdR-BoR-D5_eng.pdf

Canadian Intellectual Property Office (CIPO)
Announcement: To facilitate future improvements in electronic commerce and to increase client self-sufficiency, CIPO will soon implement updates to the online application forms for registration of copyright.
http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr03067.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 1, No. 40 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-vol-1-no-40

Patented Medicine Prices Review Board (PMPRB)

Voluntary Compliance Undertaking: The Chairperson of the Board accepted a voluntary compliance undertaking (VCU) for Orgalutran.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=265

Order: The Hearing Panel issued a board order in the matter of Ratiopharm Inc. and the medicine ratio-Salbutamol HFA, concluding the proceedings.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=266

Public Health Agency of Canada

Report:  Report on the State of Public Health in Canada 2011 is now available.
http://www.phac-aspc.gc.ca/cphorsphc-respcacsp/2011/index-eng.php

Canadian Institutes of Health Research

Study Results: The international Structural Genomics Consortium (SGC) has announced that $48.9 million in new funding has been attained. This renewed investment will allow the SGC to further develop its open access research program to support drug discovery and the development of new medicines.
http://www.cihr-irsc.gc.ca/e/20452.html
 

 

~~~~~

 

HEADS UP - October 10, 2011

Notices of Compliance - October 3 - 7, 2011

• Saphris (asenapine) was approved as an antipsychotic agent on 2011-10-07.

On the Move

• The Canadian Agency of Drugs and Technologies in Health (CADTH) wishes to announce changes to its Executive Team. http://www.cadth.ca/en/media-centre/2011/cadth-executive-team-changes

News from Health Canada

Health Canada

Information Update: Health Canada is reviewing the heart-related safety of the prescription antidepressant citalopram. The review is in light of new study data suggesting that high doses (60 mg/day) can affect the electrical activity of the heart. The changes in electrical activity could potentially lead to serious, possibly fatal abnormal heart rhythms.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_134-eng.php

Foreign Product Alert: Health Canada is advising consumers not to use the following four (4) weight loss products due to concerns about possible side-effects: Slim Forte Slimming Capsules, Slim Forte Double Power Slimming Capsules, Slim Forte Slimming Coffee and Meizitang Botanical Slimming Soft Gel.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-141-eng.php

Foreign Product Alert: Health Canada is advising consumers not to use [W.S] Gan Mao Ling or Chaisentomg Baby's Kam Chik San Powder due to concerns about possible side-effects.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-137-eng.php

Foreign Product Alert: Health Canada is advising consumers not to use OxyELITE Pro capsules (often promoted as Oxy Elite Pro capsules) or Pure Fat Three Days Reduce Weight capsules due to concerns about possible side-effects.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-139-eng.php

Foreign Product Alert: Health Canada is advising consumers not to use Huo Li Bao or Ren Sem Tu Chon Chin Kuo Pill due to concerns about possible side-effects.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-138-eng.php

Foreign Product Alert: Health Canada is advising consumers not to use SXL Sexcellence sachets due to concerns about possible side-effects.
http://hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-140-eng.php

Meeting: The Honourable Leona Aglukkaq, Minister of Health, held roundtable discussions today with members of the Traditional Chinese Medicine (TCM) community to hear their perspectives on the regulation of Traditional Chinese Medicines in Canada.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2011/2011_135-eng.php

Therapeutic Products Directorate (TPD)

Consultation: Health Canada has opened a consultation on a proposed amendment to the Food and Drug Regulations - Project # 1470 - Non-Medicinal Ingredient (NMI) Formulation.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult_project_projet_1470-eng.php

http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/project_projet-1470_v2-eng.php
(Consultation Document)

Consultation: The Health Products and Food Branch (HPFB) of Health Canada is seeking input on proposals for Phase II of the Summary Basis of Decision (SBD) project.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult_sbd_smd_e_consult-eng.php

Listings: The Drug and Medical Device Recall Listings have been updated.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/index-eng.php

Notice: A notice has been published related to the Guidance for Industry: Preparation of a Premarket Review Document in Electronic Format for a Class III and Class IV Medical Device Licence Application. It is intended to assist manufacturers and regulatory correspondents in preparing a premarket review document in an electronic format for a Class III and Class IV medical device licence application.
http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/announce-annonce/notice_e-form_class_iii_iv_avis-eng.php

National Interest

Federal Government – Chemical Substances Challenge

Chemical Substances Challenge: A proposed order to add 3 substances in Batch 11 of the Challenge to Schedule 1 of the Canadian Environmental Protection Act, 1999 is available.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-11/index-eng.php#order

Chemical Substances Challenge:  A proposed order to add 1 substance in Batch 6 of the Challenge to Schedule 1 of the Canadian Environmental Protection Act 1999, is available.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-6/index-eng.php#order

Gazette I

Canadian Environmental Protection Act, 1999: An Order adding toxic substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 is available.
http://www.gazette.gc.ca/rp-pr/p1/2011/2011-10-15/html/reg2-eng.html

Gazette II

Canadian Environmental Protection Act, 1999: Order 2011-87-08-01 amending the Domestic Substances List has been published in Gazette II.
http://www.gazette.gc.ca/rp-pr/p2/2011/2011-10-12/html/sor-dors199-eng.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Seminar/Webinar:  A seminar entitled “Can We Reliably Benchmark HTA Organizations?” was given by Dr. Michael Drummond.
http://www.cadth.ca/en/media-centre/2011/can-we-reliably-benchmark-hta-organizations-seminarwebinar

Newsletter: The CADTH Communiqué, Volume 1, No. 39 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-vol-1-no-39

Patient Input:  Information on five (5) drugs (Gelnique, Rapaflo, Asmanex, Xaretto, Visanne) added to the Call for Patient Input for the Common Drug Review Process is available.
http://www.cadth.ca/en/products/cdr/patient-group-input

 

 

~~~~~

 

HEADS UP - September 26, 2011

Notices of Compliance - September 19 - 23, 2011

• Colesevelam Hydrochloride (Colesevelam HCL) was approved as a bile acid sequestrant on 2011-09-22.

• Ruby-Fill (Rubidium Chloride Rb 82) was approved as a diagnostic radiopharmaceutical on 2011-09-20.

News from Health Canada

Health Canada

Announcement: The Government of Canada announced the renewal of its commitment to protect Canadian families and consumers by updating Canada's world-leading Chemicals Management Plan.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2011/2011-128-eng.php

Biologics, Radiopharmaceuticals & Genetic Therapies Directorate (BGTD)

Meeting: Meeting notes are available for the June 14, 2011 meeting between Health Canada and the BIOTECanada Vaccine Industry Committee (VIC).
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/activit/meet-reunion/vic-civ-mm-crr-2011-06-14-eng.php

Natural Health Products Directorate (NHPD)

Update: An update on the Notice to NHP Stakeholders Regarding Natural Health Products Containing Probiotic and Enzymes is available. The NHPD has received correspondence from affected stakeholders and would like to address some of the questions raised.
 

Therapeutic Products Directorate (TPD)

Update: The quarterly update to the Canada Vigilance Adverse Reaction Online Database has taken place.
http://www.hc-sc.gc.ca/dhp-mps/medeff/databasdon/index-eng.php

Form: A Mandatory Medical Device Problem Reporting Form for Industry is available.
http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/md-mm_form-eng.php

Guidance: A Guidance Document for Mandatory Problem Reporting for Medical Devices is available.
http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_guide/2011-devices-materiaux/index-eng.php

Notice of Compliance with conditions: A Notice of Compliance with conditions (NOC/c) is available for Docetaxel for Injection.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/docetaxel_116151-eng.php

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/docetaxel_fs_fd_116151-eng.php
(Fact Sheet)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/docetaxel_dhcpl_lapds_116151-eng.php
(Dear Health Care Professional Letter)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/docetaxel_qn_aa_116151-eng.php
(Qualifying Notice)

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

Listings: The Drug and Medical Device Recall Listings have been updated.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/index-eng.php

Notice: A Notice is available regarding the increased scope of submissions being accepted in Electronic Common Technical Document (eCTD) electronic-only filing format.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ctd/ectd/notice_scope_ectd_avis_augm-eng.php

Newsletter: The October 2011 edition of the Canadian Adverse Reaction Newsletter, Volume 21 - Issue 4 is available.
http://www.hc-sc.gc.ca/dhp-mps/medeff/bulletin/carn-bcei_v21n4-eng.php

National Interest

Federal Government – Chemicals Management Plan

Chemicals Management Plan: Information sessions concerning the next phase of the Chemicals Management Plan are being offered via webinars. For information on the dates of these sessions and to find out how to register, please contact p.liaison@ec.gc.ca.
http://www1.webcastcanada.ca/cmp/

Chemical Management Plan: The Government of Canada has launched the next phase of the Chemical Management Plan.
http://www.chemicalsubstanceschimiques.gc.ca/plan/index-eng.php

Canadian Environmental Protection Act, 1999: A proposed Order to add mercury and its compounds to Schedule 1 to the Canadian Environmental Protection Act, 1999 was published.
http://www.chemicalsubstanceschimiques.gc.ca/plan/approach-approche/mercury-mercure-eng.php

Federal Government – Copyright Act

Copyright Modernization Act: The Honourable Christian Paradis, Minister of Industry, and the Honourable James Moore, Minister of Canadian Heritage and Official Languages, announced the reintroduction of the Government of Canada's Copyright Modernization Act.
http://www.ic.gc.ca/eic/site/crp-prda.nsf/eng/h_rp01238.html

http://www.parl.gc.ca/HousePublications/Publication.aspx?Language=E&Mode=1&DocId=5144516
(Bill C-11, Copyright Modernization Act)

Gazette I

Canadian Environmental Protection Act, 1999: An Order has been issued adding toxic substances to Schedule 1 to the Canadian Environmental Protection Act, 1999.
http://www.gazette.gc.ca/rp-pr/p1/2011/2011-10-01/html/reg1-eng.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 1, No. 37 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-vol-1-no-37

Consultation: CADTH is pleased to invite all interested parties to provide feedback on the draft science report and draft recommendations report for the CADTH project Atypical Antipsychotics for Schizophrenia: Combination Therapy and High Doses.
http://www.cadth.ca/en/products/optimal-use/atypical-antipsychotics-for-schizophrenia/aap-call-for-feedback

Newsletter: The CADTH Communiqué, Volume 1, No. 38 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-vol-1-no-38

Patented Medicine Prices Review Board (PMPRB)

Reports: The National Prescription Drug Utilization Information System (NPDUIS) has published the following reports.

http://www.pmprb-cepmb.gc.ca/CMFiles/Publications/Analytical%20Studies/NPDUIS-GenericEntryImpact-e-sept30.pdf
(The Impact of Generic Entry on the Utilization of the Ingredient, September 2011)

http://www.pmprb-cepmb.gc.ca/CMFiles/Publications/Analytical%20Studies/NPDUIS-DispensingFees-e-sept30.pdf
(Public Drug Plan Dispensing Fees: A Cost-Driver Analysis, 2001/02 to 2007/08, September 2011)

http://www.pmprb-cepmb.gc.ca/CMFiles/Publications/Analytical%20Studies/NPDUIS-GenericDrugs-IPCs-e-sept30.pdf
(Generic Drugs in Canada: International Price Comparisons and Potential Cost Savings, September 2011)

Environment Canada

Speech: The Honourable Leona Aglukkaq, Minister of Health, and the Honourable Peter Kent, Minister of Environment, announce the renewal of Canada's world-leading Chemicals Management Plan.
http://www.ec.gc.ca/default.asp?lang=En&n=6F2DE1CA-1&news=6C37C78E-F5DC-4DD2-898D-90B5ADEB3832

Public Health Agency of Canada

Statement: A Statement on Seasonal Influenza Vaccine for 2011–2012 is available.
http://www.phac-aspc.gc.ca/publicat/ccdr-rmtc/11vol37/acs-dcc-5/index-eng.php
 

 

~~~~~

 

HEADS UP - September 19, 2011

Notices of Compliance - September 12 - 16, 2011

• There were no new NOCs published during this week.

News from Health Canada

Health Canada

Health Advisory: Health Canada is informing health professionals and patients of updated recommendations involving the use of Plavix in combination with a class of drugs known as proton pump inhibitors (PPIs).
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_125-eng.php

Biologics, Radiopharmaceuticals & Genetic Therapies Directorate (BGTD)

Record of Meeting: A Record of Meeting is available for the June 10, 2010 meeting of the Expert Advisory Committee - Cells, Tissues and Organs.
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/activit/com/eaccto-ccecto/rom-crr_2010-06-10-eng.php

Therapeutic Products Directorate (TPD)

Records of Decision: A Records of Decision is available for the June 20, 2011meeting between Health Canada and the National Association of Pharmacy Regulatory Authorities (NAPRA).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/assoc/2011-06-20-eng.php

Summary Basis of Decision: A Summary Basis of Decision (SBD) is available for Vimpat.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2011_vimpat_116632-eng.php

Drug and Medical Device Recall Listings: The Drug and Medical Device Recall Listings have been updated.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/index-eng.php

Consultation: Health Canada has opened a consultation on the Draft Guidance on Good Manufacturing Practices (GMP) for Medical Gases (GUI-0031).
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/docs/gui-0031-consult-eng.php
(draft Guidance) www.jptcp.com/files/Draft_GUI_0031_GMP_for_Medical_Gases.pdf

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

Summary Basis of Decision: A Summary Basis of Decision (SBD) is available for Jevtana.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2011_jevtana_137421-eng.php

Notice of Decision: A Notice for Decision is available for Incivek.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/nd_ad_2011_incivek_142482-eng.php

National Interest

Advertising Standards Canada (ASC)

Newsletter: The ASC Fall 2011 newsletter, enews, is available.
http://adstandards.com/en/ASCLibrary/newsletters/fall2011/newsletter_ASCNews.aspx

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 1, No. 36 is available.

 http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-vol-1-no-36

Newsletter: The Common Drug Review Update — Issue 77 is available and discusses changes to the Procedure for Common Drug Review and the Common Drug Review Submission Guidelines for Manufacturers.
http://www.cadth.ca/en/products/cdr/cdr-update/cdr-update-issue-77

http://www.cadth.ca/media/cdr/process/CDR_Procedure_e.pdf
(Procedure for Common Drug Review)

http://www.cadth.ca/media/cdr/process/CDR_Submission_Guidelines_e.pdf
(Common Drug Review Submission Guidelines for Manufacturers)

Patented Medicine Prices Review Board (PMPRB)

Speech: Mary Catherine Lindberg gave a speech at the Canadian Association for Healthcare Reimbursement: Healthcare and Biopharmaceuticals in Canada – A Federal Perspective conference on September 21, 2011 in Ottawa.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=223

National Association of Pharmacy Regulatory Authorities (NAPRA)

Meeting: A meeting of the National Drug Scheduling Advisory Committee (NDSAC) was held on September 11-12, 2011. The main purpose of the meeting was to conduct a drug scheduling review (initiated at the request of NAPRA) for the nonprescription nonsteroidal anti-inflammatory drugs (NSAIDs), excluding ASA and acetaminophen, currently available on the Canadian market.
http://napra.ca/pages/home/default.aspx?id=2979
 

 

~~~~~

 

HEADS UP - September 12, 2011

Notices of Compliance - September 5 - 9, 2011

• There were no new NOCs published during this week.

On the Move

• Dr. Brian O’Rourke, President and Chief Executive Officer, Canadian Agency for Drugs and Technologies in Health (CADTH), is pleased to announce the appointment of Matthew Brougham, Vice-President, Products and Services.
http://www.cadth.ca/en/media-centre/2011/matthew-brougham-appointed-cadth-vice-president-products

• The Canadian Agency for Drugs and Technologies in Health (CADTH) announced the appointment of Core Members to its newly established Health Technology Expert Review Panel.
http://www.cadth.ca/en/media-centre/2011/3-canadian-agency-for-drugs-and-technologies-in-health

News from Health Canada

Health Canada

Trasylol: On September 21, 2011, Health Canada informed Canadians of the conclusion of its safety review of the heart-surgery drug Trasylol® (aprotinin).
http://www.hc-sc.gc.ca/dhp-mps/medeff/res/eap-gce_trasylol-eng.php

Biologics, Radiopharmaceuticals & Genetic Therapies Directorate (BGTD)

Proposals: Proposals are available to amend the Food and Drug Regulations with respect to radiopharmaceuticals.
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/legislation/notices-avis/radiopharm_reg-eng.php

Draft Guidance Document: The Draft Guidance Document entitled, “Regulatory Framework for Allergenic Substances of Biological Origin used for the Diagnosis or Treatment of Allergic Diseases”, is available.
http://www.hc-sc.gc.ca/dhp-mps/consultation/biolog/draft_allergenic_ebauche_allergenes-eng.php

http://www.hc-sc.gc.ca/dhp-mps/consultation/biolog/draft_ebauche_allergenic_allergenes-eng.php
(Consultation Document)

http://www.hc-sc.gc.ca/dhp-mps/consultation/biolog/comments_commentaires-eng.php
(Form for Comments)

Natural Health Products Directorate (NHPD)

Product Monographs: The NHPD has recently revised the monograph for Arnica. The Abbreviated Labelling Standards for Marigold Extract and Lutein have been replaced by a product monograph: Marigold Extract and Isolates (Lutein and Zeaxanthin).
www.jptcp.com/files/Marigold_and_isolates_lutein_and_zeaxanthin_2011_08_18.pdf

Therapeutic Products Directorate (TPD)

Notice to Hospitals

Trasylol: Bayer is pleased to announce that the temporary market authorization suspension of Trasylol® (aprotinin) is lifted effective immediately.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/trasylol_3_nth-aah-eng.php

Consumer Health Advisory

Trasylol: Health Canada has endorsed important safety information on Trasylol.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2011/trasylol_3_pc-cp-eng.php

Seminar: The Canadian Cosmetic, Toiletry and Fragrance Association (CCTFA) is presenting the webinar; Border Crossing: The Importing and Exporting of Personal Care Products in Canada on November 30, 2011.
http://www.cctfa.ca/site/events/Border_Crossing_Webinar_2011/Border_Crossing_Reg_Form.pdf

Final Guidance Document: The Final Guidance Document entitled, “Data Requirements for Safety and Effectiveness of Subsequent Market Entry Steroid Nasal Products for Use in the Treatment of Allergic Rhinitis”, has been released.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/inhal-aerosol/nas_rhin-eng.php

Notice of Decision: A Notice of Decision has been issued for Victrelis.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/nd_ad_2011_victrelis_141556-eng.php

Draft Guidance Document: The Draft Guidance Document entitled, “Data Requirements for Safety and Effectiveness of Subsequent Market Entry Inhaled Corticosteroid Products for Use in the Treatment of Asthma”, is available.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult_draft_inhal_ebauche_corticost-eng.php

http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/draft_inhal_ebauche_corticost-eng.php
(Consultation Document)

Framework Document: The Post-Notice of Compliance (NOC) Changes: Framework Document is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/postnoc_change_apresac/noc_pn_framework_ac_sa_cadre-eng.php

Revised Guidance Document: Health Canada is pleased to announce the release of the Revised Guidance Document: Post-Notice of Compliance (NOC) Changes - Quality Guidance Appendix 1 for Human Pharmaceuticals effective October 17, 2011.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/postnoc_change_apresac/noc_pn_quality_ac_sa_qualite-eng.php

National Interest

Advertising Standards Canada (ASC)

Seminar: The ASC will be presenting the seminar; Everyone has Something to Say about Advertising: ASC 2011 Consumer Research Findings on November 16 & 17, 2011.

http://www.adstandards.com/en/Events/201111ResearchFindingsToronto.asp
(Toronto)

http://www.adstandards.com/en/Events/201111ResearchFindingsMontreal.asp
(Montreal)

Seminar: The ASC will be presenting the seminar, Canadian Code of Advertising Standards & Consumer Complaints Procedure on September 28, 2011.
http://www.adstandards.com/en/Events/201109CodeToronto.asp

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 1, No. 35 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-vol-1-no-35

Newsletter: The Common Drug Review Update — Issue 76 is available.
http://www.cadth.ca/en/products/cdr/cdr-update/cdr-update-issue-76

Update: The Rx for Change Database has been updated.
http://www.cadth.ca/en/media-centre/2011/rx-for-change-has-been-updated

Public Health Agency of Canada

Report: An Addendum to the 2010-2011 Seasonal Trivalent Inactivated Influenza Vaccine is available.
http://www.phac-aspc.gc.ca/publicat/ccdr-rmtc/11vol37/acs-dcc-4/index-eng.php
 

