Regulatory Notes

HEADS UP - September 2, 2013


Notices of Compliance - August 26 – August 30, 2013

•    There were no new NOCs published this week.

News from Health Canada…

Health Canada

Announcement:
The Honourable Rona Ambrose, Minister of Health, today addressed the 2013 North America Consumer Product Safety Summit in Ottawa. The Minister highlighted the important role international cooperation plays in protecting the health and safety of Canadians and reaffirmed the Government of Canada's commitment to consumer product safety.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2013/2013-123-eng.php

Information Update: Health Canada wishes to inform Canadians that Vita Health Products Inc. has voluntarily recalled a variety of health products from the Canadian market because of labeling issues. The recalled products pose a risk to health because the labels contain errors such as suggesting packages are child resistant when they are not, or are missing warning statements for consumers with allergies or existing medical conditions.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/35525a-eng.php

Biologics and Genetic Therapies Directorate (BGTD)

Policy Statement:
A Policy Statement describing BGTD's approach to regulating low molecular weight heparins (LMWHs) containing medicinal products claiming to be similar to another heparin which is already marketed is available.
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/applic-demande/guides/lmwh-pol-hfmm-eng.php

Natural Health Products Directorate (NHPD)

Document:
The Natural Health Products Directorate (NHPD) has provided a list of dosage forms it recognizes as being commonly found in cosmetic products.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/online-enligne/nhpid-bipsn-cos-eng.php

Therapeutic Products Directorate (TPD)

    Health Professional Advisory

Sutent:
Pfizer Canada Inc. (manufacturer of Sutent), in collaboration with Health Canada, would like to inform you about an important revision to the Product Monograph, including the consumer information section, for Sutent (sunitinib malate). A statement has been recently added to the Product Monograph to inform Health Care Professionals and patients about a potential association between the use of Sutent and severe cutaneous reactions suggestive of Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN).
    http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/35473a-eng.php

Doudopa: AbbVie Corporation is pleased to announce that Health Canada has issued a marketing authorization with conditions under the Notice of Compliance with Conditions (NOC/c) policy to DUODOPA (levodopa/carbidopa intestinal gel), for use in the treatment of advanced levodopa-responsive Parkinson's disease when satisfactory control of severe, disabling motor fluctuations and hyper-/dyskinesia cannot be achieved with available combinations of Parkinson medicinal products.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/duodopa_dhcpl_lapds_158346-eng.php

    Consumer Health Advisory

Sutent: Pfizer Canada Inc. (manufacturer of Sutent), in collaboration with Health Canada, would like to inform you about an important revision to the Product Monograph, including the consumer information section, for Sutent (sunitinib malate). Sutent is a medication that is used to treat cancer of the stomach and bowels, kidney, and pancreas. A statement has been added in the product monograph to inform Health Care Professionals and patients about a potential association between Sutent and severe and sometimes life-threatening skin rashes such as Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN).
    http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/35475a-eng.php

Post-Authorization Activity Table: A Post-Authorization Activity Table for Perjeta is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2013_perjeta_158419-eng.php#paat

Post-Authorization Activity Table: A Post-Authorization Activity Table for Neupro is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2013_neupro_145523-eng.php#paa

Post-Authorization Activity Table: A Post-Authorization Activity Table for Fycompa is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2013_fycompa_153747-eng.php

Fact Sheet: A Duodopa Product Specific Fact Sheet is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/duodopa_fs_fd_158346-eng.php

Product Monograph Brand Safety Updates: The Product Monograph Brand Safety Updates are available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/databasdon/pm_saf_mp_innoc/lab_safety_rep_rap_eval_etiq-eng.php
 

HEADS UP - July 22, 2013


Notices of Compliance - July 15 – July 19, 2013

•    Mekinist (trametinib) was approved as a Protein Kinase Inhibitor on 2013-07-18.
•    Tafinlar (dabrafenib) was approved as a Protein Kinase Inhibitor on 2013-07-16.

News from Health Canada…

Health Canada

Health Advisory:
Vita Health Products Inc., in consultation with Health Canada, is voluntarily recalling three lots of its Compliments Iron Ferrous Gluconate tablets (Product number: NPN 00582727; package of 100, 324 mg tablets) sold across Canada due to a labelling error.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/34785a-eng.php

Information Update: A safety review conducted by Health Canada has concluded that there is a slightly increased risk of cancer associated with the prolonged use of calcitonin products. A review of the benefits and risks of the nasal spray products found that there was not enough evidence of benefit to continue using calcitonin nasal sprays in treating osteoporosis, given the increased risk of cancer. As a result of these reviews, calcitonin nasal spray products will no longer be authorized for sale in Canada as of October 1, 2013.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/34843a-eng.php

Natural Health Products Directorate (NHPD)

Report: The NHPD Quarterly Snapshot for Quarter 1 of Fiscal Year 2013-2014 is available.
(See attached).www.jptcp.com/files/NHPD___Quarterly_Snapshot_13_14,_Q1_1.pdf    www.jptcp.com/files/DPSN___Aperçu_trimestriel_13_14,_1er_trimestre_1.pdf