 

~~~~~

 

HEADS UP - September 12, 2011

Notices of Compliance - August 29 – September 2, 2011

• There were no new NOCs published during this week.

News from Health Canada

Health Canada

Health Advisory: Following information that a Toronto Company, ACCU-METRICS, has been advertising HIV home test kits for sale via their website, Health Canada would like to remind Canadians that there are currently no HIV test kits that have been authorized for home use in Canada.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_123-eng.php

Health Advisory: Health Canada is informing health professionals and patients about a possible increased risk of certain heart-related events in men being treated for prostate cancer with a type of prescription drug known as a Gonadotropin-Releasing Hormone (GnRH) agonist.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_122-eng.php

Natural Health Products Directorate (NHPD)

Notice: The NHPD has issued a notice to NHP stakeholders regarding Enzyme-Containing Natural Health Products.
www.jptcp.com/files/NHPD.Enzymes.9.14.2011.pdf

Probiotics: The NHPD has issued a message to NHP Stakeholders regarding products containing Probiotics.
 www.jptcp.com/files/NHPD_Probiotics_email.9.14.2011.pdf

Survey: The Natural Health Products Directorate has issued an invitation to complete a survey for an evaluation of Health Canada’s BSE I and BSE II Initiatives.
 www.jptcp.com/files/NHPD_Survey.9.8.2011.pdf

Therapeutic Products Directorate (TPD)

Notice of Decision: A Notice for Decision has been issued for Samsca.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/nd_ad_2011_samsca_139413-eng.php

Record of Decisions: A Record of Decisions is available for the June 22, 2011 meeting between Health Canada and Canada's Medical Device Technology Companies (MEDEC).
http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/meet-reunion/2011-06-22-eng.php

Notice of Compliance with conditions (NOC/c): A Notice of Compliance with conditions (NOC/c) has been issued for Sandoz Letrozole.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/sandoz_letrozole_134725-eng.php

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/sandoz_letrozole_fs_fd_134725-eng.php
(Fact Sheet Sandoz Letrozole)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/sandoz_letrozole_dhcpl_lapds_134725-eng.php
(Dear Health Care Professional Letter Sandoz Letrozole)

Notice: As of October 1, 2011, Health Canada will no longer be providing the Validation Reports or email notifications for submissions that have passed validation. Any submissions that have warnings or fails validation will still have a validation report sent to the sponsor.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ctd/ectd/notice_ectd_validation_avis-eng.php

Consultation: The Draft Guidance Document, ‘The Use of Foreign Reviews by Health Canada’, is available for consultation.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult_draft_foreign_rev_ebauche_exam_etra-eng.php

http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/draft_foreign_rev_ebauche_exam_etra-eng.php
(Consultation Document)

National Interest

Federal Government – Chemical Substances Challenge

Chemical Substances Challenge: An Order amending the Domestic Substances List to apply the Significant New Activity provisions of the Canadian Environmental Protection Act, 1999 to six substances in Batch 11 of the Challenge was published.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-11/index-eng.php

Chemical Substances Challenge: An Order amending the Domestic Substances List to indicate that two substances in Batch 11 of the Challenge meet the Reduced Regulatory Requirement polymer criteria under the New Substances Notification Regulations was published.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-11/index-eng.php

Chemical Substances Challenge: The final screening assessment report for one substance (CHPD) in Batch 1 of the Challenge was published.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-1/index-eng.php

Chemical Substances Challenge: The final screening assessments reports for four substances in Batch 6 of the Challenge were published and the proposed risk management approach document was also released for a 60-day public comment period.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-6/index-eng.php

Chemical Substances Challenge: A final screening assessment report for one substance in Batch 8 of the Challenge was published.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-8/index-eng.php

Chemical Substances Challenge: The final screening assessments reports for substances in Batch 11 of the Challenge were published and the proposed risk management approach documents were also released for a 60-day public comment period.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-11/index-eng.php

Gazette I

Canadian Environmental Protection Act, 1999: The publication of the final decision after screening assessment of substances in Batches 6, 8 and 11 of the Chemical Substances Challenge and the publication of results of investigations and recommendations for a substance are available.
http://www.gazette.gc.ca/rp-pr/p1/2011/2011-09-10/html/index-eng.html

Canadian Environmental Protection Act, 1999: The publication of the final decision after screening assessment of a substance, Propanedinitrile, [[4-[[2-(4-cyclohexylphenoxy)ethyl]ethylamino]2-methylphenyl]methylene]- (CHPD), CAS No. 54079-53-7 — specified on the Domestic Substances List (subsection 77(6) of the Canadian Environmental Protection Act, 1999) is available.
http://www.gazette.gc.ca/rp-pr/p1/2011/2011-09-10/html/index-eng.html

Advertising Standards Canada (ASC)

Seminar: ASC's Trends & Topics Seminar Series: Brand Management in a Crisis - Online & Offline will be held on October 24, 2011.
http://www.adstandards.com/en/Events/201110BrandManagementToronto.asp

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 1, No. 34 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-vol-1-no-34

Consultation: CADTH is pleased to invite all interested parties to provide feedback on draft science reports and on a recommendations report for the CADTH project Optimal Warfarin Management for the Prevention of Thromboembolic Events in Patients with Atrial Fibrillation.
http://www.cadth.ca/en/products/optimal-use/warfarin-management/feedback-now-open

Announcement: The latest issue (April-June 2011) of British Columbia-based Therapeutics Initiative’s Therapeutics Letter features CADTH’s work, recommendations, and key messages on the self-monitoring of blood glucose (SMBG).
http://www.cadth.ca/en/media-centre/2011/cadth-work-highlighted-in-article-on-self-monitoring

 

~~~~~

 

HEADS UP - September 5, 2011

Notices of Compliance - August 22 - 26, 2011

• Edurant (rilpivirine hydrochloride) was approved as a human immunodeficiency virus (HIV) non-nucleoside reverse transcriptase inhibitor (NNRTI) on 2011-08-23.

News from Health Canada

Health Canada

Report: The report, “Health Canada Quarterly Financial Report - for the quarter ended June 30, 2011”, is available.
http://www.hc-sc.gc.ca/ahc-asc/performance/estim-previs/qfr-rft/june-2011-eng.php

Health Advisory: Wing Quon Enterprises Ltd has initiated a stop sale and is voluntarily recalling a natural health product, Bi Yan Pian (NPN# 80023876) from the Canadian market after the product was found to contain an excessive amount of mercury.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_117-eng.php

Therapeutic Products Directorate (TPD)

Health Care Professionals Advisory

Uromitexan: Health Canada has endorsed important safety information on Uromitexan (mesna injection) 100mg/mL.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/mesna_hpc-cps-eng.php

Consumer Health Advisory

Uromitexan: Health Canada has endorsed important safety information on Uromitexan (mesna injection) 100mg/mL.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2011/mesna_pc-cp-eng.php

Drug and Medical Device Recall Listings: The Drug and Medical Device Recall Listings have been updated.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/index-eng.php

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

Notice of Decision: A Notice of Decision is available for Zytiga.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/nd_ad_2011_zytiga_138343-eng.php

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 1, No. 33 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-vol-1-no-33

 

~~~~~

 

HEADS UP - August 22, 2011

Notices of Compliance- August 15 - 19, 2011

• Incivek (telaprevir) was approved as an antiviral agent on 2011-08-16.

On the Move

• The Canadian Agency for Drugs and Technologies in Health (CADTH) announced the appointment of the expert members to its newly established Canadian Drug Expert Committee.
http://www.cadth.ca/en/media-centre/2011/1-canadian-agency-for-drugs-and-technologies-in-health

News from Health Canada

Health Canada

Health Advisory: Health Canada is informing Canadians about the potential dangers of using fresh donor semen for assisted conception.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2010/2010_218-eng.php

Natural Health Products Directorate (NHPD)

Information Sessions: The Natural Health Products Directorate (NHPD) will hold information sessions in Montreal, Toronto, Vancouver and Halifax concerning proposed changes to the current NHP site licensing model and the Good Manufacturing Practices (GMP) standard for NHPs as well as the information required to be provided at the time a product licence application is submitted. 
www.jptcp.com/files/NHPD_email.Information_Sessions.8.30.2011.pdf

Consultation: The Natural Health Products Directorate (NHPD) is seeking your feedback on changes proposed to the current NHP site licensing model and the Good Manufacturing Practices (GMP) standard for NHPs as well as the information required to be provided at the time a product licence application is submitted. These proposed changes have been outlined in a new Risk-Based Approach to Site Licensing (RBASL) Concept Paper.
http://www.hc-sc.gc.ca/dhp-mps/consultation/natur/consult_rbasl_afrdle_concept-eng.php

http://www.hc-sc.gc.ca/dhp-mps/consultation/natur/rbasl_afrdle_concept-eng.php
(Concept Paper - A New Risk-Based Approach to Site Licensing for Natural Health Products)

Therapeutic Products Directorate (TPD)

Health Care Professionals Advisory

Sprycel: Bristol-Myers Squibb Canada (BMS), in collaboration with Health Canada, would like to inform you of important new safety information regarding reports of serious pulmonary arterial hypertension (PAH) in patients treated with Sprycel (dasatinib).
http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/sprycel_hpc-cps-eng.php

Consumer Health Advisory

Sprycel: Bristol-Myers Squibb Canada (BMS), in collaboration with Health Canada, would like to inform patients and healthcare professionals of important new safety information regarding reports of serious pulmonary arterial hypertension (PAH) in patients treated with Sprycel (dasatinib).
http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2011/sprycel_pc-cp-eng.php

Notice of Decision: A Notice of Decision has been issued for Benlysta.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/nd_ad_2011_benlysta_137699-eng.php

National Interest

Advertising Standards Canada (ASC)

Seminar: Advertising Standards Canada (ASC) is pleased to present an introductory session to the Canadian Code of Advertising Standards on September 28, 2011.
http://www.adstandards.com/en/Events/201109CodeToronto.asp

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 1, No. 32 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-vol-1-no-32

Patented Medicine Prices Review Board (PMPRB)

Voluntary Compliance Undertaking: The Chairperson of the Board accepted a Voluntary Compliance Undertaking (VCU) for Trinipatch.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=222

 

~~~~~

 

HEADS UP - August 15, 2011

Notices of Compliance - August 8 - 12, 2011

• Victrelis Triple (boceprevir, peginterferon alfa-2b, ribavirin) was approved as an antiviral agent on 2011-08-11.

News from Health Canada

Therapeutic Products Directorate (TPD)

Notice to Hospitals

Central Vascular Access Devices: Health Canada has issued important safety information on Central Vascular Access Devices.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/central_vascular-veineux_nth-aah-eng.php

Record of Decisions: A Record of Decisions is available for the June 1, 2011 meeting between Health Canada and Canada's Research-Based Pharmaceutical Companies (Rx&D).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/assoc/2011-06-01-eng.php

Record of Decisions: A Record of Decisions is available for the May 31, 2011 meeting between Health Canada and the Direct Sellers Association (DSA).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/assoc/2011-05-31-eng.php

Notice of Decision: A Notice of Decision has been issued for Edurant.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/nd_ad_2011_edurant_137484-eng.php

Drug and Medical Device Recall Listings: The Drug and Medical Device Recall Listings has been updated.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/index-eng.php

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 1, No. 31 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-vol-1-no-31

 

~~~~~

 

HEADS UP - August 8, 2011

Notices of Compliance - August 1 – 5, 2011

• There were no new NOCs published this week.

News from Health Canada

Natural Health Products Directorate (NHPD)

Record of Decisions: A Record of Decisions is available for the June 15, 2011 meeting between the Natural Health Product Directorate (NHPD) and the Canadian Health Food Association (CHFA).
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/activit/bilat/rod-cr_06-15-11-eng.php

Report: The report entitled, “Status of Applications Quarterly Report - Quarter 1 (Fiscal year 2011-2012)”, is available.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/report-rapport/qar_tri_1-12-eng.php

Therapeutic Products Directorate (TPD)

Notice to Hospitals

Certain Injectable and Inhalational Sterile Drugs Imported from Ben Venue Laboratories Inc.: Health Canada is advising Healthcare Professionals of a potential supply shortage of certain drugs currently available in Canada. The drugs affected are imported into Canada by a small number of companies from the contract manufacturer Ben Venue Laboratories Inc. (BVL) located in Bedford, Ohio, United States.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/ben_ven_nth-aah-eng.php

Report: The report entitled, “Therapeutic Products Directorate: Strategic Plan 2010 - 2014: Moving Forward”, is available.
http://www.hc-sc.gc.ca/dhp-mps/pubs/drug-medic/tpd_stratplan_dpt_planstrat-eng.php

Meeting Summary Report: A Meeting Summary Report is available for the May 31, June 1-2, 2011 meeting of the Expert Advisory Committee on the Vigilance of Health Products (EAC-VHP).
http://www.hc-sc.gc.ca/dhp-mps/medeff/eacvhp-ccvrps/meet-reunion/jun-juin-11-eng.php

Record of Decisions: A Record of Decisions is available for the May 18, 2011 meeting between Health Canada and the Canadian Consumer Specialty Products Association (CCSPA).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/assoc/2011-05-18-eng.php

Notice of Decision: A Notice of Decision is available for the Edwards Sapien Transcatheter Heart Valve.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/md-im/nd_ad_2011_sapien_thv_176966-eng.php

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

Notice: A Notice has been issued regarding the release of the Proposed Revisions to the Guidance Document: Patented Medicines (Notice of Compliance) Regulations.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/announce-annonce/notice_pmnoc_avis_mbac-eng.php

Document: The document, “Procedure - The Release to the Public of Information Obtained from Adverse Reaction and Medical Device Reports”, is available.
http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_guide/2011-procedure/index-eng.php

Document: The document, “Inspection Strategy for Medical Device Companies (POL-0035)”, is available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/info-prod/md-im/pol-0035_insp_strat_doc-eng.php

Document: The document, “Medical Devices: Reviewing the Medical Devices Inspection Cycle – Consultation Workbook Introduction”, is available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/info-prod/md-im/md-im-questionnaire-eng.php

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 1, No. 30 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-vol-1-no-30

Consultation: The Canadian Agency for Drugs and Technologies in Health (CADTH) is undertaking a project on the optimal management of warfarin to prevent stroke and other thromboembolic events in patients with atrial fibrillation.
http://www.cadth.ca/en/products/optimal-use/warfarin-management

~~~~~

HEADS UP - August 1, 2011

Notices of Compliance - July 25 – 29, 2011

• Trajenta (linagliptin) was approved as an Oral Antihyperglycemic Agent: DPP-4 Inhibitor: Incretin Enhancer on 2011-07-28.

• Samsca (tolvaptan) was approved as a Vasopressin V2-Receptor Antagonist on 2011-07-25.

• Victrelis (SCH 503034, boceprevir) was approved as a Hepatitis C Virus (HCV) Protease Inhibitor on 2011-07-29.

• Zytiga (abiraterone acetate) was approved as an Androgen Biosynthesis Inhibitor on 2011-07-27.

News from Health Canada

Health Canada

Health Advisory: Health Canada is informing healthcare practitioners and patients of a labelling update for finasteride drugs to add safety information on rare reports of breast cancer in men.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_110-eng.php

Biologics, Radiopharmaceuticals & Genetic Therapies Directorate (BGTD)

Form: A Human Cells, Tissues and Organs (CTO) For Transplantation Registration Application Form (FRM-0171) is available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/frm_0171-eng.php

Updated List: An updated list of Registered Cells, Tissues and Organs (CTO) Establishments is available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/info-prod/cell/cto-estab-etab-eng.php

Therapeutic Products Directorate (TPD)

Health Care Professional Advisory

Certain Sandoz Products for Injection: Sandoz Canada Inc., in consultation with Health Canada, would like to inform you of possible fading of the expiry date and lot number on the label of certain Sandoz products for injection distributed in vials of 10 mL or less.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/sandoz_prod_hpc-cps-eng.php

Multaq: Sanofi-aventis Canada Inc. in collaboration with Health Canada would like to inform you of important new safety information regarding Multaq® (dronedarone).
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/multaq_2_hpc-cps-eng.php

Consumer Health Advisory

Multaq: Updated safety information is available on Multaq (dronedarone) related to an increase in heart-related events in patients with permanent atrial fibrillation.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2011/multaq_2_pc-cp-eng.php

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

Notice of Compliance with conditions: A Notice of Compliance with conditions (NOC/c) is available for Tasigna.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/tasigna_138440-eng.php

 

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/tasigna_fs_fd_138440-eng.php
(Fact Sheet Tasigna)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/tasigna_dhcpl_lapds_138440-eng.php
(Dear Health Care Professional Letter)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/tasigna_gn_aa_138440-eng.php
(Qualifying Notice)

Strategic Plan: The Therapeutic Products Directorate Strategic Plan 2010-2014 is available.
http://www.hc-sc.gc.ca/dhp-mps/pubs/drug-medic/tpd_stratplan_dpt_planstrat-eng.php

Consultation: The revised Draft Guidance Document entitled, “Preparation of Drug Submissions and Applications in the Common Technical Document (CTD) Format”, is available for comment.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult_ctd_prep_draft_rev_ebauche_nds_2011-eng.php

http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/ctd_prep_draft_rev_ebauche_nds_2011-eng.php
(Consultation Document)

Drug and Medical Device Recall Listings: The Drug and Medical Device Recall Listings have been updated.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/index-eng.php

National Interest

Gazette I

Canadian Environmental Protection Act, 1999: An Order has been issued adding toxic substances to Schedule 1 to the Canadian Environmental Protection Act, 1999.
http://www.gazette.gc.ca/rp-pr/p1/2011/2011-08-06/html/index-eng.html

Canadian Environmental Protection Act, 1999: Proposed Export of Substances on the Export Control List Regulations are available.
http://www.gazette.gc.ca/rp-pr/p1/2011/2011-08-06/html/index-eng.html

 

Canadian Intellectual Property Office (CIPO)

International Patent Classification: A new version of the International Patent Classification (IPC) will come into force January 1, 2012. An early publication of this version is currently available on the World Intellectual Property Office (WIPO) website.
http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr03123.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 1, No. 29 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-vol-1-no-29

 

Patented Medicine Prices Review Board (PMPRB)

Webinar: Michelle Boudreau, Executive Director, delivered a webinar, Canada´s Patented Medicine Prices Review Board, at the Global HTA and CER Forum 2011.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=221

 

~~~~~

 

HEADS UP - July 25, 2011

Notices of Compliance - July 18 - 22, 2011

• There were no new NOCs published this week.

News from Health Canada

Health Canada

Foreign Product Alerts: The following Foreign Product Alerts have been issued.

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-107-eng.php
(Celerite Slimming Tea)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-108-eng.php
(Pink Lady for Women Capsules - St Nirvana Herbal Slimming Capsules)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-109-eng.php
(Hong Kong Department of Health - Fifteen products promoted for weight loss)

Therapeutic Products Directorate (TPD)

Scientific Advisory Committee: The following information is available on the Scientific Advisory Committee on Medical Devices used in Cardiovascular Systems.

http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/sci-com/cardio/sacmducs_tor_ccsmmuac_att-eng.php
(Scientific Advisory Committee on Medical Devices Used in the Cardiovascular System - Terms of Reference)

http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/sci-com/cardio/sacmducs_a_ccsmmuac_o_2010-12-10-eng.php
(Scientific Advisory Committee on Medical Devices used in Cardiovascular System - Agenda - December 10, 2010)

http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/sci-com/cardio/sacmducs_rop_ccsmmuac_crd_2010-12-10-eng.php
(Scientific Advisory Committee on Medical Devices used in Cardiovascular Systems - Record of Proceedings - December 10, 2010)

Report: Health Canada is pleased to announce the release of the Therapeutic Products Directorate Statistical Report 2010 for the Patented Medicines (Notice of Compliance) Regulations and Data Protection.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/docs/patmedbrev/patmrep_mbrevrap_2010-eng.php

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

Notice of Decision: A Notice of Decision has been issued for Banzel.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/nd_ad_2011_banzel_139913-eng.php

Letter: Health Canada has issued a 2012 -Annual Review Drug Establishment Licences (DELS) letter.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/ren-doc/del_ren_lepp-let-eng.php

Form: A Drug Establishment Licence Fee Form is available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/ren-doc/del_fee-frais_form-eng.php

Form: An Emergency Contact Information Form is available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/ren-doc/emergency_urgence_info_form-eng.php

Checklist: A Drug Establishment Licence Application Completion Checklist is available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/ren-doc/del_lepp_checklist_form-eng.php

Letter: Health Canada has issued a letter regarding the Guidance on Evidence to Demonstrate Drug Good Manufacturing Practices (GMP) Compliance of Foreign Sites (GUI-0080) - Current Practices.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/ren-doc/gui-0080_practice_ltr-eng.php

Letter: Health Canada has issued a Letter regarding an Annual Review of Medical Device Establishment Licences (MDELs) for 2012.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/ren-doc/mdel_ren_lepim-let-eng.php

Form: A Medical Device Establishment Licence Fee Form is available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/ren-doc/mdel_fee-frais_form-eng.php

Checklist: A Medical Device Establishment Licence Application Completion Checklist is available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/ren-doc/mdel_leim_checklist_form-eng.php

Notice: Health Canada is pleased to announce that effective immediately Prescribing Information (PI) will be posted to the Health Canada website.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/announce-annonce/pi_notice_ip_avis-eng.php

National Interest

Federal Government

Chemical Substances Challenge: A Notice of intent to amend the Domestic Substances List to apply the Significant New Activity provisions of the Canadian Environmental Protection Act, 1999 to two substances in Batch 4 of the Challenge has been published. The Risk Management Action Milestones table for Batch 4 substances has also been published.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-4/index-eng.php

Chemical Substances Challenge: A Notice of intent to amend the Domestic Substances List to apply the Significant New Activity provisions of the Canadian Environmental Protection Act, 1999 to one substance in Batch 5 of the Challenge has been published. The Risk Management Action Milestones table for Batch 5 substances has also been published.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-5/index-eng.php

Chemical Substances Challenge: The proposed Prohibition of Certain Toxic Substances Regulations, 2012 were published for a 75 day public comment period.
http://www.ec.gc.ca/lcpe-cepa/eng/regulations/detailreg.cfm?intReg=207

Patented Medicine Prices Review Board (PMPRB)

Voluntary Compliance Undertaking: The Chairperson of the Board accepted a Voluntary Compliance Undertaking (VCU) for Sinemet CR.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=220

Report: The National Prescription Drug Utilization System (NPDUIS) has released a new analytical report entitled New Drug Pipeline Monitor – July 2011.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=219

Formulas: The PMPRB has released the Preliminary “Backing-Out” Formulas for Foreign Price Verification.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=218

Newsletter: The PMPRB has released its July 2011 NEWSletter.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=217

 

 

~~~~~

 

HEADS UP - July 18, 2011

Notices of Compliance - July 11 - 15, 2011

• There were no new NOCs published this week.