Therapeutic Products Directorate (TPD)

    Health Care Professional Advisory


Rituxan: Hoffmann-La Roche Limited (Roche), in consultation with Health Canada, would like to inform you of important updates to the recommendations for screening and management of hepatitis B virus reactivation in patients treated with Rituxan. Use of Rituxan has been shown to be associated with recurrence of hepatitis B virus infection in patients who show evidence of the virus in a blood test. It is advised that all patients be tested for hepatitis B virus infection before starting treatment with Rituxan.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/34765a-eng.php

Calcimar: Sanofi-aventis Canada Inc. (Sanofi Canada), in collaboration with Health Canada, would like to inform you about important changes to the conditions of use for Calcimar regarding an increased risk of malignancies (cancer) with long term calcitonin use.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/34781a-eng.php

Miacalcin/Sandoz Calcitonin/Apo-Calcitonin: A safety review conducted by Health Canada has concluded that there is a slightly increased risk of cancer associated with the prolonged use of calcitonin products. The manufacturers of synthetic calcitonin (salmon) nasal spray (NS) products, in collaboration with Health Canada, would like to advise you of the market withdrawal of these Products, effective October 1st, 2013.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/34783a-eng.php

Consumer Health Advisory

Rituxan:
Hoffmann-La Roche Limited, in consultation with Health Canada, has informed health care professionals of important updates to safety information for Rituxan. In the existing prescribing information for Rituxan, hepatitis B virus screening is recommended for patients at high risk of hepatitis B infection before initiation of treatment with Rituxan.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/34771a-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

Post-Authorization Activity Table: A Post-Authorization Activity Table (PAAT) for Tecfidera is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2013_tecfidera_154776-eng.php

Post-Authorization Activity Table: A Post-Authorization Activity Table (PAAT) for Fycompa is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2013_fycompa_153747-eng.php#paat

National Interest

Canadian Intellectual Property Office (CIPO)

Agreements:
All of CIPO’s Patent Prosecution Highway agreements will now adopt the Mottainai guidelines.
http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr03677.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter:
The July edition of new of CADTH is now available.
http://www.cadth.ca/en/media-centre/new-at-cadth/new-at-cadth-july13

Newsletter: The newsletter, CDR Update – Issue 89, discusses changes to the CDR patient input process, an invitation for feedback on a proposal to post patient input submissions, and a pilot process for individual patients and caregivers to provide patient input.
http://www.cadth.ca/en/products/cdr/cdr-update/cdr-update-89?utm_source=cdr-update-89&utm_medium=webmail&utm_campaign=e-alert-07-26-13

Consultation: A draft recommendations report on drug therapies for the management of relapsing-remitting multiple sclerosis is now available for feedback from all interested stakeholders.
http://www.cadth.ca/en/media-centre/e-alert/e-alert-07-31-13

Patented Medicine Prices Review Board (PMPRB)

Voluntary Compliance Undertaking:
The Chairperson of the Board accepted a Voluntary Compliance Undertaking (VCU) for Elocom.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=331
 

HEADS UP - July 29, 2013


Notices of Compliance - July 22 – July 26, 2013

•    There were no new NOCs published this week.

News from Health Canada…

Health Canada

Announcement:
Today, Dr. Jake Thiessen's independent review for the Ontario government into quality assurance in Ontario's cancer drug supply chain was made public.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2013/2013-112-eng.php

Health Advisory: Health Canada is advising Canadians that Vita Health Products Inc. is voluntarily recalling all lots of Safeway Ibuprofen Liquid Capsules (200 mg capsules, 72 in a bottle) and Compliments Ibuprofen Liquid Capsules (200 mg, 72 capsules in a bottle). The recall is due to a labeling error that incorrectly states the products are packaged with a child-resistant cap.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/34867a-eng.php

Information Update: Health Canada is informing Canadians of a voluntary recall of certain lots of Nova Max Blood Glucose Test Strips (see list below) that were contaminated during the manufacturing process.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/34883a-eng.php

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

http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/34859a-eng.php
(Brazilian Slimming Coffee, Leisure 18 Slimming Coffee, 7 Days Slimming Coffee, Brazilian 7 Days Slimming Coffee, Beauty Secret Slimming Coffee, Body Beauty 5 Days Slimming Coffee, Leisure 18 Slimming Mango Juice, Leisure 18 Slimming Orange Juice, Authentic Leisure 18 Slimming Orange Juice, Super Slim Orange Juice, Coffee Fashion Slimming)

http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/34861a-eng.php
(Steelman Capsules 2)

http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/34861a-eng.php
(CO Feng Shi Gu Tong Ning Jiao Nang)

http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/34861a-eng.php
(Fu Fang Feng Shi Gu Kang Ling Jiao Nang)

http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/34869a-eng.php
(Best Slim capsules, Meizi Evolution Botanical Slimming soft gel capsules)

http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/34869a-eng.php
(Libigirl capsules)

http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/34863a-eng.php
(Albuterex Xtreme Formula)

http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/34863a-eng.php
(Albutarex Xtreme and Albutarex Femme Formula)