News from Health Canada

Health Canada

Unauthorized Health Product: Health Canada is advising Canadians that the list of unauthorized health products has been updated to include a new product, "Tibet Babao", which was found to contain undeclared sildenafil, a prescription erectile dysfunction drug.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_104-eng.php

Health Advisory: One bottle of the prenatal multivitamin Centrum Materna has been found to contain unidentified capsules instead of the proper Materna multivitamins, which are pink, oval-shaped tablets.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_102-eng.php

Health Advisory: Health Canada is reviewing the heart-related safety of the prescription drug, Multaq (the brand name for dronedarone).
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_101-eng.php

HPFB Inspectorate

Announcement: Health Canada's Health Products and Food Branch (HPFB) will be holding its third annual International Regulatory Forum in Ottawa, Canada from October 24-28, 2011.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/int/forum/hpfb_dgpsa_notice_avis_forum_2011-eng.php

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/int/forum/hpfb_dgpsa_forum_bio_phar_reg_inscrip_2011-eng.php
(Request for Registration for the 2011 Health Products and Food Branch (HPFB) International Regulatory Forum)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/int/forum/hpfb_dgpsa_forum_pro_2011-eng.php
(Draft Health Products and Food Branch (HPFB) International Regulatory Forum Program)

Natural Health Products Directorate (NHPD)

Reminder: The Natural Health Products Program (NHPP) is reminding product licence holders (including applicants of products with Exemption Numbers (ENs)) of their post-licensing commitments for adverse reaction reporting as set out in section 24 of the Natural Health Products Regulations.
http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_guide/2011-guidance-directrice_reporting-notification/index-eng.php

NHP Advisory Committee and Working Groups: Information is available on the members of the Natural Health Products Program Advisory Committee and Working Groups 2011-2012.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/activit/com/program-mem_list_10-eng.php

Contact Page: The Natural Health Products Directorate contact page has been updated.
http://www.hc-sc.gc.ca/contact/dhp-mps/index-eng.php

Record of Decisions: A Record of Decisions is available for the June 1, 2011 Stakeholder Bilateral meeting between the Natural Health Product Directorate (NHPD) and the Direct Sellers Association (DSA).
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/activit/bilat/rod-cr_06-01-11-eng.php

Therapeutic Products Directorate (TPD)

Health Care Professional Advisory

Calcium Gluconate Injection: Pharmaceutical Partners of Canada Inc. (PPC), in consultation with Health Canada, would like to inform you that aluminum exposure from parenteral nutrition can be associated with serious central nervous system toxicity, bone and liver damage and anemia in vulnerable populations. Calcium Gluconate Injection contains aluminum and is used in parenteral nutrition.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/calcium_gluconate_hpc-cps-eng.php

Notice to Hospitals

Level 1 Normothermic I.V. Fluid Administration Sets equipped with F-50 Gas Vent Filter Assembly: Smiths Medical has made the decision to voluntarily withdraw all lot numbers of Level 1 Normothermic I.V. Fluid Administration Sets equipped with the F-50 Gas Vent Filter Assembly, Product Codes: F-50, DI-65HL, DI-75, DI-150 and DI-350 ("F-50 Disposables") from the market and temporarily suspend all sales of these products. Smiths Medical is conducting this voluntary market withdrawal because of complaints of kinking of the tubing and leaking at the F-50 Gas Vent Filter Assembly ("GVFA").
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/iv_sets-ensembles_nth-aah-eng.php

Final Guidance Document: Health Canada is pleased to announce the release of the final version of the Guidance Document: Medical Device Applications for Implantable Cardiac Leads.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/md_gd_im_ld_cardi_lead_sondes-eng.php

Scientific Advisory Panel: The following information is available on the Scientific Advisory Panel on Bioequivalence Requirements for Gender-Specific Drug Products (SAP-GSDP).

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-consult/gender-sexe/sapgsdp_gcsmss_m_bio-eng.php
(Membership List - Scientific Advisory Panel on Bioequivalence Requirements for Gender-Specific Drug Products (SAP-GSDP))

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-consult/gender-sexe/sapgsdp_ai_gcsmss_ai-eng.php
(Summary of Expertise, Experience and Affiliations and Interests for the Scientific Advisory Panel on Bioequivalence Requirements for Gender-Specific Drug Products (SAP-GSDP))

Report: A report on the Health Canada Workshop on Health Product Plain Language Labelling is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/proj/monograph-rev/workshop_pll_atelier_elc-eng.php

Guidance Document: The Guidance Document, “Drug Establishment Good Manufacturing Practices - Pre-Application Package (Importers, Distributors and Wholesales)”, is available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/docs/gmp-package-bpf-eng.php

Notice: A Notice has been issued to Manufacturers/Sponsors of Nonprescription Drug Products regarding the Emerging Regulatory Requirement for Non-Medicinal Ingredient (NMI) Labelling.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/templates-modeles/notice_nmi_label_avis_inm_etiq-eng.php

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/templates-modeles/nmi_label_att_inm_etiq-eng.php
(Non-Medicinal Ingredients Labelling Attestation Letter Template)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/templates-modeles/faq_nmi_label__inm_etiq-eng.php
(Non-Medicinal Ingredient (NMI) Labelling Regulations: Frequently Asked Questions)

Draft Guidance Document: The Draft Guidance Document, “Product Monograph - Part III: Consumer Information”, is available for comment.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult_draft_pm_ebauche_mp-eng.php

National Interest

Canadian Intellectual Property Office (CIPO)

Document: The document, “The eight IP steps before doing business abroad”, is available.
http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr03115.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 1, No. 28 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-vol-1-no-28

Editorial: The latest issue of International Journal of Technology Assessment in Health Care (Volume 27, Issue 3, Cambridge University Press) features an editorial by CADTH’s Chief Scientist, Dr. Tammy Clifford, highlighting the importance of gender-sensitive approaches to health technology assessment, as well as the challenges.
http://www.cadth.ca/en/media-centre/2011/gender-issues-in-health-technology-assessment-do-as

Pharmaceutical Advertising Advisory Board (PAAB)

Newsletter: The July 2011 issue of the PAAB Review is available.
http://www.paab.ca/local/files/en/newsletter//PAAB%20Review%20Newsletter%2007%202011%20E.pdf
 

 

~~~~~

 

HEADS UP - July 11, 2011

Notices of Compliance - July 4 - 8, 2011

• Benlysta (belimumab) was approved as an immunosuppressant on
2011-07-06.

News from Health Canada

Health Canada

Health Advisory: Health Canada is informing health professionals and consumers that the labelling information for the drug metoclopramide is being updated to include stronger warnings on the risk of a movement disorder known as "tardive dyskinesia."
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_99-eng.php

Consultation: The Consumer and Clinical Radiation Protection Bureau of the Environmental and Radiation Health Sciences Directorate is conducting a national consultation of a new draft Safety Code on Mammography.
http://www.consultations.hc-sc.gc.ca/public-consult/consultations/calendar-calendrier/consultation_e.php?id=622

Biologics, Radiopharmaceuticals & Genetic Therapies Directorate (BGTD)

Summary Basis of Decision: A Summary Basis of Decision (SBD) is available for Cleviprex.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/sbd_smd_2011_cleviprex_125287-eng.php

Therapeutic Products Directorate (TPD)

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

Update on Program Evaluation Request Proposal: CADTH’s Program Evaluation Request Proposal has been updated. Questions submitted by potential bidders will be answered and posted publically to provide the opportunity for all bidders to review.
http://www.cadth.ca/en/media-centre/ekos-evaluation

Patented Medicine Prices Review Board (PMPRB)

Decision: The Federal Court of Canada released its decision in the Pentacel and Quadracel matters.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=216

National Association of Pharmacy Regulatory Authorities (NAPRA)

Consultation: A consultation has been opened regarding the draft updated NAPRA Policy for Natural Health Products.
www.jptcp.com/files/NAPRA_Policy_for_NHP.pdf

Meeting: The next meeting of the National Drug Scheduling Advisory Committee (NDSAC) is scheduled for September 11-12, 2011. http://napra.ca/pages/home/default.aspx?id=2953
 

 

~~~~~

 

HEADS UP -July 4, 2011

Notices of Compliance - June 27 – July 1, 2011

• No new NOCs were published this week.

News from Health Canada

Health Canada

Response to Carlin Jury Recommendations: Health Canada's response to the Carlin Jury Recommendations aimed at the department or directly relevant to its mandate is available.
http://www.hc-sc.gc.ca/ahc-asc/pubs/hpfb-dgpsa/inquest-enquete_carlin-eng.php

Foreign Product Alerts: The following Foreign Product Alerts are available.

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-96-eng.php
(X-Hero - Male Enhancer)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-95-eng.php
(Slim Xtreme Herbal Slimming Capsules)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-94-eng.php
(Natural Vigra VIAGRA Tablets - Satibo Capsules)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-93-eng.php
([Hua Tuo Brand] Youzhi Baoying Dan - [Lee Sze] Texiao Houtong Wan - Prolonged Man Power Essence)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-92-eng.php
(Black Ant)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-91-eng.php
(Beline Capsules)

Health Advisory: Health Canada is advising Canadians that Procter & Gamble is conducting a voluntary recall of "Oral B Anti-Cavity Dental Rinse- Alcohol Free" (NPN 02129930) and "Oral-B Anti-Bacterial with Fluoride - Alcohol Free Daily Use Mouthrinse" (DIN 02130823).
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_97-eng.php

Health Advisory: Health Canada is reminding Canadians, particularly women of child-bearing age, of the risks to children whose mothers take a valproate drug, used to treat epilepsy, while pregnant.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_90-eng.php

Therapeutic Products Directorate (TPD)

Notice of Decision: A Notice of Decision is available for Brilinta.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/nd_ad_2011_brilinta_132218-eng.php

Newsletter: The Canadian Adverse Reaction Newsletter, Volume 21 - Issue 3 - July 2011 is available.
http://www.hc-sc.gc.ca/dhp-mps/medeff/bulletin/carn-bcei_v21n3-eng.php

Calculation Chart: A Medical Device Establishment Licence Fee Calculation Chart is available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/directives/calcul-chart_md-im-eng.php

Document: The document entitled, “Regulation of Health Products Advertising in Canada - Overview for Physicians”, is available.
http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/overview-apercu-eng.php

Document: The document entitled, “Health Products Advertising on Physician Web Sites - Questions and Answers”, is available.
http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/web-qa-qr-eng.php

Scientific Advisory Committee: The following information is available regarding the Scientific Advisory Committee on Metabolic and Endocrine Therapies.

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-com/metabol/sacmet_tor_ccstme_att-eng.php
(Draft Terms of Reference)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-com/metabol/sacmet_ccstme_m_bio-eng.php
(Membership List and Biographies)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-com/metabol/sacmet_ccctme_ai-eng.php
(Summary of Expertise, Experience and Affiliations and Interests)

Scientific Advisory Panel: The following information is available regarding the Scientific Advisory Panel on Bioequivalence Requirements for Gender-Specific Drug Products (GSDP).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-consult/gender-sexe/index-eng.php

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-consult/gender-sexe/sapgsdp_tor_gcsmss_att-eng.php
(Terms of Reference)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-consult/gender-sexe/sapgsdp_gcsmss_m_bio-eng.php
(Membership List)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-consult/gender-sexe/sapgsdp_a_gcsmss_o-eng.php
(June 2, 2011 Meeting – Agenda)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-consult/gender-sexe/sapgsdp_rop_gcsmss_crd_2011-06-02_ati-eng.php
(June 2, 2011 Meeting - Record of Proceedings)

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

Program Evaluation Request for Proposal: CADTH is seeking proposals from contractors to complete Phase I of a four-year program-wide outcomes evaluation.
http://www.cadth.ca/en/media-centre/ekos-evaluation

Patented Medicine Prices Review Board (PMPRB)

Board Order: The Hearing Panel published the board order and its decision on the merits in the matter of ratiopharm Inc.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=215

 

~~~~~

HEADS UP - June 27, 2011

Notices of Compliance - June 20 - 24, 2011

• Banzel (rufinamide) was approved as an antiepileptic on 2011-06-22.

News from Health Canada

Health Canada

Unauthorized Health Products: Health Canada has issued an advisory regarding 14 additional unauthorized health products which may pose serious health risks.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_89-eng.php

Unauthorized Health Product: An unauthorized health product, "Man Up Now", was removed from sale at "O! Behave" retail stores in Delta and Surrey, B.C. after Health Canada's testing identified undeclared sildenafil, a prescription medication in this product.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_88-eng.php

Biologics, Radiopharmaceuticals & Genetic Therapies Directorate (BGTD)

Report: The Biologics and Genetic Therapies Directorate Drug Submission Performance Quarterly Report: January – March 2011 is available.
www.jptcp.com/files/BGTD_DPBTG_11_Q1_ENG_1.pdf

Natural Health Products Directorate (NHPD)

Report: The report: Natural Health Product Tracking Survey – 2010 Final Report is available.
http://epe.lac-bac.gc.ca/100/200/301/pwgsc-tpsgc/por-ef/health/2011/135-09/report.pdf

Therapeutic Products Directorate (TPD)

Report: The Therapeutic Products Directorate Drug Submission Performance Quarterly Report: January – March 2011 is available.
www.jptcp.com/files/TPD_DPT_11_Q1_ENG.pdf

Notice of Decision: A Notice of Decision is available for Jevtana.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/nd_ad_2011_jevtana_137421-eng.php

Consultation: A Consultation is available regarding the release of the draft (Step 2) International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance: Q11: Development and Manufacture of Drug Substance.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult_q11_step2_notice_etape2_avis-eng.php

http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/q11_step2_notice_etape2_avis-eng.php
(Consultation Document)

Consultation: A Consultation is available on draft documents for the Post-Market Reporting Compliance (PMRC) Inspection Program.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/docs/pmrc-consult-eng.php

(Draft Documents)

www.jptcp.com/files/PMRC_Guidelines_GUI_0102_en_for_comments.pdf

www.jptcp.com/files/Risk_Classification_of_PMRC_Observations_GUI_0063_En_for_comments.pdf

www.jptcp.com/files/For_Comments_template_e.doc

Update: The Quarterly Update to the Canada Vigilance Online Adverse Reaction Database has taken place.
http://www.hc-sc.gc.ca/dhp-mps/medeff/databasdon/index-eng.php

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

Notice: Health Canada, by this notice, is advising of its intent to implement the ICH guidance: Choice of Control Group and Related Issues in Clinical Trials (E10).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ich/efficac/e10_step4-eng.php

Consultation: A proposal has been made to add to Part I of Schedule F to the Food and Drug Regulations six medicinal ingredients: alitretinoin, its salts and derivatives; aripiprazole and its salts; besifloxacin and its salts; doripenem, its salts and derivatives; saxagliptin and its salts; and sevoflurane.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult_project_projet_1658-eng.php

http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/project_projet_1658-eng.php
(Consultation Document)

Guidance: The new Guidance Document - Medical Device Licence Renewal and Fees for the Right to Sell Licensed Medical Devices is available. This guidance document replaces the August 23, 2005 version of the document Guidance for Industry - Medical Device Licence Renewal.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/md_licren_mm_homren-eng.php

Guidance: Health Canada is pleased to announce the release of the final revised Guidance Document: Notice of Compliance with Conditions (NOC/c).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/compli-conform/noccg_accd-eng.php

National Interest

Federal Government

Chemical Substances Challenge: The draft screening assessment report for 53 substances with High Hazard Potential on the Domestic Substances List and a Notice of intent to amend the Domestic Substances List to apply the Significant New Activity provisions of the Canadian Environmental Protection Act, 1999 to these 53 substances have been published.
http://www.chemicalsubstanceschimiques.gc.ca/plan/approach-approche/nics53-eng.php

Chemical Substances Challenge: The draft screening assessment report for three strains of Pseudomonas aeruginosa and a Notice of intent to amend the Domestic Substances List to apply the Significant New Activity provisions of the Canadian Environmental Protection Act, 1999 have been published.
http://www.chemicalsubstanceschimiques.gc.ca/plan/approach-approche/micro-eng.php

Chemical Substances Challenge: A Notice concerning the final ecological screening assessment report for chlorinated naphthalenes was published and the proposed risk management approach document was also released for a 60-day public comment period.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/naphthalenes-eng.php

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 1, No. 27 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-vol-1-no-27

 

 

~~~~~

 

HEADS UP - June 20, 2011

Notices of Compliance - June 13 - 17, 2011

• Jevtana (cabazitaxel) was approved as an antineoplastic agent/taxane on 2011-06-16.

News from Health Canada

Health Canada

Statement: The Honourable Leona Aglukkaq, Minister of Health, issued a statement on Chronic Cerebrospinal Venous Insufficiency and Multiple Sclerosis.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2011/2011_87-eng.php

Health Advisory: Health Canada is informing Canadians of an ongoing review of the smoking-cessation aid Champix (the brand name for the prescription drug varenicline tartrate) and the possibility of a slightly increased risk of heart-related side effects in patients who have cardiovascular disease.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_84-eng.php

Biologics, Radiopharmaceuticals & Genetic Therapies Directorate (BGTD)

Membership List: The membership list for the Expert Advisory Committee on Cells, Tissues, and Organs is available.
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/activit/com/eaccto-ccecto/memb-eng.php

Natural Health Products Directorate (NHPD)

Report: The NHPD Status of Applications Quarterly Report: Quarter 4 (January 1, 2011 to March 31, 2011) is now available on the NHPD website.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/report-rapport/qar_tri_4-11-eng.php

Meeting: Notes are available for the March 28 and 29, 2011 meeting of the Natural Health Products Program Advisory Committee -Meeting #9.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/activit/com/program-28-03-2011-eng.php

Therapeutic Products Directorate (TPD)

Summary Basis of Decision: A Summary Basis of Decision (SBD) has been issued for Revolade.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/sbd_smd_2011_revolade_123984-eng.php

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 1, No. 26 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-vol-1-no-26

Patented Medicine Prices Review Board (PMPRB)

Compendium of Policies, Guidelines and Procedures: The Board released its annual updated version of the Compendium of Policies, Guidelines and Procedures for 2011 along with its Monitoring and Evaluation Plan for the Major Changes in the Guidelines.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=214