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 a possible under-fill of certain Sandoz products for injection distributed in vials. The quality and concentration of the products are not affected. However, the total available drug content in the under-filled vials would be lower than labelled.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/34873a-eng.php

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

Workshop proposals:
CADTH invites proposals for full or half-day workshops of significant interest to producers and users of evidence-based information and advice on health technologies. Workshops will be held on Sunday, April 6, 2014.
http://www.cadth.ca/en/events/cadth-2014-sympos/call-for-workshops

Patented Medicine Prices Review Board (PMPRB)

Newsletter:
The July 2013 edition of the PMPRB NEWSletter is available.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=332

National Association of Pharmacy Regulatory Authorities (NAPRA)

Newsletter:
The Summer 2013 edition of NAPRA Notes is now available.
http://napra.ca/Content_Files/Files/NAPRA_Notes_Summer_2013.pdf
 

HEADS UP - July 15, 2013


Notices of Compliance - July 8 – July 12, 2013

•    Erivedge (vismodegib) was approved as an antineoplastic agent on 2013-07-12.

News from Health Canada…

Health Canada

Health Advisory:
Three natural health products bearing the Natural Health Product Number NPN 80041194 and one unauthorized natural health product were tested by Health Canada and found to contain hidden ingredients (sildenafil analogs) that may pose serious risks to the health of Canadians.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/34719a-eng.php

Health Advisory: Three unauthorized health products (Progesta-Care Body Cream, DHEA 25 Age-Free and DHEA 50 Age-Free) that may pose serious risks to the health of Canadians were seized by Health Canada at Well Beings Health & Nutrition Centre located at Unit 202-22259 48th Ave, Langley, BC. The labels of these products indicate that they contain ingredients that require a prescription in Canada.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/34753a-eng.php

Recall: Extra Strength Cold & Flu-In-One has been recalled due to the lack of the caution statement: "CAUTION: KEEP OUT OF THE REACH OF CHILDREN. This package contains enough drug to seriously harm a child."
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/34733r-eng.php

Information Update: As the rate of obesity has increased in Canada, so has the market for weight-loss products. While authorized health products for weight loss may provide benefits when used properly as part of a weight management program, the use of unauthorized health products may pose serious risks to your health.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2012/15042a-eng.php

Therapeutic Products Directorate (TPD)

    Notice to Hospitals

Voluven and Volulyte:
This advisory informs of new contraindications and warnings for the use of hydroxyethyl starch in those with sepsis, renal impairment or severe liver disease. In patients requiring intensive or emergent care, the use of crystalloids in preference to HES solutions should be considered.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/34697a-eng.php

Fact Sheets: Fact Sheets on prohibitions related to assisted human reproductions are available.
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/legislation/reprod/index-eng.php

Post-Authorization Activity Table: A Post-Authorization Activity Table for Adcetris is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2013_adcetris_154851-eng.php#paat

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 Perjeta.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2013_perjeta_158419-eng.php

National Interest

Canadian Intellectual Property Office (CIPO)

Announcement:
CIPO, in conjunction with representatives of the IP community, is launching three projects to examine options for improving how they do business together. Their objective is to modernize their approaches to provide the best service possible to customers.
http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr03675.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Feedback:
At the end of July, draft recommendations from the therapeutic review on the management of relapsing-remitting multiple sclerosis will be posted on the CADTH website for stakeholder feedback.
http://www.cadth.ca/en/media-centre/e-alert/e-alert-07-22-13

 

HEADS UP - July 1, 2013


Notices of Compliance - June 24 – June 28, 2013

• Fibristal (ulipristal acetate) was approved as a selective progesterone receptor modulator on 2013-06-25.

News from Health Canada…

Health Canada

Announcement: Today, the Honourable Leona Aglukkaq, Minister of Health, announced that Health Canada is launching a consultation that begins the process of applying the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) for workplace chemicals in Canada.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2013/2013-91-eng.php

Health Advisory: An unauthorized product used as a topical skin antiseptic is being sold by Veslon Cosmetics and Super Discount Distributing. The product, Veslon Aqueous Chlorhexidine Gluconate Solution 2% w/v with 4% v/v isopropyl alcohol, is unlicensed and has an invalid Drug Identification Number on its label.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/34487a-eng.php

Information Update: Health Canada is reminding Canadians about the serious health risks associated with the use of “designer drugs”. Also referred to as “new psychoactive substances”, “ legal highs”, “herbal highs”, or “research chemicals”  - or by names such as “spice” and “bath salts” - the term “designer drugs” refers to a wide array of substances that are used recreationally for their psychoactive effects.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/34455a-eng.php

Natural Health Products Directorate (NHPD)

Product Monographs: The Natural Health Products Directorate (NHPD) is announcing the final posting of the Traditional Chinese Medicine Ingredients monograph which has been revised based on stakeholder feedback following a 30 day consultation period from September 25 to October 24, 2012.
www.jptcp.com/files/NHPD_Final_posting_of_monographs_1.pdf

Therapeutic Products Directorate (TPD)

 Health Care Professional Advisory

Aclasta: Novartis Pharmaceuticals Canada Inc., in collaboration with Health Canada, would like to provide you with information on a reported volume overfill for Aclasta vials (zoledronic acid 5 mg/100 mL) involving a single lot (lot number: 16FG0209). Please note however that there is no product recall for this lot.
 http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/34489a-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

Product Monograph Brand Safety Updates: The Product Monograph Brand Safety Updates are available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/databasdon/pm_saf_mp_innoc/lab_safety_rep_rap_eval_etiq-eng.php

Update: The Label Safety Assessment Update - Sponsor Attestation is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/databasdon/pm_saf_mp_innoc/lab_safety_att_eval_etiq-eng.php

Summary Basis of Decision: A Summary Basis of Decision is available for Neupro.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2013_neupro_145523-eng.php

Newsletter: The Canadian Adverse Reaction Newsletter, Volume 23 - Issue 3 - July 2013 is now available.
http://www.hc-sc.gc.ca/dhp-mps/medeff/bulletin/carn-bcei_v23n3-eng.php

Post-Authorization Activity Table: A Post-Authorization Activity Table for Myrbetriq.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2013_myrbetriq_153806-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

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

Consultation: The list of included studies for CADTH’s Optimal Use project on point-of-care testing of the international normalized ratio (INR) for patients taking warfarin or other vitamin K antagonists is available for input from all interested stakeholders.
http://www.cadth.ca/en/feedback?utm_source=inr-feedback-report&utm_medium=webmail&utm_campaign=e-alert-07-04-13

Patented Medicine Prices Review Board (PMPRB)