 

~~~~~

 

HEADS UP - June 13, 2011

Notices of Compliance - June 6 - 10, 2011

• There were no new NOCs published this week.

News from Health Canada

Health Canada

Reports: The following Health Canada reports are available.

http://www.tbs-sct.gc.ca/rpp/2011-2012/index-eng.asp?acr=1772
(2011-2012 Report on Plans and Priorities)

http://www.hc-sc.gc.ca/ahc-asc/performance/estim-previs/plans-prior/2011-2012-tpp-ppt-eng.php
(Summary of Three-Year Plan for Transfer Payment Programs (2011-2014))

http://www.hc-sc.gc.ca/ahc-asc/performance/estim-previs/plans-prior/2011-2012-smr-drd-eng.php
(Future-oriented Financial Statements 2011-2012)

http://www.hc-sc.gc.ca/ahc-asc/activit/sus-dur/2011-2014-strateg-eng.php
(Planning for a Sustainable Future: Health Canada's 2011-2014 Sustainable Development Strategy)

Canada Consumer Product Safety Act: The Canada Consumer Product Safety Act came into force on June 20, 2011.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2011/2011_81-eng.php

Marihuana Medical Access Program: To reduce the risk of abuse and exploitation by criminal elements and keep our children and communities safe, the Honourable Leona Aglukkaq, Minister of Health, today announced that the Government of Canada is considering improvements to the Marihuana Medical Access Program.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2011/2011_80-eng.php

Health Advisory: Following an R.C.M.P. seizure of counterfeit Cialis in the Greater Toronto Area, Health Canada is reminding Canadians that unauthorized and counterfeit health products can pose serious risks to their health as they have not been reviewed by the Department for safety, quality, or efficacy.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_83-eng.php

Health Advisory: In light of studies suggesting an increased risk of bladder cancer with the diabetes drug pioglitazone, as well as actions taken by other regulatory agencies, Health Canada is informing healthcare professionals and Canadians that it is undertaking a review of the drug's status.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_79-eng.php

Biologics, Radiopharmaceuticals & Genetic Therapies Directorate (BGTD)

Membership List: The membership list of the Expert Advisory Committee on Blood Regulations (EAC-BR) is available.
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/activit/com/eacbr-ccers/memb-eng.php

Natural Health Products Directorate (NHPD)

Report: The NHPD Report, Status of Applications: Quarter 4 (January 1, 2011 to March 31, 2011) is available.
www.jptcp.com/files/NHPD_2010_2011_Q4_Report_Eng.pdf

Therapeutic Products Directorate (TPD)

Record of Decisions: A Record of Decisions is available for the March 23, 2011 meeting between Health Canada and Consumer Health Products Canada.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/assoc/2011-03-23-eng.php

Consultation: The purpose of this letter is to provide an opportunity to comment on the proposal to add to Part I of Schedule F to the Food and Drug Regulations six medicinal ingredients: amiodarone, its salts and derivatives; azacitidine, its salts and derivatives; certolizumab pegol; cladribine, its salts and derivatives; degarelix, its salts and derivatives; and urokinase.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult_project_projet_1659-eng.php

http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/project_projet_1659-eng.php
(Consultation Document)

Record of Discussions: A Record of Discussions is available for the April 19, 2011 meeting between the Canadian Advertising Preclearance Agencies and Health Canada.
http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/meet-reunion/rod-rdd_2011_04_19-eng.php

Document: The Health Canada document, “Health Canada's role in the Management and Prevention of Harmful Medication Incidents”, is available.
http://www.hc-sc.gc.ca/dhp-mps/medeff/cmirps-scdpim-eng.php

National Interest

Federal Government

Chemical Substances Challenge: On June 18, 2011, the updated draft screening assessment of substances of low concern using the rapid screening approach was published in the Canada Gazette, Part I.
http://www.chemicalsubstanceschimiques.gc.ca/plan/approach-approche/rapid-eng.php

Chemical Substances Challenge: The Risk Management Action Milestones table for Batch 3 substances has been published.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-3/risk-risque-eng.php

Chemical Substances Challenge: The Government of Canada published a Notice of intent to address a class of approximately 350 aromatic azo- and benzidine-based substances. The Notice of intent indicates that the Government of Canada plans to assess the potential health and ecological risks of these substances.
http://www.chemicalsubstanceschimiques.gc.ca/plan/approach-approche/azo_benzidine-eng.php

Gazette I

Canadian Environmental Protection Act, 1999: Publication after screening is available for the assessment of 545 substances specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999).
http://www.gazette.gc.ca/rp-pr/p1/2011/2011-06-18/html/index-eng.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 1, No. 25 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-vol-1-no-25

Patented Medicine Prices Review Board (PMPRB)

Annual Report: The PMPRB’s 2010 Annual Report was tabled before Parliament on June 16, 2011.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=213

Presentation: Michelle Boudreau, Executive Director, delivered a presentation at the Drug Pricing & Reimbursement in Canada conference in Toronto on June 14, 2011.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=212

Canadian Institutes of Health Research (CIHR)

Report: The report, Summary of Pharmaceutical Survey Findings on R&D Spending and Investments by Rx&D Members – 2010, is available.
http://www.cihr-irsc.gc.ca/e/43779.html

 

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HEADS UP - June 6, 2011

Notices of Compliance - May 30 – June 3, 2011

• Brilinta (ticagrelor) was approved as a platelet aggregation inhibitor on 2011-05-30.

News from Health Canada

Health Canada

Health Advisory: Health Canada is informing healthcare professionals and consumers that the prescribing information for the entire class of antipsychotic drugs is being updated. The updated labelling will contain safety information on the potential risk of abnormal muscle movements and withdrawal symptoms in newborns whose mothers were treated with these drugs during the third trimester of their pregnancy.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_78-eng.php

Unauthorized Health Products: A number of unauthorized health products, including sexual enhancement products, that may pose serious risks to the health of Canadians were removed from sale at Male and Female Harmony retail stores in Richmond and Burnaby, B.C., along with the Happy Paradise Adult Store in Burnaby.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_77-eng.php

Therapeutic Products Directorate (TPD)

Reminder: On March 25, 2011, Health Canada posted a Notice to Stakeholders on its web site inviting them to participate in the new Active Pharmaceutical Ingredients Survey (API) - Activities Conducted with Respect to Drugs for Human Use. This is a reminder to please complete the survey if you have not already done so.
www.jptcp.com/files/Final_API_Stakeholders_Survey_2011_03_25_Eng.doc

Annual Drug Notification Package: The Annual Drug Notification Package is available.
www.jptcp.com/files/Annual_Package_2011_eng.pdf

Consultation: The Draft Guidance Document: Guidance on supporting evidence to be provided for new and amended licence applications for Class III and Class IV medical devices, not including In Vitro Diagnostic Devices (IVDDs), is available for consultation.
http://www.hc-sc.gc.ca/dhp-mps/consultation/md-im/consult_md_draft_gd_data_im_ebauche_ld_donnees_ciii_civ-eng.php

Record of Proceedings: A Record of Proceedings is available for the March 29, 2011 meeting of the Scientific Advisory Panel on Opioid Analgesic Abuse.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-consult/opioid/sapoaa_rop_gcsaao_crd_2011-03-29-eng.php

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

Mutual Recognition Agreements Updates: Updates are available for Mutual Recognition Agreements.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/int/mra-arm/update-miseajour/index-eng.php

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 1, No. 24 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-vol-1-no-24

 

~~~~~

 

Notices of Compliance - May 23 - 27, 2011

• There were no new NOCs published this week.

News from Health Canada

Health Canada

Health Advisory: Health Canada is advising Canadians that Tanta Pharmaceuticals Inc. is conducting a voluntary recall of all lots of Junior Strength Acetaminophen Tablets 160 mg and Children's Strength Acetaminophen Tablets 80 mg.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_75-eng.php

Health Advisory: Health Canada is informing health professionals and consumers, particularly women, that it is conducting an ongoing safety review of drospirenone-containing oral contraceptives to evaluate the potential for an increased risk of venous thromboembolism (VTE, which are blood clots) relative to other birth control pills.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_74-eng.php

Health Advisory: Taro Pharmaceuticals Canada Inc., in consultation with Health Canada, is voluntarily recalling "Docusate Sodium Capsules USP, 100mg" (Lot # 31040225) from the Canadian market due to possible contamination with the bacterial organism cronobacter (enterobacter) sakazakii.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_73-eng.php

Biologics, Radiopharmaceuticals & Genetic Therapies Directorate (BGTD)

Record of Meeting: A Record of Meeting is available for the March 22, 2010 meeting of the Expert Advisory Committee on Blood Regulation.
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/activit/com/eacbr-ccers/_meet-reunion/mm-crr_2010-03-22-eng.php

Therapeutic Products Directorate (TPD)

Consumer Health Advisory

Rituxan: Hoffmann-La Roche Limited, in consultation with Health Canada, has informed health care professionals of important safety information regarding Rituxan® (rituximab) in Rheumatoid arthritis patients and severe infusion reactions.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2011/rituxan_6_pc-cp-eng.php

Health Care Professional Advisory

Rituxan: Hoffmann-La Roche Limited, in consultation with Health Canada, would like to inform you of important new safety information regarding fatal infusion related reactions following the use of Rituxan® (rituximab) in RA patients.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/rituxan_6_hpc-cps-eng.php

Medical Device Guidance: Health Canada is pleased to announce the release of the guidance document GD211: Guidance on the Content of Quality Management System Audit Reports.
http://www.hc-sc.gc.ca/dhp-mps/md-im/qualsys/cmdcas_scecim_audit13485_gd211-eng.php

Medical Device Guidance: A Guidance for the Interpretation of Significant Change of a Medical Device is available.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/signchng_modimportante-eng.php

Summary Basis of Decision: A Summary Basis of Decision (SBD) is available for Byetta.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/sbd_smd_2011_byetta_128932-eng.php

Record of Decisions: A Record of Decisions is available for the March 16, 2011 meeting between Health Canada and the Canadian Pharmacists Association.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/assoc/2011-03-16-eng.php

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 1, No. 23 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-vol-1-no-23

Newsletter: The CADTH Communiqué, Volume 1, No. 22 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-vol-1-no-22

Call for Public Members: The Canadian Agency for Drugs and Technologies in Health (CADTH) is accepting applications for the position of Public Member on its new Canadian Drug Expert Committee (CDEC) and health technology Expert Review Panel (for non-pharmaceuticals).
http://www.cadth.ca/en/media-centre/2011/call-for-public-members

 

 

~~~~~

 

HEADS UP - May 23, 2011

Notices of Compliance - May 16 - 20, 2011

• There were no new NOCs published this week.

On the Move

• The National Association of Pharmacy Regulatory Authorities (NAPRA) has a new President. David McLeod, a practicing pharmacist from Prince Edward Island, took over the role of President at the conclusion of the recent NAPRA Board of Directors meeting held on April 3, 2011.
http://napra.ca/Content_Files/Files/NR_New_NAPRA_President_English_June12011_Final.pdf

News from Health Canada

Biologics, Radiopharmaceuticals & Genetic Therapies Directorate (BGTD)

Report: The Biologics and Genetic Therapies Directorate Drug Submission Performance Annual Report: January – December 2010 is available.
www.jptcp.com/files/bgtd_dpbtg_annual_annuel_10_eng.pdf

Report: The Biologics and Genetic Therapies Directorate Drug Submission Performance Quarterly Report: October – December 2010 is available.
www.jptcp.com/files/bgtd_dpbtg_10_q4_eng.pdf

Therapeutic Products Directorate (TPD)

Meeting: A Meeting Summary Report is available for the October 20-21, 2010 meeting of the Expert Advisory Committee on the Vigilance of Health Products.
http://www.hc-sc.gc.ca/dhp-mps/medeff/eacvhp-ccvrps/meet-reunion/oct-oct-10-eng.php

Guidance: The new Guidance Document - Fees for the Right to Sell Drugs is available. This guidance document replaces the document, Authority to Sell Drug Fees, Fee Reductions and Adjustment Requests.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/fees-frais/right_sell_guid_droit_vendre-eng.php

Form: The Right to Sell Drugs Fee Remission Request and Attestation Form is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/form/right_sell_form_droit_vendre-eng.php

Report: The Therapeutic Products Directorate Drug Submission Performance Annual Report: January – December 2010 is available.
www.jptcp.com/files/tpd_dpt_annual_annuel_10_eng.pdf

Report: Therapeutic Products Directorate Drug Submission Performance Quarterly Report: October – December 2010 is available.
www.jptcp.com/files/tpd_dpt_10_q4_eng.pdf

Drug Submission Performance Reports: Information is available on Drug Submission Performance Reports.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/docs/perform-rendement/index-eng.php

Guidance: Health Canada is pleased to announce the release of the final version of the Guidance Document: Information to Be Provided by Manufacturers for the Reprocessing and Sterilization of Reusable Medical Devices.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/md_gd_reprocessing_im_ld_retraitement-eng.php

Drug Notification Form: Instructions are available for the completion of the annual Drug Notification Form - Human and Veterinary Drugs.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/announce-annonce/annual_guide_annuelle-eng.php

List of Registrars: The list of registrars recognized by Health Canada under section 32.1 of the Medical Devices Regulations (MDR) has been updated.
http://www.hc-sc.gc.ca/dhp-mps/md-im/qualsys/list_liste_regist-eng.php

Information Sessions: Health Canada is pleased to invite you to a one-day information session on the Medical Device Program (MDP) to take place across the country during the months of September and October, 2011.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/info-prod/md-im/md-im_session_ltr-eng.php

National Interest

Patented Medicine Prices Review Board (PMPRB)

Decision: The Hearing Panel published its decision on the merits in the matter of ratiopharm Inc. and the medicine ratio-Salbutamol HFA.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=211

Health Council of Canada (HCC)

Report: The Health Council of Canada has released the report entitled, “Progress Report 2011: Health care renewal in Canada”.
http://healthcouncilcanada.ca/en/index.php?page=shop.product_details&flypage=shop.flypage&product_id=137&category_id=16&manufacturer_id=0&option=com_virtuemart&Itemid=170

Canadian Generic Pharmaceutical Association (CGPA)

Report: The report entitled, “Innovation for A Better Tomorrow: A Critique”, is available.
http://www.canadiangenerics.ca/en/news/may_30_11.asp
 

 

~~~~~

 

HEADS UP - May 16, 2011

Notices of Compliance - May 9 - 13, 2011

• There were no new NOCs published this week.

News from Health Canada

Health Canada

Health Advisory: Following a release issued by the United States Food and Drug Administration (FDA), Health Canada and the Public Health Agency of Canada are advising parents, caregivers and healthcare providers not to feed "Simply Thick" to premature infants.
http://www.phac-aspc.gc.ca/alert-alerte/advisory-avis_20110520-eng.php

Information Sessions: Health Canada will be holding Information Sessions for Industry on changes to the Canada Consumer Product Safety Act, which come into force on June 20th, 2011.
http://surveys-sondages.hc-sc.gc.ca/s/ccpsa-infosession-lcspc-seanceinfo-eng/

Therapeutic Products Directorate (TPD)

Notice to Hospitals

Non-Sterile Boston Scientific Devices: Boston Scientific Corporation has issued an alert about a stolen shipment of Endoscopy and Urology / Women's Health medical devices. The labels on these devices state that they are "Sterile"; however, they were stolen prior to being sterilized and are non-sterile. Use of these non-sterile devices may lead to infection.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/device-dispositif_stolen-voles_nth-aah-eng.php

Notice of Decision: A Notice of Decision is available for Cleviprex.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/nd_ad_2011_cleviprex_125287-eng.php

Record of Decisions: A Record of Decisions is available for the February 23, 2011 meeting between Health Canada and Canada's Medical Device Technology Companies (MEDEC).
http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/meet-reunion/2011-02-23-eng.php

Record of Decisions: A Record of Decisions is available for the November 17, 2010 meeting between Health Canada and Canada's Medical Device Technology Companies (MEDEC).
http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/meet-reunion/2010-11-17-eng.php

Notice of Intent: The purpose of this Notice of Intent (NOI) is to provide an opportunity to comment on the revised proposal to amend Part I of Schedule F to the Food and Drug Regulations to add quinine, its salts and derivatives except in oral dosage form that provides 50 mg or less of quinine base per dosage unit or per daily dose.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult_project_projet_1431-eng.php

Notice: Health Canada is pleased to announce an increase in the types of submissions being accepted in the electronic-only filing format for a subset of eCTD submissions.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ctd/ectd/notice_scope_ectd_avis_augm-eng.php

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

Nominations: The deadline has been extended for the Canadian Drug Expert Committee (CDEC) Call for Nominations.
http://www.cadth.ca/en/media-centre/2011/5/18/deadline-extended-canadian-drug-expert-committee-cdec

Nominations: The deadline has been extended for the CADTH Expert Review Panel Call for Nominations.
http://www.cadth.ca/en/media-centre/2011/5/18/deadline-extended-cadth-expert-review-panel-call-for

Website: The Canadian Agency for Drugs and Technologies in Health has unveiled a new website.
http://www.cadth.ca/en/media-centre/2011/5/24/cadth-launches-new-website

 

~~~~~

 

HEADS UP - May 9, 2011

Notices of Compliance - May 2 – 6, 2011

• There were no new NOCs published this week.

News from Health Canada

Biologics, Radiopharmaceuticals & Genetic Therapies Directorate (BGTD)

Meeting: A Record of Decisions is available for the December 15, 2010 meeting between the Nuclear Medicine Alliance and Health Canada.
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/activit/meet-reunion/nma-mm-crr-2010-12-15-eng.php

 Meeting: Minutes are available for the March 25, 2011 meeting between Health Canada and BIOTECanada.
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/activit/meet-reunion/biotecanada-mm-crr-2011-03-25-eng.php

Therapeutic Products Directorate (TPD)

Electronic Submissions Reminder: Health Canada would like to remind sponsors not to include credit card, wire, or cheque payment information within electronic submissions.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/announce-annonce/notice_finance_avis-eng.php

Record of Decisions: A Record of Decisions is available for the February 16, 2011 meeting between Health Canada and the Canadian Cosmetic, Toiletry and Fragrance Association (CCTFA).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/assoc/2011-02-16-eng.php

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

Summary Basis of Decision: A Summary Basis of Decision (SBD) is available for Rapaflo.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/sbd_smd_2011_rapaflo_121740-eng.php

National Interest

Advertising Standards Canada (ASC)

Newsletter: The Spring 2011 issue of enews is available.
http://adstandards.com/en/ASCLibrary/newsletters/spring2011/newsletter_ASCNews.aspx

Canadian Intellectual Property Office (CIPO)

Memorandum of Understanding: CIPO and the Instituto Nacional da PI (INPI) from Brazil signed a Memorandum of Understanding.
http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr03026.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: CADTH Communiqué, Volume 1, No. 21 is available.
http://www.cadth.ca/index.php/en/cadth/products/cadth-communique-home/cadth-communique-vol-1-no-21

Newsletter: CADTH Communiqué, Volume 1, No. 20 is available.
http://www.cadth.ca/index.php/en/cadth/products/cadth-communique-home/cadth-communique-vol-1-no-20

Report/Guidance: The final report and guidance document for the 1.5 Tesla Magnetic Resonance Imaging Scanners Compared with 3.0 Tesla Magnetic Imagining Scanners pilot project have been released.
http://www.cadth.ca/index.php/en/media-centre/2011/05/17/254

Reports: The following reports are available.

http://www.cadth.ca/media/pdf/htis/may-2011/RA0524_BoneMarrowTesting_Final.pdf
(Bone Marrow Testing for Acute and Chronic Leukemias and Lymphomas: Guidelines)

http://www.cadth.ca/media/pdf/htis/may-2011/RB0351_Vasopressors_in_Free_Flap_Surgery_Final.pdf
(Vasopressors in Free Flap Surgery: Clinical Benefits and Harms)

http://www.cadth.ca/media/pdf/htis/may-2011/RB0358_Aerosolized_Bronchodilator_Administration_Final.pdf
(Aerosolized Bronchodilator Administration: Guidelines)

http://www.cadth.ca/media/pdf/htis/may-2011/RA0520_IV_Fluid_Infusion_Final.pdf
(Intravenous Fluid and Medication Administration Infusion in Pediatric Patients: Guidelines)

http://www.cadth.ca/media/pdf/htis/may-2011/RB0366_Guanfacine_for_Hyperactivity_Final.pdf
(Guanfacine for the Treatment of Attention Deficit Hyperactivity Disorder in Pediatric Patients: Clinical Effectiveness)

http://www.cadth.ca/media/pdf/htis/may-2011/RB0359_Surgical_Referrals_Final.pdf
(Surgical Referral and Appropriateness of Surgery: Clinical Evidence, Best Practices and Guidelines)

Patented Medicine Prices Review Board (PMPRB)

Hearings: The Board is seeking comments on its proposed revised Rules of Practice and Procedure for its hearings by June 30, 2011.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=210

http://www.pmprb-cepmb.gc.ca/cmfiles/consultations/NC-Cons-RevRules-may2011-e.pdf
(Revised Rules of Practice and Procedure for Board Hearings)

Voluntary Compliance Undertaking: The Chairperson of the Board accepted a Voluntary Compliance Undertaking (VCU) for Technescan MAG3.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=209

Voluntary Compliance Undertaking: The Chairperson of the Board accepted a Voluntary Compliance Undertaking (VCU) for Niaspan.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=208
 

 

~~~~~

 

HEADS UP - May 2, 2011

Notices of Compliance - April 25 - 29, 2011

• There were no new NOCs published this week.

News from Health Canada

Health Canada

Foreign Product Alerts: The following Foreign Product Alerts have been issued.

http://hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-67-eng.php
(Rock Hard Extreme - Passion Coffee)

http://hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-66-eng.php
(JianBu HuQian Wan)

http://hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-65-eng.php
(Gold Seagull Long Zhi Wan – Venergy)

http://hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-64-eng.php
(Dr. Health Series CM Factor)

Biologics, Radiopharmaceuticals & Genetic Therapies Directorate (BRGD)

Draft Regulations: Health Canada is pleased to announce that the draft Blood Regulations are anticipated to be published in Canada Gazette Part I (CGI) in 2011. The stand-alone Blood Regulations -- under the authority of the Food and Drugs Act -- will contain safety, quality and efficacy requirements with respect to blood for transfusion or for further manufacture.
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/reg-init/blood-sang/blood_notice-sang_avis-eng.php

Therapeutic Products Directorate (TPD)

Health Care Professional Advisory

Cytarabine Injection: Hospira is bringing to your attention the potential for Cytarabine crystallization in certain lots of Cytarabine Injection (DIN: 02126656); 2 g/ 20 mL (100 mg/mL) product currently on the Canadian market.
http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/cytarabine_hpc-cps-eng.php

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

National Interest

Advertising Standards Canada (ASC)

Workshop: Advertising Standards Canada will be holding a Clearance Services Workshop entitled, “Demystifying the Requirements for Direct-to-Consumer Advertising of Prescription Drugs (DTCA Rx) and Direct-to-Consumer Information (DTCI)”.

http://www.adstandards.com/en/Events/201105DrugsToronto.asp
(Toronto)

http://www.adstandards.com/en/Events/201106DrugsMontreal.asp
(Montreal)

Canadian Intellectual Property Office (CIPO)

2011-2012 Business Plan: CIPO's 2011-2012 Business Plan outlines the progress CIPO intends to make in the final year of the five-year Strategic Plan, Moving Forward to Canada's Advantage, and sets the stage for launching the next five-year Strategic Plan. http://www.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr03060.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: CADTH Communiqué, Volume 1, No. 19 is available.
http://www.cadth.ca/index.php/en/cadth/products/cadth-communique-home/cadth-communique-vol-1-no-19

Expert Review Panel: CADTH is accepting nominations of Core Members, including a Chair, for its new Expert Review Panel.
http://www.cadth.ca/index.php/en/media-centre/2011/05/5/250

Canadian Drug Expert Committee (CDEC): CADTH is accepting nominations for Core Members and a Chair for its new drug expert committee.
http://www.cadth.ca/index.php/en/media-centre/2011/05/5/252

Announcement: The Canadian Agency for Drugs and Technologies in Health (CADTH) is pleased to announce its priority areas for 2011-2012.
http://www.cadth.ca/index.php/en/media-centre/2011/05/6/253

Reports: The following reports are available.