Notice of Hearing: The Board has issued a Notice of Hearing in the redetermination of the Teva Canada Innovation G.P.-S.E.N.C. and the medicine Copaxone matter.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=330
 

~~~~~

HEADS UP - June 24, 2013


Notices of Compliance - June 17 – June 21, 2013

• There were no new NOCs published this week.

News from Health Canada…

Health Canada

Announcement: The Honourable Leona Aglukkaq, Minister of Health, today invited Canadians to express their views on the Summary Report of the Round Table Discussion on Payment of Plasma Donors in Canada and issues related to the safety of plasma donation.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2013/2013-87-eng.php

Information Update: Health Canada is updating the list of retail locations that were found to be selling “poppers”. Health Canada has notified these retailers that the sale of “poppers” is not permitted under the Food and Drugs Act and is verifying that these unauthorized products have been removed from the Canadian market.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/34343a-eng.php

Biologics and Genetic Therapies Directorate (BGTD)

Consultation: On April 10, 2013, Health Canada organized a full-day roundtable discussion with key stakeholders on the issue of paying Canadians to donate plasma that will be used in the production of pharmaceutical products. Health Canada is now seeking feedback on the summary report of the roundtable with stakeholders and/or the background document.
http://www.hc-sc.gc.ca/dhp-mps/consultation/biolog/plasma-consult-eng.php

Natural Health Products Directorate (NHPD)

Guidance Document: The “Evidence for Quality of Finished Natural Health Products” guidance document has been replaced by the Quality of Natural Health Products Guide. The proposed document was published for a 90-day consultation period from August 31, 2012 to November 30, 2012. All comments received during the consultation period were considered prior to finalizing the guidance document.
www.jptcp.com/files/Quality_of_NHPs_Guide.pdf  www.jptcp.com/files/Guide_de_reference_sur_la_qualite_des_PSN.pdf

Calendar: A calendar outlining planned activities for the Natural Health Products Directorate (NHPD) covering the period between July 1, 2013 and December 31, 2013 is now available. The Activities Calendar will be posted at a later date on the Health Canada website.
www.jptcp.com/files/calendar_of_activities_July_to_Dec_2013_FRE_final_1.pdf   

www.jptcp.com/files/Calendar_of_Activities_July_to_Decembre_2013_EN_final_1.pdf

Canadian Agency for Drugs and Technologies in Health (CADTH)

Report: The report “Antithrombotic Agents for the Prevention of Stroke and Systemic Embolism in Patients With Atrial Fibrillation” is available.
http://www.cadth.ca/en/products/cadth-overviews/overview-volume-3/3-2-02

Report: The report “Transcatheter Aortic Valve Replacement in Severe Aortic Stenosis: A Review of Comparative Durability and Clinical Effectiveness Beyond 12 Months” is available.
http://www.cadth.ca/en/products/cadth-overviews/overview-volume-3/3-2-01

Reports: Updated reports and recommendations on Second- and Third-Line Therapies for Type 2 Diabetes are now available.
http://www.cadth.ca/en/products/optimal-use/second-line-therapies/reports
 

HEADS UP - June 17, 2013


Notices of Compliance - June 10 – June 14, 2013

• Striverdi Respimat (olodaterol hydrochloride) was approved as a long acting beta2 agonist on 2013-06-11.

News from Health Canada…

Health Canada

Announcement: Today, the Harper Government announced the first-ever mandatory recall in Canada for a consumer product. NeoMagnetic Gadgets Inc. was ordered to issue a recall and stop sale after the company failed to take voluntary action to remove their novelty magnet sets from the marketplace.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2013/2013-84-eng.php

Health Advisory: In consultation with Health Canada, Pendopharm, a division of Pharmascience Inc., is voluntarily recalling two lots of the ACET-650 acetaminophen suppository (DIN 02230437) due to dosage mislabeling on the blister packs inside the box. In the affected lots, some of the suppositories containing 650 mg may be labelled as 325 mg on the blister packs. The external box indicates the correct dose, 650 mg.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/34279a-eng.php

Information Update: Medtronic Canada Ltd., in consultation with Health Canada, is providing updated safety information regarding Paradigm and Polyfin Insulin Infusion Sets manufactured by Unomedical A/S and Medtronic Minimed due to a potential problem that could result in incorrect delivery of insulin to the patient.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/34261a-eng.php

Information Update: Health Canada and the manufacturers of blood volume expanders containing hydroxyethyl starch (HES) solutions recommend that these products no longer be used in critically ill patients with certain health conditions.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/34299a-eng.php

Biologics and Genetic Therapies Directorate (BGTD)

Report: The Biologics and Genetic Therapies Directorate Drug Submission Performance Annual Report; 2012-2013 is available.
www.jptcp.com/files/bgtd_dpbtg_annual_annuel_12_eng.pdf  www.jptcp.com/files/bgtd_dpbtg_annual_annuel_12_fra.pdf

Report: The Biologics and Genetic Therapies Directorate Drug Submission Performance Quarterly Report; January-March 2013 is available .www.jptcp.com/files/bgtd_dpbtg_13_jan_mar_eng.pdf

Therapeutic Products Directorate (TPD)

 Health Care Professional Advisory

Apo-Cephalex: Due to an inadvertent exposure to rain water, some lots of Apo-Cephalex 250 MG and Apo-Cephalex 500 MG may have decreased active drug content that could lead to reduced drug efficacy. Pharmacists should stop dispensing any of this affected product and replace recent dispensed prescriptions with unaffected product.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/34291a-eng.php

 Notice to Hospitals

AmBisome: Astellas Canada in consultation with Health Canada is advising you that Astellas Canada has initiated a voluntary recall for two lots of AmBisome (liposome amphotericin B for injection); the lot numbers are 042269AA with expiry date 07/2015 and 0422C1AA with expiry date 11/2015. These lots may have been exposed to bacterial contaminant during the manufacturing process.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/34277a-eng.php

Report: The Therapeutic Products Directorate Drug Submission Performance Annual Report; 2012-2013 is available. www.jptcp.com/files/tpd_dpt_annual_annuel_12_fra.pdf

Report: The Therapeutic Products Directorate Drug Submission Performance Quarterly Report; January-March 2013 is available.
www.jptcp.com/files/tpd_dpt_13_jan_mar_fra.pdf
 
Guidance Document: Health Canada is pleased to announce the release of the finalized Guidance Document for Clinical Trial Sponsors: Clinical Trial Applications.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/clini/ctdcta_ctddec-eng.php

Guidance Document: Health Canada is pleased to announce the release of the final guidance document- Determining Prescription Status for Human and Veterinary Drugs.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_gd_ord_ld-eng.php

Document: The Prescription Drug List is now available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_list_fin_ord-eng.php

Document: Questions and Answers for the Prescription Drug List are now available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_qa_fin_ord-eng.php#a1

Form: The Health Canada 3011: Drug Submission Application Form for Human, Veterinary, Disinfectant Drugs and Clinical Trial Application/Attestation is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/form/hc3011_sc3011-eng.php

Notice: Health Canada has issued a Notice regarding the Release of Electronic Specifications for Clinical Trial Applications and Amendments filed in accordance with Guidance Document for Clinical Trial Sponsors: Clinical Trial Applications.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/clini/cta_dec_elec_spec_gd_ld-eng.php

Document: Information for Industry on the proposed regulatory amendments to submit mock-ups of labels is available.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/pll_mockups_maq_elc-eng.php

Document: Information for Canadians about the Plain Language Labelling Initiative is available.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/pll_info_cdns_elc-eng.php

Document: Information for Industry on the proposed regulatory amendment for a Fact Table.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/pll_fact_tab_rens_elc-eng.php

Consultation: Health Canada is conducting a consultation on the Plain Language Labelling Initiative which will lead to changes to labelling for drugs that are available with a prescription and drugs available without a prescription.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult_pll_elc-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

Post-Authorization Activity Table: A Post-Authorization Activity Table (PAAT) for Potiga is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2012_potiga_134659-eng.php

Post-Authorization Activity Table: A Post-Authorization Activity Table (PAAT) for Stivarga is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2013_stivarga_157970-eng.php

National Interest

Gazette I

Food and Drugs Act:  Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) are available.
http://www.gazette.gc.ca/rp-pr/p1/2013/2013-06-22/html/reg2-eng.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Report: Environmental Scans – Issue 41 - Endovascular Therapy for Elective and Ruptured Abdominal Aortic Aneurysm Procedures: A Description of Utilization Trends Across Canada is available.
http://www.cadth.ca/products/environmental-scanning/environmental-scans/environmental-scan-41
 

~~~~~

HEADS UP - June 8, 2013


Notices of Compliance - June 1 – June 5, 2013

• There were no new NOCs published this week.

News from Health Canada…

Health Canada

Announcement: The Honourable Leona Aglukkaq, Minister of Health, today announced the launch of the Plain Language Labelling Initiative, which aims to improve the safe use of drugs by making drug labels and safety information easier to read and understand.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2013/2013-82-eng.php

HPFB Inspectorate

List: A List of Canadian Establishments that Process and/or Import Semen for Assisted Conception is available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/info-prod/don/can_semen_est-eta_can_sperme-eng.php

Guidance Document: The 2nd Edition CTO Guidance Document and Notice of Release are now available.
www.jptcp.com/files/CTO_Phase_I_v2_Guidance_Notice_2013_06_18_FR_1.pdf

www.jptcp.com/files/CTO_Phase_I_v2_Guidance_Notice_2013_06_18_EN_1.pdf

www.jptcp.com/files/CTO_Phase_I_v2_Guidance_final_2013_04_14_EN_1_1.pdf

www.jptcp.com/files/CTO_Phase_I_v2_Guidance_final_2013_04_14_EN_1.pdf

Therapeutic Products Directorate (TPD)

Health Care Professional Advisory

Ketoconazole: The manufacturers of Ketoconazole, in collaboration with Health Canada, would like to inform you of revisions to the Product Monograph for Ketoconazole regarding the risk of potentially fatal liver toxicity.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/34173a-eng.php

Notice to Hospitals

Ketoconazole: Apotex Inc. and Teva Canada Limited, in collaboration with Health Canada, would like to inform you of additional safety information regarding the marketed medication Ketoconazole (Apo-Ketoconazole and Novo- Ketoconazole). Ketoconazole, a medication that treats fungal diseases has been associated with rare cases of liver damage, including cases of death.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/34177a-eng.php

Guidance Document: The Guidance Document - Fees for the Review of Drug Submissions and Applications has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/fees-frais/fee_frais_guide-eng.php

Guidance Document: The Guidance Document: Fees for the Right to Sell Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/fees-frais/right_sell_guid_droit_vendre-eng.php

Guidance Document: The Guidance Document: Fees for the Review of Medical Device Licence Applications has been updated.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/guidedoc_feesmd_docorient_fraisim-eng.php

Product Monograph Brand Safety Updates: The Product Monograph Brand Safety Updates are available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/databasdon/pm_saf_mp_innoc/lab_safety_rep_rap_eval_etiq-eng.php

Summary Basis of Decision: A Summary Basis of Decision is available for Fycompa.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2013_fycompra_153747-eng.php

National Interest

Gazette II

Food and Drugs Act: Regulations Amending Certain Regulations Concerning Prescription Drugs (Repeal of Schedule F to the Food and Drug Regulations) is available.
http://www.gazette.gc.ca/rp-pr/p2/2013/2013-06-19/html/sor-dors122-eng.php

Food and Drugs Act: Regulations Amending the Food and Drug Regulations (1688 — Arsenic Trioxide) are available.
http://www.gazette.gc.ca/rp-pr/p2/2013/2013-06-19/html/sor-dors113-eng.php

Food and Drugs Act: Marihuana Exemption (Food and Drugs Act) Regulations is available.
http://www.gazette.gc.ca/rp-pr/p2/2013/2013-06-19/html/sor-dors120-eng.php

Controlled Drugs and Substances Act: Marihuana for Medical Purposes Regulations is available.
http://www.gazette.gc.ca/rp-pr/p2/2013/2013-06-19/html/sor-dors119-eng.php

Financial Administration Act: Regulations Amending the Fees in Respect of Drugs and Medical Devices Regulations is available.
http://www.gazette.gc.ca/rp-pr/p2/2013/2013-06-19/html/sor-dors121-eng.php

Canadian Intellectual Property Office (CIPO)

Strategy: The annual update of the CIPO Business Strategy 2012-2017 is now available.
http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr03667.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Feedback: In the coming weeks, a list of included studies for CADTH’s Optimal Use project on point-of-care testing of the international normalized ratio (INR) for patients taking warfarin or other vitamin K antagonists will be posted on the CADTH website for stakeholder feedback.
http://www.cadth.ca/en/media-centre/e-alert/e-alert-06-17-13

Newsletter: The June edition of New at CADTH is now available.
http://www.cadth.ca/en/media-centre/new-at-cadth/new-at-cadth-june-13