http://www.cadth.ca/media/pdf/htis/may-2011/RC0265_Methotrexate_for_Rheumatoid_Arthritis_final.pdf
(Methotrexate for the Treatment of Rheumatoid Arthritis: A Review of the Clinical Evidence)

http://www.cadth.ca/media/pdf/htis/may-2011/RCO268_safety_of_leflunomide_and_methotrexate_Final.pdf
(Safety of Leflunomide and Methotrexate as Combination Therapy for Rheumatoid Arthritis: A Review of the Clinical Evidence)

http://www.cadth.ca/media/pdf/htis/may-2011/RC0264%20-%20Short-acting%20spinal%20anesthetics%20final.pdf
(Short-Acting Spinal Anesthetics for Outpatient Procedures: A Review of the Clinical Evidence and Guidelines)

http://www.cadth.ca/media/pdf/htis/april-2011/RB0353_Alternate_Level_of_Care_Units_Final.pdf
(Alternate Level of Care Units in Medical and Surgical Acute Care Facilities: Clinical Evidence and Guidelines)

http://www.cadth.ca/media/pdf/htis/may-2011/RC0262_Central_Monitors_in_Small_Hospitals_Final.pdf
(Central Monitors for Acutely-Ill Cardiac Patients in a Small, Rural Hospital Setting: A Review of Clinical and Cost-Effectiveness)

http://www.cadth.ca/media/pdf/htis/may-2011/RC0261-000_-_CADDRA_Guidelines_on_ADHD_Final.pdf
(Quality Assessment of the Canadian Attention Deficit Hyperactivity Disorder Resource Alliance ADHD Practice Guidelines for Children, Adolescents and Adults with ADHD)

http://www.cadth.ca/media/pdf/htis/may-2011/RB0352_Zopiclone_Final.pdf
(Safety of Zopiclone for Insomnia: Comparative Safety)

http://www.cadth.ca/media/pdf/htis/may-2011/RB0354_EpinephrineDosing_Final.pdf
(Higher than Recommended Doses of Epinephrine for Patients with an Allergic Reaction: Clinical Evidence and Safety)

http://www.cadth.ca/media/pdf/htis/may-2011/RA0522_Electronic_Beds_for_Pediatric_Patients_Final.pdf
(Electronic Beds for Pediatric Patients: Safety)

http://www.cadth.ca/media/pdf/htis/may-2011/RC0267_Best_Practice_Tools_Final.pdf
(Screening and Assessment Tools for Patients with Chronic Disease in Therapeutic Exercise Program: A Review of the Clinical Evidence and Guidelines)

Canadian Institute for Health Information (CIHI)

Report: The CIHI has released the report entitled, “Drug Expenditure in Canada, 1985 to 2010”.
http://secure.cihi.ca/cihiweb/products/drug_expenditure_2010_en.pdf
 

 

~~~~~

 

HEADS UP - April 25, 2011

Notices of Compliance - April 18 - 22, 2011

• There were no new NOCs published this week.

On The Move

• The Minister of Health recently announced the appointments of Mary Catherine Lindberg as Chairperson of the Patented Medicine Prices Review Board and Dr. Mitchell Levine as Vice-Chairperson.

http://www.pmprb-cepmb.gc.ca/english/view.asp?x=1437&mid=1308

• Advertising Standards Canada has announced its 2011/2012 Board of Directors.

http://www.adstandards.com/en/MediaAndEvents/2011BoardOfDirectorsPressRelease.aspx

News from Health Canada

Health Canada

Health Advisory: Omega Alpha Pharmaceuticals Inc., in consultation with Health Canada, is voluntarily recalling all lots of "Omega Alpha Kidney Flush" due to the omission of cautionary and warning statements on the product label.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_63-eng.php

Health Advisory: A list of recalled Health Products manufactured by the Triad Group is available.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_61pl-eng.php

Therapeutic Products Directorate (TPD)

Consumer Health Advisory

Anzemet: New data show that the injectable form of Anzemet® can potentially increase the risk of abnormal heart rhythm which may result in serious cardiac problems at the doses recommended for the prevention of nausea and vomiting.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2011/anzemet_pc-cp-eng.php

Health Care Professional Advisory

Anzemet: Sanofi-aventis Canada Inc., in collaboration with Health Canada, would like to inform you of the withdrawal of Anzemet® (dolasetron mesylate) intravenous injection as it is no longer indicated to prevent nausea and vomiting in adults undergoing chemotherapy.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/anzemet_hpc-cps-eng.php

MedEffect Canada Initiative: Information is available on the MedEffect Canada Initiative, the Public Interface to Post-Market Surveillance Programs and Information.
http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_fs-if/2011-medeff-canada/index-eng.php

Document: The Health Canada document entitled, “Canada Vigilance Program - Collecting and Assessing Adverse Reaction Reports”, is available.
http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_fs-if/2011-cvp-pcv/index-eng.php

Document: The Health Canada document entitled, “Risk Communication - Protecting Canadians through Information”, is available.
http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_fs-if/2011-risk_comm_risque/index-eng.php

Document: The Health Canada document entitled, “The Canadian Adverse Reaction Newsletter - Keeping Health Professionals Informed”, is available.
http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_fs-if/2011-carn-bcei/index-eng.php

Document: The Health Canada document entitled, “Regulating Advertising of Health Products”, is available.
http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_fs-if/2011-advert-publicite/index-eng.php

Expert Advisory Committee on the Vigilance of Health Products: Information is available on the Expert Advisory Committee on the Vigilance of Health Products.
http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_fs-if/2011-eac-vhp-cce-vps/index-eng.php

Summary Basis of Decision: A Summary Basis of Decision (SBD) was issued for Nucynta CR.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/sbd_smd_2011_nucynta_cr_133167-eng.php

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 1, No. 18 is available and contains a Common Drug Review Update.
http://www.cadth.ca/index.php/en/cadth/products/cadth-communique-home/cadth-communique-vol-1-no-18

Newsletter: The May 4, 2011 issue of the Common Drug Review Update — Issue 75 is available. A Pilot Process for Filing Pre-submission Information and changes to CDR Submission Guidelines for Manufacturers are among the topics discussed.
http://www.cadth.ca/index.php/en/cdr/cdr-update/cdr-update-issue-75

Reports: The following reports are available.

http://www.cadth.ca/media/pdf/htis/april-2011/RA0521_PreOp_Markings_Final.pdf
(Pre-Operative Surgical Site Markings for Elective Surgical Patients: Guidelines)

http://www.cadth.ca/media/pdf/htis/april-2011/RA0523_Cochlear_Implant_Upgrades_Final.pdf
(Speech Processor Upgrades in Pediatric Patients with Cochlear Implants: Clinical Evidence and Guidelines)

http://www.cadth.ca/media/pdf/htis/april-2011/L_0258_Technegas_Final.pdf
(Ventilation/Perfusion scintigraphy (using Technegas) versus Computed Tomography Pulmonary Angiography for the Diagnosis of Pulmonary Embolism in Hospitalized Patients: A Review of the Clinical and Cost-Effectiveness)

http://www.cadth.ca/media/pdf/htis/april-2011/RB0355_Patient_Transport_from_Tertiary_Care_Final.pdf
(Patient Transport from Tertiary Care: Guidelines and Recommendations)

http://www.cadth.ca/media/pdf/htis/april-2011/L0259_MALDI-TOF_Final.pdf
(MALDI-TOF Mass Spectrometry for Bacterial Species Identification: A Review of Diagnostic Accuracy and Clinical and Cost-Effectiveness)

http://www.cadth.ca/media/pdf/htis/april-2011/RC0275_Makoplasty_Final.pdf
(MAKO’s RESTORIS Implants and MAKOplasty Procedure for Early to Mid-Stage Osteoarthritic Knee Disease: A Review of the Clinical and Cost-Effectiveness and Safety)

http://www.cadth.ca/media/pdf/htis/april-2011/RB0353_Alternate_Level_of_Care_Units_Final.pdf
(Alternate Level of Care Units in Medical and Surgical Acute Care Facilities: Clinical Evidence and Guidelines)

http://www.cadth.ca/index.php/en/hta/reports-publications/environmental-scans/environmental-scans-20
(Issue 20 - An Update on the Investigation of Chronic Cerebrospinal Venous Insufficiency for the Treatment of Multiple Sclerosis)

Patented Medicine Prices Review Board (PMPRB)

Newsletter: The PMPRB has released its April 2011 NEWSletter.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=207

 

~~~~~

 

HEADS UP - April 18, 2011

Notices of Compliance - April 11 - 15, 2011

• Cleviprex (clevidipine) was approved as an antihypertensive agent on 2011-04-15.

On the Move

• Dr. Brian O’Rourke has been appointed President and Chief Executive Officer of the Canadian Agency for Drugs and Technologies in Health, effective April 1, 2011.
http://www.cadth.ca/index.php/en/media-centre/2011/04/21/249

News from Health Canada

Health Canada

Health Advisory: Following potential bacterial contamination or inadequate sterilization of products in the United States, the Triad Group, including their Canadian importers and distributors, have voluntarily initiated a series of recalls of a number of products used by consumers throughout North America.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_61-eng.php

Biologics, Radiopharmaceuticals & Genetic Therapies Directorate (BRGD)

Food and Drug Regulations: Regulations amending the Food and Drug Regulations (1319 - New Drugs for Extraordinary Use) are available.
http://canadagazette.gc.ca/rp-pr/p2/2011/2011-04-13/html/sor-dors88-eng.html

Patented Medicines Regulations: Regulations amending the Patented Medicines (Notice of Compliance) Regulations are available.
http://canadagazette.gc.ca/rp-pr/p2/2011/2011-04-13/html/sor-dors89-eng.html

Therapeutic Products Directorate (TPD)

Notice: Health Canada has released a notice regarding the interim approach for evaluating cardiovascular risk for new antidiabetic therapies to treat Type 2 Diabetes Mellitus.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/notice_diabet_avis-eng.php

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué — Volume 1, No. 17 is available.
http://www.cadth.ca/index.php/en/cadth/products/cadth-communique-home/cadth-communique-vol-1-no-17

Environmental Scan: The Environmental Scan entitled, “Issue 18 - Drug Supply Disruptions”, is available.
http://www.cadth.ca/index.php/en/hta/reports-publications/environmental-scans/environmental-scans-18

Environmental Scan: The Environmental Scan entitled, “Issue 19 - Funding of Laboratory Testing in Canada”, is available.
http://www.cadth.ca/index.php/en/hta/reports-publications/environmental-scans/environmental-scans-19

National Association of Pharmacy Regulatory Authorities (NAPRA)

Meeting: The proposed meeting of the National Drug Scheduling Advisory Committee for June 12-13, 2011 is cancelled. The next meeting of the Committee is scheduled for September 11-12, 2011. The deadline to receive submissions for a drug scheduling application for this meeting is by end of day Wednesday, July 13, 2011.
http://napra.ca/pages/home/default.aspx

Final Recommendation: The Initial Recommendation made by the National Drug Scheduling Advisory Committee (NDSAC) on March 6, 2011 for the scheduling of:

-Naproxen sodium 220 mg per oral dosage unit (when sold in products labelled with a recommended maximum daily dose of 440 mg, and in package sizes exceeding 6,600 mg) - Schedule III (from Schedule II)

was finalized effective April 21, 2011. Final approval of the Initial Recommendation was made by NAPRA's Executive Committee, in consideration of comments received during the 30-day review period. The National Drug Schedules will be revised accordingly.
http://napra.ca/pages/home/default.aspx?id=2923

~~~~~

 

HEADS UP - April 11, 2011

Notices of Compliance - April 4 - 8, 2011

• There were no new NOCs published this week.

News from Health Canada

Health Canada

Health Advisory: Health Canada is reminding Canadians, including parents and caregivers, about health risks associated with the use of topical benzocaine products, including a rare but potentially serious blood condition known as methemoglobinemia (MetHb).
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_59-eng.php

Health Advisory: Health Canada testing of samples of “Mary Ginseng House 100% Pure High Calibre Pow Sum Ontario Ginseng,” identified the presence of microbial contamination that may pose a health risk to immune-compromised individuals.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_58-eng.php

Therapeutic Products Directorate (TPD)

Consumer Health Advisory

Vivaglobin: CSL Behring Canada Inc, in collaboration with Health Canada, would like to inform you of reports of serious thrombotic events (blood clots) following the use of Vivaglobin®, Immune Globulin Subcutaneous (Human).
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2011/vivaglobin_pc-cp-eng.php

Health Care Professional Advisory

Vivaglobin: CSL Behring Canada Inc, in collaboration with Health Canada, would like to inform you of post-marketing reports that indicate an association of serious thrombotic events with the use of Vivaglobin®, Immune Globulin Subcutaneous (Human).
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/vivaglobin_hpc-cps-eng.php

Notice of Decision: A Notice of Decision has been issued for Gilenya.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/nd_ad_2011_gilenya_137516-eng.php

Newsletter: The Canadian Adverse Reaction Newsletter, Volume 21 - Issue 2 - April 2011 is available.
http://www.hc-sc.gc.ca/dhp-mps/medeff/bulletin/carn-bcei_v21n2-eng.php

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué — Volume 1, No. 16 is available.
http://www.cadth.ca/index.php/en/cadth/products/cadth-communique-home/cadth-communique-vol-1-no-16

Reports: The following reports are available.

http://www.cadth.ca/media/pdf/htis/april-2011/K0341_Transitional_Care_Units_final.pdf
(Transitional Care Units for Patients Awaiting Alternative Care: Comparative Clinical and Cost Effectiveness)

http://www.cadth.ca/media/pdf/htis/april-2011/K0343_Optimal_Caseload_for_Salaried_Physicians_Final.pdf
(Salaried Physicians for Family Practice Caseload: Guidelines)

http://www.cadth.ca/media/pdf/htis/april-2011/RB0344_Patient_Wait_Time_Monitors_Final.pdf
(Patient Wait Time Monitors: Clinical Evidence)

http://www.cadth.ca/media/pdf/htis/april-2011/RB0346_Home_Dialysis_Final.pdf
(Combination of Home-Based Hemodialysis and Peritoneal Dialysis: Clinical Evidence)

http://www.cadth.ca/media/pdf/htis/april-2011/RB0348_Management_of_Calciphylaxis_in_ESRD_Final.pdf
(Management of Calciphylaxis in Adult Patients with End-Stage Renal Disease: Evidence for Optimal Therapy and Guidelines)

http://www.cadth.ca/media/pdf/htis/april-2011/L0257_FES_ChildrenCerebralPalsy_final.pdf
(Functional Electrical Stimulation (FES) for Children with Cerebral Palsy: Clinical Effectiveness)

http://www.cadth.ca/media/pdf/htis/april-2011/RB0347_Glucose_Gel_Final.pdf
(Glucose Preparations for the Treatment of Mild to Moderate Hypoglycemia in Diabetic Patients: Clinical Effectiveness and Guidelines)

http://www.cadth.ca/media/pdf/htis/april-2011/RB0345_Spine_Board_Removal_Final.pdf
(Removal of Spine Boards Prior to X-Ray Clearance for Patients in the Emergency Department: Clinical Evidence and Guidelines)

Pharmaceutical Advertising Advisory Board (PAAB)

Newsletter: The April 2011 issue of the PAAB Review is available.
http://www.paab.ca/local/files/PAAB%20Review%20Newsletter%20April%202011%20E.pdf

Patented Medicine Prices Review Board (PMPRB)

Voluntary Compliance Undertaking: The Chairperson of the Board has accepted a Voluntary Compliance Undertaking (VCU) for Suprane.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=206

 

~~~~~

HEADS UP - April 4, 2011

Notices of Compliance - March 28 – April 1, 2011

• There were no new NOCs published this week.

News from Health Canada

Health Canada

Health Advisory: "U-Prosta Natural support for prostate health" is being voluntarily recalled in Canada by Sunnylife International Inc. after the U.S. Food and Drug Administration (FDA) found the product contains undeclared terazosin hydrochloride, which is a prescription drug used to treat high blood pressure and enlargement of the prostate gland, and could cause serious health effects.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_54-eng.php

Therapeutic Products Directorate (TPD)

Notice to Hospitals

Rusch Irrigation Trays: A recall has been issued for Rusch Irrigation Trays due to the potential contamination of alcohol prep pads co-packaged with RUSCH Irrigation Tray with Piston Catalogue Number 67890 and RUSCH Irrigation Tray with Bulb Catalogue Number 68895.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/rusch_irrigation_tray-plateau_nth-aah-eng.php

National Interest

Gazette II

Financial Administration Act: Regulations amending the Authority to Sell Drugs Fees Regulations are available.
http://www.gazette.gc.ca/rp-pr/p2/2011/2011-04-13/html/sor-dors80-eng.html

Financial Administration Act: Regulations amending the Establishment Licensing Fees Regulations (1056) are available.
http://www.gazette.gc.ca/rp-pr/p2/2011/2011-04-13/html/sor-dors84-eng.html

Financial Administration Act: Fees in respect of Drugs and Medical Devices Regulations are available.
http://www.gazette.gc.ca/rp-pr/p2/2011/2011-04-13/html/sor-dors79-eng.html

Food and Drugs Act: Regulations amending the Food and Drug Regulations are available.
http://www.gazette.gc.ca/rp-pr/p2/2011/2011-04-13/html/sor-dors81-eng.html

Food and Drugs Act: Regulations amending the Food and Drug Regulations (1319 — New Drugs for Extraordinary Use) are available.
http://www.gazette.gc.ca/rp-pr/p2/2011/2011-04-13/html/sor-dors88-eng.html

Food and Drugs Act: Regulations amending the Food and Drug Regulations (1624 — Schedule F) are available.
http://www.gazette.gc.ca/rp-pr/p2/2011/2011-04-13/html/sor-dors93-eng.html

Financial Administration Act: Regulations amending the Licensed Dealers for Controlled Drugs and Narcotics Fees Regulations (1056) are available.
http://www.gazette.gc.ca/rp-pr/p2/2011/2011-04-13/html/sor-dors83-eng.html

Food and Drugs Act: Regulations amending the Medical Devices Regulations are available.
http://www.gazette.gc.ca/rp-pr/p2/2011/2011-04-13/html/sor-dors82-eng.html

Patent Act: Regulations amending the Patented Medicines (Notice of Compliance) Regulations are available.
http://www.gazette.gc.ca/rp-pr/p2/2011/2011-04-13/html/sor-dors89-eng.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué — Volume 1, No. 15 is available.
http://www.cadth.ca/index.php/en/cadth/products/cadth-communique-home/cadth-communique-vol-1-no-15

Reports: The following reports are available.

http://www.cadth.ca/media/pdf/htis/april-2011/J0518%20VTE%20Prophylaxis%20final.pdf
(Venous Thromboembolism Prophylaxis: Clinical Evidence and Guidelines)

http://www.cadth.ca/media/pdf/htis/april-2011/K0340_COPD_Management_in_the_ED_final.pdf
(Clinical Management of Chronic Obstructive Pulmonary Disease in the Emergency Department: Guidelines)

http://www.cadth.ca/media/pdf/htis/april-2011/L0255_Umbilical_Cord_Clamp_Removal_final.pdf
(Umbilical Cord Clamp Removal: Benefits and Harms)

http://www.cadth.ca/media/pdf/htis/april-2011/L_0260_Vent_Covers_final.pdf
(Safety of Air Vents in Psychiatric Units in a Hospital Setting: A Review of the Clinical Evidence and Guidelines)

http://www.cadth.ca/media/pdf/htis/april-2011/RB0349_ESR_Testing_for_Stroke_final.pdf
(Erythrocyte Sedimentation Rate Testing as a Prognostic Indicator for Adult Patients with Transient Ischemic Attack: Clinical Evidence and Guidelines)

National Association of Pharmacy Regulatory Authorities (NAPRA)

Meeting: A meeting of the National Drug Scheduling Advisory Committee (NDSAC) was held on March 6, 2011, with the following Initial Recommendation made:

-Naproxen sodium 220 mg per oral dosage unit (when sold in products labeled with a recommended maximum daily dose of 440 mg, and in package sizes exceeding 6,600 mg) - Schedule III (from Schedule II)

Final approval of NDSAC's Initial Recommendation by NAPRA is deferred until further notice.
http://napra.ca/pages/home/default.aspx?id=2912

Canadian Diabetes Association

Report: The Report entitled, “Diabetes: Canada at the Tipping Point: The Public Perspective; A National Survey”, is available.
http://www.diabetes.ca/documents/get-involved/Environics_survey_report_-_ENGLISH-_Mar_31.pdf

 

~~~~~

 

HEADS UP - March 28, 2011

Notices of Compliance - March 21 - 25, 2011

• There were no new NOCs published this week.

News from Health Canada

Health Canada

Health Advisory: Following a previous communications regarding Probiotic Natural Health Products, Health Canada is updating Canadians on two additional probiotic natural health products found on the Canadian market that are labelled as vegan or not containing dairy (milk) but that may contain trace amounts of milk from ingredients used in the production process.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_53-eng.php

HPFB Inspectorate

Notice: A Notice has been issued regarding important upcoming changes to Establishment Licensing.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/notice-avis_ltr-eng.php

Therapeutic Products Directorate (TPD)

Notice to Hospitals

Bertec Model FLH668NDCM Medical Beds: There has been a recall of Bertec Model FLH668NDCM Medical Beds due to the potential for the head or foot section to drop unexpectedly.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/bertec_beds-lits_nth-aah-eng.php

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

National Interest

Advertising Standards Canada (ASC)

Report: Advertising Standards Canada (ASC) has released its Ad Complaints Report - 2010 Year in Review.
http://www.adstandards.com/en/MediaAndEvents/2010complaintsReportPressRelease.aspx

Canadian Agency for Drugs and Technologies in Health (CADTH)

Reports: The following reports are available.

http://www.cadth.ca/media/pdf/htis/april-2011/J0517_Nursing_Hours_per_Patient_Day_Final.pdf
(Nursing Hours per Patient Day for Paediatric and Maternal Health: Guidelines)

http://www.cadth.ca/media/pdf/htis/april-2011/RA0519_White_Boards_in_the_OR_final.pdf
(White Boards for Transcription of Surgical Counts in the Operating Room: Clinical Effectiveness, Benefits and Harms to Operating Room Patients)

http://www.cadth.ca/media/pdf/htis/april-2011/K0339__Leveliracetam_Treatment_for_Epilepsy_final.pdf
(Levetiracetam Treatment in Patients with Epilepsy: Clinical and Cost-Effectiveness and Safety)

http://www.cadth.ca/media/pdf/htis/march-2011/K0342_Quetiapine_for_Affective_and_PSD_and_BPD_final.pdf
(Quetiapine for Affective and Psychotic Spectrum Disorders and Borderline Personality Disorder: Clinical Effectiveness)

http://www.cadth.ca/media/pdf/htis/march-2011/K0337_Social_Interactions_in_RCF_final.pdf
(Appropriate Social Interactions for Patients in Residential Care Facilities: Guidelines)

http://www.cadth.ca/media/pdf/htis/march-2011/L0252_Audio_screening_final.pdf
(Auditory Screening and Hearing Loss Prevention: Clinical Effectiveness and Guidelines)

http://www.cadth.ca/media/pdf/htis/march-2011/J0515_Heparin_Prophylaxis_final.pdf
(Heparin Prophylaxis for Hospitalized Patients at Risk for Thrombotic Events: Clinical Effectiveness and Safety)

http://www.cadth.ca/media/pdf/htis/march-2011/L0254_Nonstress_Testing_final.pdf
(Non-Stress Testing for Pregnant Adult Diabetics)

http://www.cadth.ca/media/pdf/htis/march-2011/K0336_Rituximab_final.pdf
(Rituximab for the Treatment of Autoimmune Hemolytic Anemia: Clinical Evidence and Guidelines)

http://www.cadth.ca/media/pdf/htis/march-2011/K0335_Aquadex_Flexflow_for_CHF_final.pdf
(Aquadex Flexflow for Patients with Congestive Heart Failure: Clinical and Cost-Effectiveness)

http://www.cadth.ca/index.php/en/hta/reports-publications/environmental-scans/issue-17
(Issue 17: Initiatives for Healthy Aging in Canada)

http://www.cadth.ca/media/pdf/htis/april-2011/K0338_Guidelines_for_Treatment_of_Epilepsy_final.pdf
(Pharmacological Treatments in Patients with Epilepsy: Guidelines)
 

 

~~~~~

 

HEADS UP - March 21, 2011

Notices of Compliance - March 14 - 18, 2011

• There were no new NOCs published this week.