Report: The report: Ferumoxytol versus Other Intravenous Iron Therapies for Anemia: A Review of the Clinical and Cost-effectiveness and Guidelines is now available.
http://www.cadth.ca/en/publication/3784
 

~~~~~

HEADS UP - June 3, 2013


Notices of Compliance - May 27 – May 31, 2013

• Xtandi (enzalutamide) was approved as an antineoplastic endocrine therapy on 2013-05-29.

News from Health Canada…

Health Canada

Announcement: The Honourable Leona Aglukkaq, Minister of Health, accompanied by the Honourable Minister Steven Blaney, Minister of Veterans Affairs and Minister for La Francophonie, announced the Harper Government has introduced the Respect for Communities Act, which would require any potential applications for supervised drug consumption sites in Canada to meet clear criteria before such applications can be considered.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2013/2013-76-eng.php

Announcement: Today, the Honourable Leona Aglukkaq, Minister of Health, announced new regulations that will change the way Canadians access marihuana for medical purposes. The new Marihuana for Medical Purposes Regulations (MMPR) will be published in the Canada Gazette, Part II, on June 19, 2013.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2013/2013-79-eng.php

Information Update: Health Canada has reviewed the safety of prescription pain and cough medications containing codeine and is no longer recommending their use in children less than 12 years of age. This recommendation is based on very rare cases of serious side effects and deaths in children that have been attributed to codeine, when given directly to a child, or to babies from breast milk.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/33915a-eng.php

Information Update: Health Canada is advising Canadians that Vita Health Products Inc. is voluntarily recalling all lots of Safeway Extra Strength Ibuprofen Liquid Capsules (400 mg capsules, 50 in a bottle). The recall is due to a labeling error that incorrectly states the product is packaged with a child-resistant bottle and cap.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/33929a-eng.php

Natural Health Products Directorate (NHPD)

Consultation: The Natural Health Products Directorate (NHPD) is seeking your feedback on five newly proposed monographs and one revised monograph for ingredients.
http://www.hc-sc.gc.ca/dhp-mps/consultation/natur/pre-cleared_information_preautorisee-110613-eng.php

Therapeutic Products Directorate (TPD)

 Heath Care Professional Advisory

Intralipid: Fresinius Kabi AB, in collaboration with Health Canada, would like to inform you about important missing information on the French label regarding "Contraindications" and "Warnings" in the Product Information Leaflet and "Cautions" on the pouch label for Intralipid 10%, 20% and 30% Fat Emulsion for intravenous infusion indicated for nutritional supplementation.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/33987a-eng.php

 Consumer Health Advisory

Intralipid: Fresenius Kabi AB, in collaboration with Health Canada, would like to inform you about important missing information about allergic reactions on the French versions of the label in the Product Information Leaflet and on the pouch label for Intralipid 10%, 20% and 30% Purified Lipids (Fat) for IV nutrition.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/33993a-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)

Notice: The Commissioner of Patents has approved practice guidance for the examination of patent applications featuring medical use claims following the March 2013 release of the Patent Notice on Practice Guidance Following the Amazon FCA Decision.
http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr03662.html

Patented Medicine Prices Review Board (PMPRB)

Reminder: The PMPRB has proposed changes to its CPI Adjustment Methodology and to the Patented Medicines Regulations.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=328
 

~~~~~

HEADS UP - May 27, 2013


Notices of Compliance - May 20 – May 24, 2013

• There were no new NOCs published this week.

News from Health Canada…

Health Canada

Announcement: Today, the Honourable Leona Aglukkaq, Minister of Health, announced the Harper Government has introduced new fines of up to $25,000 per day for companies who violate orders under the Canada Consumer Product Safety Act (CCPSA).
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2013/2013-73-eng.php

Information Update: In consultation with Health Canada, four companies (Cobalt Pharmaceuticals, Laboratoire Riva, Mylan Pharmaceuticals and Sanis Health) are voluntarily recalling various lots of five prescription drugs (amlodipine, ciprofloxacin, lamotrigine, norfloxacin and telmisartan) from the Canadian market.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/33811a-eng.php

Health Advisory: Two unauthorized health products - "Stiff Nights" and "Stiff 4 Hours" - were tested by Health Canada and were found to contain hidden ingredients (sildenafil and/or tadalafil) that may pose serious risks to the health of Canadians. The products were being sold at Saints N Sinners Ltd, 1715 Centre Street N.W., Calgary, Alberta.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/33831a-eng.php

Health Advisory: Two unauthorized “ExtenZe” products that may pose serious risks to the health of Canadians were being sold by Saints N Sinners Ltd., 1715 Centre Street N.W., Calgary, Alberta. These products are promoted as sexual enhancement products and are labeled to contain ingredients that require they be sold with a prescription in Canada.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/33881a-eng.php

Health Advisory: Eight products labelled as leather cleaners or liquid incense contain, or allege to contain, alkyl nitrites were being sold by Saints N Sinners Ltd, 1715 Centre Street N.W., Calgary, Alberta. These products, commonly known as “poppers” are used by consumers to get “high” and may pose serious risks to health if they are inhaled or swallowed.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/33907a-eng.php