On the Move

• Barb Shea, Vice-President of Products and Services, will be leaving the Canadian Agency for Drugs and Technologies in Health (CADTH) and full-time employment on March 31, 2011.
http://www.cadth.ca/index.php/en/cadth/corporate-profile/executive-news

News from Health Canada

Health Canada

Announcement: The Honourable Leona Aglukkaq, Minister of Health, and the Honourable Rona Ambrose, Minister for Public Works and Government Services and Minister for Status of Women, announced that after an open, fair and transparent bidding process the Government of Canada awarded contracts for the supply of the influenza vaccine for seasonal immunization programs and for use in the case of a pandemic.
http://www.phac-aspc.gc.ca/media/nr-rp/2011/2011_0325-2-eng.php

Document: Health Canada has released the document, ‘It's Your Health - Salvia divinorum’.
http://www.hc-sc.gc.ca/hl-vs/iyh-vsv/life-vie/salvia-eng.php

Biologics, Radiopharmaceuticals & Genetic Therapies Directorate (BRGD)

PSURs/AEFIs: Health Canada's Health Products and Food Branch (HPFB) is informing vaccine market authorization holders (MAH) of its intent to change the reporting process for AEFIs and PSURs for prophylactic vaccines.
http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/notice-avis_vacc-eng.php

Meeting Minutes: Meeting Minutes are available for the May 25, 2010 meeting between Health Canada and BIOTECanada.
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/activit/meet-reunion/biotecanada-mm-crr-2010-05-25-eng.php

Therapeutic Products Directorate (TPD)

Notice to Hospitals

Plum A+ Infusion Pumps Update:  An update to the recall of Plum A+ Infusion Pumps is available.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/plum_infusion_2_nth-aah-eng.php

Plum A+ Infusion Pumps:  Plum A+ Infusion Pumps have been recalled due to audible alarm failure.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/plum_infusion_nth-aah-eng.php

Quarterly Update: The Quarterly Update to the Canada Vigilance Online Adverse Reaction Database has occurred.
http://www.hc-sc.gc.ca/dhp-mps/medeff/databasdon/index-eng.php

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

Consultation: Health Canada invites you to participate in the nation-wide "Active Pharmaceutical Ingredients Survey - Activities Conducted with Respect to Drugs for Human Use".
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/docs/api-ipa_survey-ltr-eng.php

Form: A Class IV Medical Device Licence Amendment Application Form is available.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/md_licam_im_demmhom_cla4-eng.php

Form: A Class III Medical Device Licence Amendment Application Form is available.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/md_licam_im_demmhom_cla3-eng.php

Form: A new Class IV Medical Device Licence Application Form is available.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/licapp_demhom_cla4-eng.php

Form: A new Class III Medical Device Licence Application Form is available.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/licapp_demhom_cla3-eng.php

Form: A new Class II Medical Device Licence Application Form is available.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/licapp_demhom_cla2-eng.php

Q & A: Questions and Answers are available regarding Private Label Medical Devices.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/qalabel_qrmarque_priv-eng.php

Guidance: The Guidance Document: How to Complete the Application for a New Medical Device Licence/Medical Device Licence Amendment for a Private Label Medical Device is available.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/applabel_demmarque_priv-eng.php

Guidance: The Guidance Document - Private Label Medical Devices is available.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/label_marque_pri-eng.php

Form: The Form - Application for a New Medical Device Licence for a Private Label Medical Device is available.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/licapp_demhom_label_marque_npriv-eng.php

Guidance: The Guidance Document - How to Complete the Application for a New Medical Device Licence is available.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/md_gd_licapp_im_ld_demhom-eng.php

Guidance: A  Guidance is available on the Investigation of Reported Medical Device Problems (GUI-0065).
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/prob-report-rapport/gui-0065_md-im_problem_doc-eng.php

Guide: A Guide is available to Recalls of Medical Devices (GUI-0054).
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/prob-report-rapport/gui-0054_recall-retrait-doc-eng.php

Form: The Drug Submission/Application Fee Form has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/form/feef_fraisf-eng.php

Guidance: The Guidance Document - Management of Drug Submissions is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/mgmt-gest/mands_gespd-eng.php

Guidance: The Guidance Document - Fees for the Review of Drug Submission and Applications is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/fees-frais/fee_frais_guide-eng.php

Guidance: The Guidance Document - Fees for Review of Medical Device Licence Applications is available.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/guidedoc_feesmd_docorient_fraisim-eng.php

Fees: New regulations will come into effect on April 1, 2011 regarding fees in respect of Human Drugs and Medical Devices.
http://www.hc-sc.gc.ca/dhp-mps/finance/fees-frais/index-eng.php

National Interest

Gazette I

Food And Drug Regulations: A Notice of Intent has been issued to provide an opportunity for comment on the revised proposal to amend Part I of Schedule F to the Food and Drug Regulations to add quinine, its salts and derivatives except in oral dosage form that provides 50 mg or less of quinine base per dosage unit or per daily dose.
http://www.gazette.gc.ca/rp-pr/p1/2011/2011-03-26/html/index-eng.html

Canadian Intellectual Property Office (CIPO)

Patent Rule: Notice is given that the Governor in Council has approved the Proposed Amendments to the Patent Rules – Expedited Examination of Patent Applications Related to Green Technology. The Rules Amending the Patent Rules came into force on March 3, 2011.
http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr02995.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Consultation: Two draft reports for the pilot project 1.5 Tesla Magnetic Resonance Imaging Scanners compared with 3.0 Tesla Magnetic Resonance Imaging Scanners are available for feedback from all interested stakeholders.
http://www.cadth.ca/index.php/en/media-centre/2011/03/24/246

New Articles: New articles have been released that call on Health Professionals to consider current evidence when recommending self-monitoring of blood glucose.
http://www.cadth.ca/index.php/en/media-centre/2011/03/28/247

Newsletter: The CADTH Communiqué — Volume 1, No. 14 is available.
http://www.cadth.ca/index.php/en/cadth/products/cadth-communique-home/cadth-communique-vol-1-no-14

Newsletter: The CADTH Communiqué — Volume 1, No. 13 is available.
http://www.cadth.ca/index.php/en/cadth/products/cadth-communique-home/cadth-communique-vol-1-no-13

Patented Medicine Prices Review Board (PMPRB)

Voluntary Compliance Undertaking: The Chairperson of the Board accepted a Voluntary Compliance Undertaking (VCU) for Abilify.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=205

Report: The final Report of the DIP Methodology Technical Working Group on the implementation of the Methodology is available.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=204

 

~~~~~

 

HEADS UP - March 7, 2011

Notices of Compliance - February 28 – March 4, 2011

• There were no new NOCs published this week.

News from Health Canada

Therapeutic Products Directorate (TPD)

Health Care Professional Advisory

Ixiaro: Intercell AG and Novartis Pharmaceuticals Canada Inc. (Novartis), in consultation with Health Canada, are asking Canadian health care professionals to immediately stop using lot JEV09L37C of IXIARO® (Japanese Encephalitis vaccine (inactivated, adsorbed)), DIN 02333279, UPC Code 0 63601 18546 0.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/ixiaro_hpc-cps-eng.php

Multaq: Sanofi-aventis Canada Inc. in collaboration with Health Canada, would like to inform you of important new safety information regarding Multaq (dronedarone).
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/multaq_hpc-cps-eng.php

Consumer Health Advisory

Ixiaro: Intercell AG and Novartis Pharmaceuticals Canada Inc. (Novartis), in consultation with Health Canada, are advising people who were vaccinated with one or both doses of lot JEV09L37C of IXIARO® after December 23, 2010, that this specific lot may not provide full protection against Japanese Encephalitis.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2011/ixiaro_pc-cp-eng.php

Multaq: Sanofi-aventis Canada Inc., in collaboration with Health Canada would like to inform patients of new important safety information related to liver injury, reported in patients treated with Multaq.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2011/multaq_pc-cp-eng.php

Summary Basis of Decision: A Summary Basis of Decision (SBD) is available for Daxas.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/sbd_smd_2011_daxas_127683-eng.php

Record of Decisions: A Record of Decisions is available for the November 3, 2010 meeting between Health Canada and Groupement provincial de l'industrie du médicament (GPIM).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/assoc/2010-11-03-eng.php

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

Information Sessions: Health Canada is pleased to invite you to a one-day information session on the Medical Device Program (MDP) to take place across the country during the months of April and May, 2011.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/info-prod/md-im/md-im_session_ltr-eng.php

National Interest

Gazette II

Food and Drug Regulations: Regulations are available amending the Food and Drug Regulations (1627 — Schedule F).
http://www.gazette.gc.ca/rp-pr/p2/2011/2011-03-16/html/sor-dors58-eng.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Reports: The following reports are available.

http://www.cadth.ca/media/pdf/htis/march-2011/J0511_Subcutaneous_Naloxone_final.pdf
(Subcutaneous Naloxone for the Management of Opiate-Induced Constipation and Nausea in Post-Operative Patients: Clinical and Cost-Effectiveness and Guidelines)

http://www.cadth.ca/media/pdf/htis/march-2011/K0332-_Intramuscular_Administration_of_Antipsychotics_final.pdf
(Intramuscular Administration of Antipsychotics: Clinical Effectiveness and Safety)

http://www.cadth.ca/media/pdf/htis/march-2011/J0516_Folic_Acid_and_Prenatal_Vitamins_final.pdf
(Folic Acid and Prenatal Vitamins: Cost-Effectiveness)

Patented Medicine Prices Review Board (PMPRB)

Presentation: Ginette Tognet and Beatrice Mullington of the Regulatory Affairs and Outreach Branch delivered a presentation, Compendium of Policies, Guidelines and Procedures, June 2009 Implementation: January 1, 2010, to a group of Patentees in Montreal on March 2, and in Toronto on March 3.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=202

National Association of Pharmacy Regulatory Authorities (NAPRA)

Newsletter: The Winter 2011 issue of the NAPRA NOTES is available.
http://napra.ca/Content_Files/Files/NAPRA_Notes_Winter_2011.pdf

Meeting: A meeting of the National Drug Scheduling Advisory Committee (NDSAC) was held on March 6, 2011, with the following Initial Recommendation made:

• Naproxen sodium 220 mg per oral dosage unit (when sold in products labeled with a recommended maximum daily dose of 440 mg, and in package sizes exceeding 6,600 mg) - Schedule III (from Schedule II)

Any objections to this Initial Recommendation must be received by the NAPRA office by April 12, 2011.
http://napra.ca/pages/home/default.aspx?id=2894

Health Council of Canada (HCC)

Presentation: Health Council of Canada Chair, Dr. Jack Kitts, accompanied by John G. Abbott, CEO, appeared before the Standing Senate Committee on Social Affairs, Science and Technology on Thursday, March 10, 2011. The Health Council was invited to present a pan-Canadian perspective on the progress made to date on implementing the Ten-Year Plan to Strengthen Health Care.
http://healthcouncilcanada.ca/en/index.php?option=com_content&task=view&id=17&Itemid=22
 

 

~~~~~

 

HEADS UP - February 28, 2011

Notices of Compliance - February 21 - 25, 2011

• There were no new NOCs published this week.

On the Move

• The Patented Medicine Prices Review Board (PMPRB) is pleased to inform its stakeholders of the appointment of Mary Catherine Lindberg as Chairperson and Dr. Mitchell Levine as Vice-Chair of the Board for five-year terms.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=201

• The Honourable Tony Clement, Minister of Industry, announced the appointment of Sylvain Laporte as Commissioner of Patents, Registrar of Trademarks and Chief Executive Officer, Canadian Intellectual Property Office, effective April 16, 2011.
http://www.ic.gc.ca/eic/site/ic1.nsf/eng/06377.html

News from Health Canada

Biologics, Radiopharmaceuticals & Genetic Therapies Directorate (BRGD)

Summary Basis of Decision: A Summary Basis of Decision (SBD) has been issued for Vpriv.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/sbd_smd_2011_vpriv_132604-eng.php

Form: The Human Cells, Tissues and Organs for Transplantation - Error or Accident Investigation Preliminary Report Form (FRM-0172) is available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/info-prod/cell/frm-0172_doc-eng.php

Therapeutic Products Directorate (TPD)

List: The list of registrars recognized by Health Canada under section 32.1 of the Medical Devices Regulations (MDR) has been updated.
http://www.hc-sc.gc.ca/dhp-mps/md-im/qualsys/list_liste_regist-eng.php

Notice: A Notice has been issued regarding publication of an amendment to the Adverse Drug Reaction Reporting Regulations in the Canada Gazette Part II.
http://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hpfb-dgpsa/mhpd-dpsc/amend-reg-eng.php

Guidelines: The Good Manufacturing Practices (GMP) Guidelines - 2009 Edition, Version 2 (GUI-0001) is available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/docs/gui-0001-eng.php

http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/docs/gui-0001-let-eng.php
(Health Canada Letter)

Pre-Inspection Package: Health Canada is pleased to provide you with our new pre-inspection package to assist your organization in complying with Health Canada regulations and preparing for an inspection by the Health Products and Food Inspectorate.
(www.jptcp.com/files/GCP_pre_inspection_v1_en.pdf)

FAQs: Frequently Asked Questions at the GCP Information Sessions are available.
(www.jptcp.com/files/FAQs GCP_Information_Sessions.pdf)

National Interest

Canadian Intellectual Property Office (CIPO)

Annual Report: CIPO’s 2009-10 Annual Report is available.
http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr02994.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Announcement: “Second-line therapy in patients with type 2 diabetes inadequately controlled with metformin monotherapy: A systematic review and mixed treatment comparisons meta-analysis” has been accepted as a wiki article in Open Medicine.
http://www.cadth.ca/index.php/en/media-centre/2011/03/2/242

Reports: The following reports are available.

http://www.cadth.ca/media/pdf/htis/march-2011/J0510_COPD_Management_final.pdf
(Clinical Management of Hospitalized Patients with Chronic Obstructive Pulmonary Disease: Guidelines)

http://www.cadth.ca/media/pdf/htis/march-2011/J0512_Increased_Resource_Allocation_and_LTC_final.pdf
(Increased Resource Allocation and Improved Resident Outcomes in Long-Term Care: Clinical Evidence)

http://www.cadth.ca/media/pdf/htis/march-2011/Quality_Assessment_of_Canadian_ADHD_L2_e.pdf
(Quality Assessment of the CADDRA ADHD Practice Guidelines in Adults with ADHD)

http://www.cadth.ca/media/pdf/htis/march-2011/K0329_Mother_Newborn_Proximity_final.pdf
(Proximity of Mother and Newborn to Enhance Bonding and Recovery Following Cesarean Section: Clinical Evidence and Guidelines)

http://www.cadth.ca/media/pdf/htis/march-2011/K_0330_Back_Care_for_Healthcare_Workers_final.pdf
(Musculoskeletal Injury Prevention Programs for Healthcare Workers: Clinical Effectiveness and Guidelines)

http://www.cadth.ca/media/pdf/htis/march-2011/J0509_Melatonin_for_Adolescents_final.pdf
(Melatonin Treatment for the Management of Insomnia in Adolescents: Clinical Effectiveness and Guidelines)

http://www.cadth.ca/media/pdf/htis/march-2011/K0331_Nasogastric_Tube_In_Situ_final.pdf
(Nasogastric Tube In Situ for Premature Newborns: Comparative Safety of Two Bed Positions and the Benefits of Head of Bed Elevation)

Draft Recommendation: A Draft Recommendation for the Use of Solvent–Detergent-Treated Plasma is available for feedback on the CADTH.
http://www.cadth.ca/index.php/en/new-topics/solvent-detergent-treated-human-plasma/feedback?utm_source=newsletter&utm_medium=webmail&utm_campaign=newsletter-2011-3-9

 

 

~~~~~

 

HEADS UP - February 21, 2011

Notices of Compliance - February 14 - 18, 2011

• There were no new NOCs published this week.

News from Health Canada

Biologics, Radiopharmaceuticals & Genetic Therapies Directorate (BRGD)

Record of Meeting: A Record of Meeting is available for the December 15, 2009 meeting of the Expert Advisory Committee - Cells, Tissues and Organs.
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/activit/com/eaccto-ccecto/rom-crr_2009-12-15-eng.php

Natural Health Products Directorate (NHPD)

eSubmission Builder User Guidance: The eSubmission Builder User Guidance is available.
(www.jptcp.com/files/eSubmission_Builder_User_Guidance_v1_0.pdf)

http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/online-enligne/esb-gde-intro-eng.php
(eSubmission Builder)

Meeting: Notes are available from Natural Health Products Program Advisory Committee Meeting #8 that was held on January 10 and 11, 2011.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/activit/com/program-10-01-2011-eng.php

Therapeutic Products Directorate (TPD)

Notice of Decision: A Notice of Decision has been issued for Revolade.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/nd_ad_2011_revolade_123984-eng.php

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

National Interest

Federal Government – Chemical Substances Challenge

Canadian Environmental Protection Act, 1999: An Order adding toxic substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 for three substances in Batch 4 of the Challenge has been published.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-4/index-eng.php

Canadian Environmental Protection Act, 1999: An Order adding toxic substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 for two substances in Batch 5 of the Challenge has been published.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-5/index-eng.php

Canadian Environmental Protection Act, 1999: A proposed Order adding a toxic substance to Schedule 1 to the Canadian Environmental Protection Act, 1999 for one substance in Batch 10 of the Challenge has been published.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-10/index-eng.php

Canadian Environmental Protection Act, 1999: The proposed Regulations respecting products containing certain substances listed in Schedule 1 to the Canadian Environmental Protection Act, 1999 have been published.
http://www.ec.gc.ca/lcpe-cepa/eng/regulations/detailReg.cfm?intReg=203

Gazette I

Canadian Environmental Protection Act, 1999: An Order has been issued adding a toxic substance to Schedule 1 to the Canadian Environmental Protection Act, 1999.
http://www.gazette.gc.ca/rp-pr/p1/2011/2011-02-26/html/reg5-eng.html

Canadian Environmental Protection Act, 1999: Regulations have been issued respecting products containing certain substances listed in Schedule 1 to the Canadian Environmental Protection Act, 1999.
http://www.gazette.gc.ca/rp-pr/p1/2011/2011-02-26/html/reg4-eng.html

Controlled Drugs And Substances Act: A Notice has been issued that provides interested stakeholders with the opportunity to provide comments on Health Canada’s proposal to add tapentadol, its salts and its related analogues to Schedule I to the Controlled Drugs and Substances Act (CDSA) and to the schedule to the Narcotic Control Regulations (NCR).
http://www.gazette.gc.ca/rp-pr/p1/2011/2011-02-26/html/index-eng.html

Gazette II

Canadian Environmental Protection Act, 1999: An Order has been issued adding toxic substances to Schedule 1 to the Canadian Environmental Protection Act, 1999.
http://www.gazette.gc.ca/rp-pr/p2/2011/2011-03-02/html/sor-dors35-eng.html

 

Canadian Environmental Protection Act, 1999: An Order has been issued adding toxic substances to Schedule 1 to the Canadian Environmental Protection Act, 1999.
http://www.gazette.gc.ca/rp-pr/p2/2011/2011-03-02/html/sor-dors34-eng.html

Medical Device Regulations: Regulations are available amending the Medical Devices Regulations (1592 — Canada’s Access to Medicines Regime).
http://www.gazette.gc.ca/rp-pr/p2/2011/2011-03-02/html/sor-dors42-eng.html

Food and Drug Regulations: Regulations are available amending the Food and Drug Regulations (Adverse Drug Reaction Reporting).
http://www.gazette.gc.ca/rp-pr/p2/2011/2011-03-02/html/sor-dors31-eng.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The March 1, 2011 Issue of the CADTH Communiqué — Volume 1, No. 9 is available.
http://www.cadth.ca/index.php/en/cadth/products/cadth-communique-home/cadth-communique-vol-1-no-9

Reports: The following reports are available.

http://www.cadth.ca/media/pdf/htis/march-2011/L0245_IVIG_Administration_final.pdf
(Management and Patient Safety of IVIG Administration: A Review of Clinical Practice Guidelines)

http://www.cadth.ca/media/pdf/htis/march-2011/K0328_Antipsychotics_and_Pregnancy_final.pdf
(Antipsychotic Use for Pregnant and Nursing Women: Comparative Safety and Optimal Use)

http://www.cadth.ca/media/pdf/htis/march-2011/K0324_Fall_Prevention_Strategies_final.pdf
(Fall Prevention Strategies: Clinical Effectiveness and Guidelines)

http://www.cadth.ca/media/pdf/htis/march-2011/K0327_Antidepressants_and_Pregnancy_final.pdf
(Antidepressant Use for Pregnant and Nursing Women: Comparative Safety and Optimal Use)

http://www.cadth.ca/media/pdf/htis/march-2011/K0325_Thermometers_final.pdf
(Temporal versus Tympanic Thermometers: Ease of Use and Cost-Effectiveness)

http://www.cadth.ca/media/pdf/htis/feb-2011/J0506_Diagnosis_of_ADHD_in_Adults_final.pdf
(Diagnosis of Attention Deficit Hyperactivity Disorder in Adults: Evidence-based Guidelines)

http://www.cadth.ca/media/pdf/htis/feb-2011/K0322_Varenicline_safety_final.pdf
(Varenicline Versus Other Therapy for Patients with Psychiatric Disorders: Comparative Safety and Guidelines)

http://www.cadth.ca/media/pdf/htis/feb-2011/K0326_TRUSP_and_Bacteremia_final.pdf
(Antibiotic Prophylaxis for the Prevention of Bacteremia and Septicemia in Patients Undergoing Transrectal Ultrasound Biopsy: Clinical Effectiveness, Risk Factors, and Guidelines)

Environment Canada

Announcement: The Honourable Peter Kent, Minister of the Environment, and the Honourable Leona Aglukkaq, Minister of Health, today announced the start of a regulatory process to prohibit the manufacture, import, and sale of most mercury-containing products in Canada.
http://www.ec.gc.ca/default.asp?lang=En&n=714D9AAE-1&news=38DACFC5-5B6B-454F-B544-208F88C9320B

Canadian Intellectual Property Council

Report: The report, Innovation for a Better Tomorrow; Closing Canada’s Intellectual Property Gap in the Pharmaceutical Sector, is available.
http://www.chamber.ca/images/uploads/Reports/2011/Innovation_for_a_Better_Tomorrow.pdf
 

 

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HEADS UP - February 14, 2011

Notices of Compliance - February 7 - 11, 2011

• There were no new NOCs published this week.

News from Health Canada

Health Canada

Health Advisory: Following the communication regarding Bowers Medical Ltd. voluntary recall of Triad Group's sterile lubricating jelly, Health Canada is informing Canadians that additional health products have been identified.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_26-eng.php

HPFB Inspectorate

Document: The Health Canada document, ‘Quality System Framework for the Inspectorate Quality Management System (QM-0001) 2011’, is available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/activit/qsf-csq-eng.php

Biologics, Radiopharmaceuticals & Genetic Therapies (BRGD)

Document: The Health Canada document, ‘The Regulation of Vaccines for Human Use in Canada’, is available.
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/activit/fs-fi/vaccin-reg-eng.php

Natural Health Products Directorate (NHPD)

Report: An electronic copy of the Natural Health Products Directorate's Status of Applications Quarterly Report for the period of October 1, 2010 to December 31, 2010 (Quarter 3 of the 2010-2011 fiscal year) is available.
(www.jptcp.com/files/2010_2011_Q3_Report_Eng.pdf).

NHP Online eSubmission Builder: The NHPD document, ‘NHP Online eSubmission Builder’, is available.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/online-enligne/esb-gde-intro-eng.php

Therapeutic Products Directorate (TPD)

Document: The Health Canada document, ‘How to Pay Fees’, is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/costs-couts/crpay_rcfrais_for-eng.php

Document: The Health Canada document, ‘Submission Fee Application Form’, is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/form/feef_fraisf-eng.php

Record of Decision: A Record of Decision is available for the November 10, 2011 meeting between Health Canada and the Canadian Consumer Specialty Products Association (CCSPA).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/assoc/2010-11-10-eng.php

Notice of Decision: A Notice of Decision has been issued for Byetta.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/nd_ad_2011_02_17_byetta_128932-eng.php

Notice of Decision: A Notice of Decision has been issued for Rapaflo.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/nd_ad_2011_rapaflo_121740-eng.php

National Interest

Gazette I

Controlled Drugs and Substances Act: This notice provides interested stakeholders with the opportunity to provide comments on Health Canada’s proposal to add the plant Salvia divinorum (S. divinorum) and its main active ingredient salvinorin A to Schedule III to the Controlled Drugs and Substances Act (CDSA).
http://www.gazette.gc.ca/rp-pr/p1/2011/2011-02-19/html/index-eng.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Reports: The following reports are available.

http://www.cadth.ca/media/pdf/htis/feb-2011/K0315_N95_Fit_Testing_final.pdf
(Denatonium for N95 Respirator Fit Testing: Safety)

http://www.cadth.ca/media/pdf/htis/feb-2011/J0507_Treatment_of_ADHD_in_Adults_final.pdf
(Treatment of Attention Deficit Hyperactivity Disorder in Adults: Evidence-Based Guidelines)

http://www.cadth.ca/media/pdf/htis/feb-2011/L0243_Robotic_Surgery_Artery_Harvesting_final.pdf
(Robotic Surgery versus Open-chest Surgery for Internal Mammary Artery Harvesting and Mitral Valve Surgery: Clinical Effectiveness)
 

 

~~~~~

 

HEADS UP - February 7, 2011

Notices of Compliance- January 31 – February 4, 2011

• There were no new NOCs published this week.

News from Health Canada

Natural Health Products Directorate (NHPD)

Workshop: Health Canada’s Natural Health Products Directorate (NHPD) invites you to participate in a workshop for NHP licence applicants on either March 10 or 11, 2011 in the Burnaby area, British Columbia.
(www.jptcp.com/files/NHPD_Workshop.htm)

User Manual: The Natural Health Products Online Solution: Electronic Product Licence Application Form User Manual is available.
http://www.hc-sc.gc.ca/dhp-mps/pubs/natur/eplaguide-eng.php

Document: The document, “Natural Health Products - Over 43,000 Products authorized for sale and growing’, is available.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/about-apropos/nhp-evolution-psn-eng.php

Document: The document, “Myths and Facts about the Regulation of Natural Health Products in Canada”, is available.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/about-apropos/nhp-myth-psn-eng.php

Therapeutic Products Directorate (TPD)

Notice to Hospitals

Methylene Blue Injectable: Health Canada would like to inform you that cases of serotonin toxicity have been reported and published in association with the use of methylene blue injectable in patients exposed to drugs with serotonin reuptake inhibition properties e.g. selective serotonin reuptake inhibitors (SSRIs).
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/methylene_blue-bleu_nth-aah-eng.php

Consultation: The Draft Guidance Document, Hepatotoxicity of Health Products, is available for comment.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult_draft_ebauche_hepatotox_guide_ld-eng.php

http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/draft_ebauche_hepatotox_guide_ld-eng.php
(Consultation Document)

Record of Decisions: A Record of Decisions is available for the October 25, 2010 meeting between Health Canada and Canada's Research-Based Pharmaceutical Companies (Rx&D).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/assoc/2010-10-25-eng.php

National Interest

Federal Government – Chemical Substances Challenge

Canadian Environmental Protection Act, 1999: An Order adding toxic substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 for four substances in Batch 3 of the Challenge has been published.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-3/index-eng.php

Canadian Environmental Protection Act, 1999: An Order adding toxic substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 for seven substances in Batch 2 of the Challenge has been published.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-2/index-eng.php

Gazette II

Canadian Environmental Protection Act, 1999: Order 2011-87-01-01 has been issued amending the Domestic Substances List.
http://www.gazette.gc.ca/rp-pr/p2/2011/2011-02-16/html/sor-dors29-eng.html

Canadian Environmental Protection Act, 1999: An Order has been issued adding toxic substances to Schedule 1 to the Canadian Environmental Protection Act, 1999.
http://www.gazette.gc.ca/rp-pr/p2/2011/2011-02-16/html/sor-dors26-eng.html

Canadian Environmental Protection Act, 1999: An Order has been issued adding toxic substances to Schedule 1 to the Canadian Environmental Protection Act, 1999.
http://www.gazette.gc.ca/rp-pr/p2/2011/2011-02-16/html/sor-dors25-eng.html

Canadian Intellectual Property Office (CIPO)

Vancouver Group: In 2008, IP Australia, the Canadian Intellectual Property Office and the Intellectual Property Office of the United Kingdom established a number of collaborative projects under the title of the "Vancouver Group". Further information is available on the Vancouver Group.
http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr02959.html

Report: CIPO's Q3 Service Commitments Report is now available.
http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr02953.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Reports: The following reports are available.

http://www.cadth.ca/media/pdf/htis/feb-2011/J0504_Age_Ranges_for_Unmatched_Blood_final.pdf
(Age Ranges for Uncrossmatched Blood Transfusions: Clinical Evidence and Guidelines)

http://www.cadth.ca/media/pdf/htis/feb-2011/L0241_Non-Adherent_Dressings_final.pdf
(Non-Adherent versus Traditional Dressings for Wound Care: Comparative Effectiveness, Safety, and Guidelines)

http://www.cadth.ca/media/pdf/htis/feb-2011/K0313_Oncology_Infusion_Guidelines_final.pdf
(Vital Sign Monitoring During Chemotherapy Infusion: Guidelines)

http://www.cadth.ca/media/pdf/htis/feb-2011/K_0312_Periperhal_SPO2_testing_final.pdf
(Peripheral Pulse Oximetry Measurements as a Positive Predictor of Vital Signs in Adults: Clinical Effectiveness)

http://www.cadth.ca/media/pdf/htis/feb-2011/K0323_CDN_Costs_Hip_Fractures_and_Head_Injuries_final.pdf
(Costs of Hip Fractures and Head Injuries in Canada)

http://www.cadth.ca/media/pdf/htis/feb-2011/K0314_Delay_of_Chemotherapy_final.pdf
(Delay of Chemotherapy Treatments: Guidelines)

http://www.cadth.ca/media/pdf/htis/feb-2011/K0310_Primary_Care_Services_final.pdf
(Location of Primary Care Services: Impact on Clinical Outcomes and Costs)

http://www.cadth.ca/media/pdf/htis/feb-2011/L0244-Pediatric_Supraglottic_Airway_Devices2_final.pdf
(Pediatric Supraglottic Airway Devices: A Review of Clinical Effectiveness)

http://www.cadth.ca/media/pdf/htis/feb-2011/K0319_BCG_Vaccine_Safety_final.pdf
(Bacillus Calmette-Guerin Vaccine Administration for Patients with Bladder Cancer: Safety and Guidelines)

http://www.cadth.ca/media/pdf/htis/feb-2011/L0247-Rosuvastatin_final.pdf
(Comparative Effectiveness of Rosuvastatin Versus Other Statins: A Review of Clinical Effectiveness)

http://www.cadth.ca/media/pdf/htis/feb-2011/K0302_Clopidogrel_and_non-Cardiac_Stents_final.pdf
(Clopidogrel following non-Cardiac Stent Insertion: Clinical Effectiveness and Safety)

http://www.cadth.ca/media/pdf/htis/feb-2011/K0318_Humidifier_L1.5__final.pdf
(Humidifiers in Long-Term Healthcare Settings: Guidelines for Use)

http://www.cadth.ca/media/pdf/htis/feb-2011/L0242_-_Feeding_tube_verification_final.pdf
(Feeding Tube Verification Procedures: Optimal Timing and Guidelines)

Call for Feedback: CADTH has issued a Call for Feedback on The Economic Value of Innovative Health Technologies Discussion Paper.
http://www.cadth.ca/index.php/en/media-centre/2011/02/15/241

Patented Medicine Prices Review Board (PMPRB)

Presentation: Michelle Boudreau, Executive Director, delivered a presentation at the Canadian Healthcare Licensing Association conference in Mont Tremblant, QC on February 10, 2011.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=200
 

 

~~~~~

 

HEADS UP - January 31, 2011

Notices of Compliance- January 24 - 28, 2011

• There were no new NOCs published this week.

News from Health Canada

Health Canada

Voluntary Recall: Health Canada is informing Canadians that Pharmetics Inc., a manufacturer of over the counter drugs, has voluntarily recalled, as a precautionary measure, selected lots of six health products currently on the Canadian market.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_22-eng.php

Health Advisory: Following our communication regarding Copaxone co-packaged in a kit with Triad manufactured recalled alcohol prep pads, Health Canada is informing Canadians that other health products have been identified that are co-packaged with these recalled alcohol prep pads.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_21-eng.php

Foreign Product Alerts: The following Foreign Product Alerts have been issued.

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-18-eng.php
(Fruta Planta Reduce Weight Fruta Planta)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-19-eng.php
(RockHard Weekend (lots 100159 and 100260 sold as blister packs, 3-count bottles and 8-count bottles) and Pandora (lot 100378 sold as blister packs))

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-20-eng.php
(Slimming Factor)

Therapeutic Products Directorate (TPD)

Consumer Health Advisory

Pegetron® Redipen®: Health Canada has endorsed important safety information on Pegetron Redipen (peginterferon alfa-2b).
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2011/pegetron_2_pc-cp-eng.php

Health Care Professional Advisory

Pegetron® Redipen®: Merck Canada Inc., in consultation with Health Canada, would like to inform you of important information regarding the use of Pegetron® Redipen®.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/pegetron_2_hpc-cps-eng.php

Summary Basis of Decision: A Summary Basis of Decision (SBD) is available for Swish Silver Supreme.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/sbd_smd_2010_swish_silver_supreme_121017-eng.php

Guidance: A Guidance Document on the Application for a Certificate of a Pharmaceutical Product (GUI-0024) has been updated.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/directives/gui-0024_doc-eng.php

National Interest

Advertising Standards Canada (ASC)

Newsletter: The ASC has issued the Winter 2011 edition of enews.
http://adstandards.com/en/ASCLibrary/newsletters/winter2011/newsletter_ASCNews.aspx

Canadian Agency for Drugs and Technologies in Health (CADTH)

Reports: The following reports are available.

http://www.cadth.ca/media/pdf/htis/feb-2011/K0307_Sensory_Interventions_for_ASD_final.pdf
(Sensory Integration Theory Interventions for Children with Autism Spectrum Disorders: Clinical Evidence)

http://www.cadth.ca/media/pdf/htis/feb-2011/J_0498_Positive_Attitude_as_a_Determinan_final.pdf
(Positive Attitude as a Determinant of Mental and Physical State: Clinical Effectiveness)

http://www.cadth.ca/media/pdf/htis/feb-2011/K0317_Diabetic_Foot_Complications_final.pdf
(Educational Strategies for Prevention of Diabetic Foot Complications: Clinical Evidence and Guidelines)

Patented Medicine Prices Review Board (PMPRB)

Hearing: The Hearing Panel issued a Board Order in the matter of sanofi-aventis Canada Inc. and the medicine Penlac Nail Lacquer, concluding the proceedings.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=199

 

~~~~~

 

HEADS UP - January 24, 2011

Notices of Compliance - January 17 - 21, 2011

• There were no new NOCs published this week.

News from Health Canada

Health Canada

Foreign Product Alerts: The following Foreign Product Alerts have been issued.

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-12-eng.php
(Aziffa, Erex, Eyeful, Hard Drive, Libidinal, Maxyte, Mojo, Monster Excyte, OMG, OMG45, Prolatis, Red Magic, Size Matters, Stiff Nights, Straight Up, Verect, WOW, Xaitrex, Xytamax, Zilex (with Golden Spear) and Zotrex)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-13-eng.php
(Prolatis' and Duro Extend Capsules for Men)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-14-eng.php
(Tiger King)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-15-eng.php
(Vigor-25, Man Up Now)

Health Advisory: "Exact Multi Greens Powder" and "Exact Multi Greens Capsule" are being voluntarily recalled by Pharmetics Inc. because of an allergy risk to people with milk sensitivities.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_17-eng.php

Health Advisory: Nutrex Research Lipo 6X is being voluntarily recalled from the Canadian market because of the risk of serious, potentially fatal adverse effects from the combination of the ingredients in the product.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_11-eng.php

Biologics, Radiopharmaceuticals & Genetic Therapies (BRGD)

Summary Basis of Decision: A Summary Basis of Decision (SBD) has been issued for Prolia.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/sbd_smd_2011_prolia_121139-eng.php

Therapeutic Products Directorate (TPD)

Notice: A Notice has been issued regarding Software Regulated as a Class I or Class II Medical Device.
http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/announce-annonce/md_notice_software_im_avis_logicels-eng.php

FAQs: Frequently Asked Questions are available for Software Regulated as a Medical Device.
http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/announce-annonce/md_qa_software_im_qr_logicels-eng.php

List of Registrars: The List of Registrars recognized by Health Canada under section 32.1 of the Medical Devices Regulations (MDR) has been updated.
http://www.hc-sc.gc.ca/dhp-mps/md-im/qualsys/list_liste_regist-eng.php

Notice of Decision: A Notice of Decision has been issued for Nucynta CR.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/nd_ad_2011_nucynta_cr_133167-eng.php

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

Guidance: The Guidance Document entitled, “Guidelines for Temperature Control of Drug Products during Storage and Transportation”, is available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/docs/gui-0069_ltr-eng.php

National Interest

Federal Government – Chemical Substances Challenge

Canadian Environmental Protection Act, 1999: The Minister of the Environment published in the Canada Gazette Part II, an Order amending the Domestic Substances List to apply the Significant New Activity provisions of the Canadian Environmental Protection Act, 1999 to one substance in Batch 10 of the Challenge.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-10/index-eng.php

Gazette II

Canadian Environmental Protection Act, 1999: Order 2010-87-12-01 has been issued amending the Domestic Substances List.
http://www.gazette.gc.ca/rp-pr/p2/2011/2011-02-02/html/sor-dors2-eng.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Educational Tools: British Columbia has provided general practitioners in the province with educational tools to help improve the prescribing of proton pump inhibitors (PPIs) and the practice of self-monitoring of blood glucose (SMBG). Key messages from CADTH’s recommendations on PPIs and SMBG are included in these user-friendly products.
http://www.cadth.ca/index.php/en/media-centre/2011/02/1/240

Reports: The following reports are available.

http://www.cadth.ca/media/pdf/htis/jan-2011/L0233_Antiviral_Stockpiling_Pandemic.pdf
(Antiviral Stockpiling Strategies for Pandemic Influenza: A Review of the Clinical and Cost-Effectiveness)

http://www.cadth.ca/media/pdf//htis/jan-2011/K0298_Insulin_pumps_adults.pdf
(Insulin Pumps for Type 1 and Type 2 Diabetes in Adults: Clinical and Cost-Effectiveness Analyses)

http://www.cadth.ca/media/pdf//htis/jan-2011/K0297_Infusion_Pumps.pdf
(Infusion Pump Pressure: Clinical Evidence and Guidelines)

http://www.cadth.ca/media/pdf//htis/jan-2011/J0501_LEAN_Process_Cath_Lab_Scheduling.pdf
(Economic Impact of Implementing a LEAN Process for Scheduling Patients to Cardiac Catheterization Laboratories: Cost-Effectiveness and Guidelines)

http://www.cadth.ca/media/pdf/htis/jan-2011/K0304_PICC_lines_final.pdf
(Positive Pressure versus Negative Pressure Adapters on Peripherally Inserted Central Catheters: Clinical Effectiveness and Safety)

http://www.cadth.ca/media/pdf/htis/jan-2011/K0300_Combination_Therapy_PAH.pdf
(Combination Therapy for Pulmonary Arterial Hypertension: Clinical Effectiveness)

http://www.cadth.ca/media/pdf//htis/jan-2011/K0299_Insulin_pumps_pediatrics.pdf
(Insulin Pumps for Type 1 and Type 2 Diabetes in Pediatrics: Clinical and Cost-Effectiveness Analyses)

http://www.cadth.ca/media/pdf//htis/jan-2011/J0502_Transvenous_pacemakers.pdf
(Nursing Care of Patients Requiring Transvenous Pacemakers: Guidelines)

http://www.cadth.ca/media/pdf/htis/jan-2011/L0240_Insulin_Infusions_During_Labour.pdf
(Intravenous Insulin Infusions in Labouring Women: Guidelines)

http://www.cadth.ca/media/pdf//htis/jan-2011/J0500_Arthroscopy_Knee.pdf
(Arthroscopy For The Knee: Clinical and Cost-Effectiveness)

http://www.cadth.ca/media/pdf/htis/jan-2011/K0305_Aspiration_PICC_Devices.pdf
(Aspirating Peripherally Inserted Central Catheters: Patient Safety and Clinical Guidelines)

http://www.cadth.ca/media/pdf/htis/jan-2011/J0505_Blood_Sequence_Guidelines.pdf
(Priority and Sequence of Collection for Blood Specimens: Clinical Evidence and Guidelines)

http://www.cadth.ca/media/pdf/htis/jan-2011/L0246_Facet_Joint_Injections.pdf
(Facet Joint Injection as Diagnostic and Therapeutic Tools for Pain of the Cervical and Lumbar Spine: A Review of Clinical and Cost-Effectiveness)

http://www.cadth.ca/media/pdf/htis/jan-2011/K0311_CPAP_vs_bag_mask_valve.pdf
(Non-Invasive Continuous Positive Airway Pressure Masks for Adults with Chronic Obstructive Pulmonary Disease or Congestive Heart Failure: Clinical Effectiveness)

http://www.cadth.ca/media/pdf/htis/jan-2011/K0309_TRUS_Biopsy.pdf
(Transrectal Ultrasound Biopsy for Patients with Suspected Prostate Cancer: Guidelines and Optimal Practice)

http://www.cadth.ca/media/pdf/htis/jan-2011/K0308_BoneBlood_Marrow_Transplants.pdf
(Blood and Bone Marrow Transplants in Adult Patients with Primary Leukemia: Clinical Effectiveness, Cost-Effectiveness, and Safety)

http://www.cadth.ca/media/pdf/htis/jan-2011/K0321_CO_Treatment_and_Measurement_final.pdf
(Carbon Monoxide Exposure Measurement and Treatment: Clinical Evidence and Guidelines)

http://www.cadth.ca/media/pdf/htis/jan-2011/K0316_Bacteria_Transmission_through_Jewelry_final.pdf
(Jewellery and the Risk of Bacteria Transmission from Healthcare Workers to Patients: Clinical Evidence)

http://www.cadth.ca/media/pdf/htis/jan-2011/K0303_Thoracentesis_Guidelines_final.pdf
(Thoracentesis for Adult Patients: Guidelines)

http://www.cadth.ca/media/pdf//htis/jan-2011/J0503_Potassium_Chloride_Stability.pdf
(Stability of Concentrated Potassium Chloride in Polyvinyl Chloride Containers: Clinical Evidence)

http://www.cadth.ca/media/pdf/htis/jan-2011/L2039_Fentanyl_draft_final.pdf
(Use of Fentanyl and Continuous Electronic Fetal Monitoring in Labour and Delivery: A Review of Clinical Effectiveness, Safety, and Clinical Practice Guidelines)

Patented Medicine Prices Review Board (PMPRB)

Newsletter: The PMPRB has released its January 2011 NEWSletter.
http://www.pmprb-cepmb.gc.ca/english/View.asp?x=1426&mp=287

Health Council of Canada (HCC)

Report: The Report entitled, “A Citizen's Guide to Health Indicators”, is available.
http://healthcouncilcanada.ca/en/index.php?page=shop.product_details&flypage=shop.flypage&product_id=135&category_

 

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HEADS UP - January 17, 2011

Notices of Compliance - January 10 - 14, 2011

• Byetta (1.2ML Prefilled Pen. 60 Doses of 5µG/Dose), Byetta (2.4ML Prefilled Pen. 60 Doses OF 10µG/Dose) [exenatide] was approved as an antihyperglycemic agent on 2011-01-13.

• Revolade (eltrombopag olamine) was approved as a thrombopoietin receptor agonist on 2011-01-12.

• Rapaflo (silodosin) was approved as a selective antagonist for alpha1A adrenoreceptor subtype in the prostate and bladder on 2011-01-11.

On the Move

• The National Association of Pharmacy Regulatory Authorities welcomed a new member, the Nunavut Department of Health and Social Services.
http://napra.ca/Content_Files/Files/NR_NAPRA_Welcomes_Nunavut_January252011_English_Final.doc.pdf

News from Health Canada

Health Canada

Health Advisory: Health Canada has released the health advisory entitled, “It's Your Health - Disposal and Use of Medication”.
http://www.hc-sc.gc.ca/hl-vs/iyh-vsv/med/disposal-defaire-eng.php

 Health Advisory: Health Canada has released the health advisory entitled, “It's Your Health - Injectable Cosmetic Treatments”.
http://www.hc-sc.gc.ca/hl-vs/iyh-vsv/med/injectable-cosmet-eng.php

Health Advisory: Health Canada has released the health advisory entitled, “It's Your Health - Safe Use of Medicines”.
http://www.hc-sc.gc.ca/hl-vs/iyh-vsv/med/safe-secure-eng.php

Natural Health Products Directorate (NHPD)

ePLA: An updated version of the electronic Product Licence Application form (ePLA) – version 1.4.2 – has been released and is available for use on the Natural Health Products Directorate (NHPD) website.  In concert with the release of ePLA 1.4.2, the Natural Health Product Ingredient Database (NHPID) has been updated with several feature enhancements as well.  Also, the NHPD is releasing a new online feature; the Electronic Submission Builder (eSB).   Please review the attached document for details of the NHP Online Solution enhancements.
(www.jptcp.com/files/ePLA_BEEP_2011_01_27_EN_Final.pdf)

http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/online-enligne/pla-dlmm-view-eng.php
(Electronic Product Licence Application Form (ePLA) -version 1.4.2)

http://webprod.hc-sc.gc.ca/nhpid-bdipsn/search-rechercheReq.do
(Updated Natural Health Product Ingredient Database)

Data Extract Update: The Licensed Natural Health Product Database (LNHPD) Data Extract has been updated as of January 20, 2011.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/lnhpd-bdpsnh_data_extract-eng.php

Therapeutic Products Directorate (TPD)

Guidance: Health Canada is pleased to announce the release of the Guidance for the Interpretation of Significant Changes of a Medical Device.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/signchng_modimportante-eng.php

Meeting: A Record of Decision is available for the October 6, 2010 meeting between Health Canada and the Canadian Pharmacists Association.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/assoc/2010-10-06-eng.php

Summary Report: A Summary Report entitled, “Stakeholder Consultations on the Good Manufacturing Practices (GMP) Inspection Program Review”, is available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/docs/gmp-bpf_rpt-eng.php

National Interest

Federal Government – Chemical Substances Challenge

Canadian Environmental Protection Act, 1999: The Minister of the Environment and the Minister of Health published in the Canada Gazette, Part I, a Notice of Intent to amend the Domestic Substances List to apply the Significant New Activity provisions of the Canadian Environmental Protection Act, 1999 to five substances in Batch 2 of the Challenge.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-2/index-eng.php

Gazette I

Canadian Environmental Protection Act, 1999: A Notice of Intent has been issued to amend the Domestic Substances List under subsection 87(3) of the Canadian Environmental Protection Act, 1999 to indicate that subsection 81(3) of that Act applies to five substances in Batch 2 of the Chemical Substances Challenge.
http://www.gazette.gc.ca/rp-pr/p1/2011/2011-01-22/html/index-eng.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Reports: The following reports are available.

http://www.cadth.ca/index.php/en/hta/reports-publications/environmental-scans/environmental-scans-issue-11
(Issue 11: The Global Impact of Technetium-99m Shortages)

http://www.cadth.ca/index.php/en/hta/reports-publications/environmental-scans/environmental-scans-issue-10
(Issue 10: Future Alternatives to Molybdenum-99 Production for Medical Imaging, 2010)

http://www.cadth.ca/index.php/en/hta/reports-publications/search/publication/2775
(Vancomycin or Metronidazole for Treatment of Clostridium difficile Infection: Clinical and Economic Analyses)

Medical Isotopes & Alternatives: The Canadian Agency for Drugs and Technologies in Health has been selected by the Government of Canada to conduct a research project on the optimal use of medical isotopes and alternatives.
http://www.cadth.ca/index.php/en/media-centre/2011/01/25/238

Patented Medicine Prices Review Board (PMPRB)

Celgene: The Supreme Court of Canada released its decision in the matter of Celgene and the drug product, Thalomid.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=197
 

 

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HEADS UP - January 10, 2011

Notices of Compliance - January 3 - 7, 2011

• There were no new NOCs published this week.

News from Health Canada

Health Canada

Health Advisory: The Honourable Leona Aglukkaq, Minister of Health, and Pierre Poilievre, Member of Parliament for Nepean-Carleton, announced new regulations that will restrict the use of six phthalates in toys and child care articles in order to limit exposure to children and infants.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2011/2011_07-eng.php

Health Advisory: Health Canada is informing Canadians that Bowers Medical Ltd. has initiated a voluntary recall of alcohol swabsticks, swabs and prep pads manufactured by the Triad Group.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_06-eng.php

Health Advisory: Health Canada is updating Canadians on steps it is taking to determine if any new action may be needed to protect health and safety in addition to the recent updating of its acetaminophen labelling standard.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_05-eng.php

Biologics, Radiopharmaceuticals & Genetic Therapies Directorate (BRGD)

Summary Basis of Decision: A Summary Basis of Decision (SBD) is available for Berinert.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/sbd_smd_2011_berinert_121221-eng.php

Summary Basis of Decision: A Summary Basis of Decision (SBD) is available for Flumist.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/sbd_smd_2011_flumist_129379-eng.php

Notice of Compliance with conditions: A Notice of Compliance with conditions (NOC/c) has been issued for Avastin (bevacizumab) Hoffman-La Roche Ltd.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/avastin_nocc_130719-eng.php

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/avastin_fs_fd_130719-eng.php
(Fact Sheet for Avastin)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/avastin_dhcpl_lapds_130719-eng.php
(Dear Health Care Professional Letter for Avastin)

Therapeutic Products Directorate (TPD)

Guidance: Health Canada has finalized the guidance document entitled, "Mandatory Problem Reporting for Medical Devices (GUI-0059)".
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/prob-report-rapport/gui-0059_mand-oblig_let-eng.php

http://www.hc-sc.gc.ca/dhp-mps/compli-conform/prob-report-rapport/gui-0059_mand-oblig_doc-eng.php
(Guidance: Mandatory Problem Reporting for Medical Devices (GUI-0059))

http://www.hc-sc.gc.ca/dhp-mps/compli-conform/prob-report-rapport/frm-0237_prel-report-eng.php
(Preliminary Report Form (FRM-0237))

http://www.hc-sc.gc.ca/dhp-mps/compli-conform/prob-report-rapport/frm-0238_final-report-eng.php
(Final Report Form (FRM-0238))

http://www.hc-sc.gc.ca/dhp-mps/compli-conform/prob-report-rapport/frm-0255_prel-final-report-eng.php
(Preliminary and Final Report Form (FRM-0255))

Guidance: Health Canada has finalized the guidance document entitled, "Voluntary Problem Reporting for Medical Devices (GUI-0060)".
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/prob-report-rapport/gui-0060_prob-rpt_let-eng.php

http://www.hc-sc.gc.ca/dhp-mps/compli-conform/prob-report-rapport/gui-0060_prob-rpt_doc-eng.php
(Guidance: Voluntary Problem Reporting for Medical Devices (GUI-0060))

http://www.hc-sc.gc.ca/dhp-mps/compli-conform/prob-report-rapport/frm-0029_prob-rpt-eng.php
(User Problem Report Form (FRM-0029))

National Interest

Federal Government – Chemical Substances Challenge

Chemical Substances Challenge: On January 15, 2011, seven Notices relating to the final assessment decisions for 13 substances in Batch 10 of the Challenge were published in the Canada Gazette Part I, and the final screening assessments were released.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-10/index-eng.php

Summary Report: The Summary Report for the August 2010 meeting of the Challenge Advisory Panel and the Government response to recommendations from the Challenge Advisory Panel pertaining to Batch 11 substances are now available.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/panel-groupe/meet-reunion-eng.php

Gazette I

Canadian Environmental Protection Act, 1999: The Final Decision is available after Screening Assessment of Substances in Batch 10 of the Chemical Substances Challenge.
http://www.gazette.gc.ca/rp-pr/p1/2011/2011-01-15/html/sup2-eng.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Reports: The following reports are available.

http://www.cadth.ca/media/pdf//htis/jan-2011/K0294_Monitoring_vital_signs.pdf
(Monitoring of Vital Signs in Adult Patients)

http://www.cadth.ca/media/pdf//htis/jan-2011/J0496_Waterless_Scrubless_OR.pdf
(Waterless, Scrubless Operating Room Skin Preparations for Health Professional Use: Clinical Effectiveness and Guidelines)

http://www.cadth.ca/media/pdf//htis/jan-2011/J0499_Osmotic_Laxatives.pdf
(Osmotic Laxatives for the Treatment of Constipation in Children with Cystic Fibrosis: Clinical Effectiveness, Safety, and Guidelines)

http://www.cadth.ca/media/pdf//htis/jan-2011/K0306_HeartWare_Heart_Failure.pdf
(HeartWare Ventrical Assist System for End Stage Heart Failure: Clinical Effectiveness, Safety, and Guidelines)

http://www.cadth.ca/media/pdf//htis/jan-2011/J0494_Distance_X-Ray_Ultrasound.pdf
(X-Ray and Ultrasound Imaging via Telehealth: Clinical Effectiveness, Cost-Effectiveness and Guidelines)

http://www.cadth.ca/media/pdf//htis/jan-2011/K0301_Vitalux_AMD.pdf
(Vitalux for Age-related Macular Degeneration: Clinical Effectiveness)

Health Council of Canada

Webinar: The Community for Excellence in Health Governance cordially invites you to a webinar to mark the launch of ‘A Citizen’s Guide to Health Indicators’.
http://pilot.myhealthboard.ca/health-indicators/
 

 

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HEADS UP - January 3, 2011

Notices of Compliance - December 27 - 31, 2010

• There were no new NOCs published this week.

News from Health Canada

Health Canada

Health Advisory: Following our communication regarding the Shandex Sales Group's voluntary recall of alcohol swabs manufactured by Triad from the Canadian market, Health Canada is informing Canadians that the drug, COPAXONE®, used in the treatment of Multiple Sclerosis, has been co-packaged in a kit produced by Teva with recalled alcohol prep pads manufactured by Triad.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_04-eng.php

Health Advisory: Health Canada is informing Canadians that the Shandex Sales Group has initiated a voluntary recall of alcohol swabs from the Canadian market.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_02-eng.php

Health Advisory: The product Synerate, manufactured for Strive and distributed by Upper 49th, is being voluntarily recalled from the Canadian market because of the risk of serious, potentially fatal adverse effects from the combination of the ingredients in the product.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_01-eng.php

Chemicals Management Plan: On January 8, 2011, the Honourable Peter Kent, Minister of the Environment, and the Honourable Leona Aglukkaq, Minister of Health, released draft screening assessment reports for Batch 12 of the Chemicals Management Plan's Challenge Initiative.
http://www.ec.gc.ca/default.asp?lang=En&n=714D9AAE-1&news=49AC51A6-4FE3-4734-B95E-97EC145F8C2C

Biologics, Radiopharmaceuticals & Genetic Therapies (BRGD)

Meeting: A Record of Meeting is available for the July 27, 2009 meeting of the Expert Advisory Committee on Blood Regulation.
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/activit/com/eacbr-ccers/_meet-reunion/mm-crr_2009-07-27-eng.php

Therapeutic Products Directorate (TPD)

Consultation: Health Canada is pleased to announce the release of the draft guidance document GD211: Guidance on the content of quality management system audit reports for a 60-day comment period.
http://www.hc-sc.gc.ca/dhp-mps/consultation/md-im/consult_draft_ebauche_md_im_gd211-eng.php

http://www.hc-sc.gc.ca/dhp-mps/consultation/md-im/draft_ebauche_md_im_gd211-eng.php
(Draft Guidance Document GD211: Guidance on the content of quality management system audit reports)

Newsletter: The Canadian Adverse Reaction Newsletter, Volume 21 - Issue 1 - January 2011 is available.
http://www.hc-sc.gc.ca/dhp-mps/medeff/bulletin/carn-bcei_v21n1-eng.php

Call for Nominations: A Call for Nominations has been issued for the Expert Advisory Committee on the Vigilance of Health Products (EAC-VHP).
http://www.hc-sc.gc.ca/dhp-mps/medeff/eacvhp-ccvrps/nomin-candid-eng.php

Meeting: A Record of Proceedings is available for the June 1, 2010 meeting between Health Canada and the Scientific Advisory Committee on Medical Devices used in Cardiovascular Systems.
http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/sci-com/cardio/sacmducs_rop_ccsmmuac_crd_2010-06-01-eng.php

http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/sci-com/cardio/sacmducs_a_ccsmmuac_o_2010-06-01-eng.php
(Agenda - June 1, 2010, Scientific Advisory Committee on Medical Devices used in Cardiovascular Systems)

Meeting: A Record of Decisions is available for the September 29, 2010 meeting between Health Canada and Consumer Health Products Canada (CHP Canada).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/assoc/2010-09-29-eng.php

Summary Basis of Decision: A Summary Basis of Decision (SBD) is available for Firmagon.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/sbd_smd_2010_firmagon_120421-eng.php

Summary Basis of Decision: A Summary Basis of Decision (SBD) is available for Uloric.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/sbd_smd_2010_uloric_129969-eng.php

National Interest

Federal Government

Chemicals Management Plan: The Minister of the Environment and the Minister of Health published 9 Notices in the Canada Gazette, Part I, concerning the draft screening assessment reports for 12 of the 16 substances in Batch 12 of the Challenge.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-12/index-eng.php

Gazette I

Canadian Environmental Protection Act, 1999: Publication after screening assessment of substances in Batch 12 of the Chemicals Management Plan is available.
http://www.gazette.gc.ca/rp-pr/p1/2011/2011-01-08/html/sup-eng.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Reports: The following reports are available.

http://www.cadth.ca/media/pdf//htis/dec_2010/L0231_Fluoride_Rinse_Programs_final.pdf
(Fluoride Rinse Programs for School Aged Children: A Review of the Clinical Effectiveness and Guidelines)

http://www.cadth.ca/media/pdf/htis/dec_2010/J0497_Pain_Assessment_Tools_final.pdf
(Pain Assessment Tools for Elderly Patients: Reliability, Validity, and Guidelines for Use)

http://www.cadth.ca/media/pdf/M0022_Benzodiazepines_in_the_Elderly_L3_e.pdf
(Benzodiazepines in Older Adults: A Review of Clinical Effectiveness, Cost-Effectiveness, and Guidelines)

Pharmaceutical Advertising Advisory Board (PAAB)

Newsletter: The January 2011 issue of the PAAB Review is available.
http://www.paab.ca/local/files/PAAB%20Review%20Newsletter%20January%202011%20E%20%282%29.pdf

National Association of Pharmacy Regulatory Authorities (NAPRA)

NDSAC Meeting: The next meeting of the National Drug Scheduling Advisory Committee (NDSAC) is scheduled for March 6, 2011. The main purpose of the meeting is to consider the following matter:

-A reassessment of the request for a change in scheduling of Naproxen sodium 220 mg per tablet (when sold in products labeled with a recommended maximum daily dose of 440 mg, and in package sizes exceeding 6,600 mg) to Unscheduled

http://napra.ca/pages/home/default.aspx?id=2866
 

 

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HEADS UP - December 27, 2010

Notices of Compliance - December 20 - 24, 2010

• There were no new NOCs published this week.

On the Move

• The Canadian Agency for Drugs and Technologies in Health (CADTH) introduces its new Board of Directors.
http://www.cadth.ca/index.php/en/cadth/corporate-profile/board-of-directors-2

News from Health Canada

Therapeutic Products Directorate (TPD)

Application: An Application is available for a New Medical Device Licence for a Private Label Medical Device.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/licapp_demhom_label_marque_npriv-eng.php

Application: An Application is available for a Medical Device Licence Amendment for a Private Label Medical Device.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/licamm_demmhom_label_marque_priv-eng.php

New Application Form: A new Class IV Medical Device Licence Application Form is available.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/licapp_demhom_cla4-eng.php

Application Form: A Class IV Medical Device Licence Amendment Application Form is available.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/md_licam_im_demmhom_cla4-eng.php

New Application Form: A new Class III Medical Device Licence Application Form is available.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/licapp_demhom_cla3-eng.php

Application Form: A Class III Medical Device Licence Amendment Application Form is available.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/md_licam_im_demmhom_cla3-eng.php

New Application Form: A new Class II Medical Device Licence Application Form is available.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/licapp_demhom_cla2-eng.php

Application Form: A Class II Medical Device Licence Amendment Application Form is available.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/md_licam_im_demmhom_cla2-eng.php

Update: The Quarterly Update to the Canada Vigilance Online Adverse Reaction Database has taken place.
http://www.hc-sc.gc.ca/dhp-mps/medeff/databasdon/index-eng.php

Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

Reports: The following reports are available.

http://www.cadth.ca/media/pdf/htis/dec_2010/K0293_Needle_Aspiration.pdf
(Needle Aspiration Prior to Immunization: Clinical Evidence and Guidelines)

http://www.cadth.ca/media/pdf/htis/dec_2010/L0237_Array_Comparative_Genomic_Hybridization.pdf
(Array Comparative Genomic Hybridization: A Review of Cost Effectiveness and Clinical Practice Guidelines)

http://www.cadth.ca/media/pdf/htis/dec_2010/J0492_Insulin_Infusions_During_Labour.pdf
(Intravenous Insulin Infusions in Labouring Women: Guidelines)

http://www.cadth.ca/media/pdf/htis/dec_2010/J0495_Dashboard_communication.pdf
(Dashboards for Communication in Healthcare Settings: Clinical Evidence and Guidelines)

http://www.cadth.ca/media/pdf/htis/dec_2010/L0234_Clozapine_Treatment_Hospitalized_Patients.pdf
(Clozapine Treatment of Hospitalized Patients: A Review of Clinical Practice Guidelines and Safety)

http://www.cadth.ca/media/pdf/htis/dec_2010/L0236_Antivirals_Pandemic_Influenza.pdf
(Antivirals for Pandemic Influenza: A Review of the Clinical Effectiveness)

Canadian Institutes of Health Research (CIHR)

Newsletter: The January 2011 issue of the CIHR Media Newsletter is available.
http://www.cihr-irsc.gc.ca/e/42859.html
 

 

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Regulatory Notes Archive