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

http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/33765a-eng.php
(Libigrow XXXtreme, Blue Diamond, Blue Diamond Platinum, Mojo Nights Supreme, and Casanova)

http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/33791a-eng.php
(WOW, Super Power and SLIMDIA Revolution)

http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/33843a-eng.php
(Flutulang, Kapsul Gaut (Asam Urat), and True ProLife Vegrow)

http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/33863a-eng.php
(Jinmaoshiwang tablets, Naturally Kouxan Best Slim capsules, and Majestic Slimming capsules)

Natural Health Products Directorate (NHPD)

Report: NHPD Quarterly Report for the period of January 1, 2013 to March 31, 2013 (Quarter 4 of the 2012-2013 fiscal year) is available.
www.jptcp.com/files/Quarterly_Snapshot_12_13,_Q4_ENG_2.pdf     www.jptcp.com/files/Quarterly_Snapshot_12_13,_Q4__FR_1.pdf

Consultation: The Natural Health Products Directorate (NHPD) is seeking feedback on the issuance of International Trade Certificates (ITCs).
http://www.hc-sc.gc.ca/dhp-mps/consultation/natur/itc-cci-eng.php

Therapeutic Products Directorate (TPD)

Health Care Professional Advisory

Champix & Zyban: Pfizer Canada Inc. and Valeant Canada LP, in collaboration with Health Canada, would like to inform you of revisions to the Product Monographs (PMs) for non-nicotine smoking cessation aids Champix (varenicline tartrate) and Zyban (bupropion hydrochloride). The revised product monographs indicate that thorough consideration should be given to the option of nicotine replacement therapy, prior to a decision to prescribe a non-nicotine treatment.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/33621a-eng.php

Consumer Health Advisory

Champix & Zyban: Pfizer Canada Inc. (manufacturer of Champix) and Valeant Canada LP (manufacturer of Zyban), in collaboration with Health Canada, would like to inform you about safety information for these anti smoking drugs. New information for Champix (varenicline tartrate) and Zyban (bupropion hydrochloride) has been added to the Product Monographs (PMs), the reference documents that healthcare professionals use when prescribing drugs.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/33623a-eng.php

Health Care Professional Advisory

Cetrotide (Cetrorelix for Injection): EMD Serono, A Division of EMD Inc., Canada in consultation with Health Canada, is advising you that there is a potential for vials in four identified lots of Cetrotide 3mg product, that were distributed in Canada during the period October 2011 – March 2013, to have a reconstitution time longer than 3 minutes.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/33847a-eng.php

Consumer Health Advisory

Cetrotide (Cetrorelix for Injection): EMD Serono, a Division of EMD Inc., Canada, in consultation with Health Canada, is advising patients that there is a potential for four lots of Cetrotide® 3mg product (Lot P00005H, P00006F, P00006P and P00007D) to have an increased reconstitution time longer than the standard 3 minutes: in some instances up to 11 minutes.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/33849a-eng.php

Guidance Document: Health Canada is pleased to distribute the finalized Guidance Document for Clinical Trial Sponsors: Clinical Trial Applications which provides guidance to all sponsors (e.g. industry, academic, contract research organization, etc.) seeking authorization to sell or import a drug for the purpose of a clinical trial in Canada. www.jptcp.com/files/TOC_FINAL_ctdcta_ctddec_fra_1.pdf   www.jptcp.com/files/TOC_FINAL_ctdcta_ctddec_eng_1.pdf

Post-Authorization Activity Table: A Post-Authorization Activity Table (PAAT) for Picato is now available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2013_picato_153285-eng.php#paat

Post-Authorization Activity Table: A Post-Authorization Activity Table (PAAT) for Tecfidera is now available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2013_tecfidera_154776-eng.php

Post-Authorization Activity Table: A Post-Authorization Activity Table (PAAT) for Bystolic is now available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2013_bystolic_152353-eng.php#paat

National Interest

Canadian Intellectual Property Office (CIPO)

Agreements: Patent agreements have been signed between China and Canada IP offices which will help Canadian innovators.
http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr03658.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The newsletter, Health Technology Update – Issue 15, discusses various sources of publicly accessible horizon scanning information on new and emerging health technologies.
http://www.cadth.ca/en/products/environmental-scanning/health-technology-update/htupdate-issue-15

National Association of Pharmacy Regulatory Authorities (NAPRA)

News Release: The National Association of Pharmacy Regulatory Authorities (NAPRA) is pleased to lend its support to the Private Member’s Bill (Bill C-523) to amend the Department of Health Act regarding the disclosure of drug shortages
http://napra.ca/Content_Files/Files/NR_Private_Member_Bill_DrugShortages_June2013_Final.pdf
 

 

HEADS UP - May 20, 2013


Notices of Compliance - May 13 – May 17, 2013

• There were no new NOCs published this week.

News from Health Canada…

Health Canada

Announcement: The Honourable Leona Aglukkaq, Minister of Health, today announced the launch of the Government of Canada's new public database of Health Canada-authorized drug clinical trials involving patients, as well as the completion of a joint project to develop new standards for research ethics boards that oversee clinical trials.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2013/2013-70-eng.php

Health Advisory: GlaxoSmithKline Inc. (GSK), in consultation with Health Canada, would like to inform you that a compound referred to as GW501516 is being made available for sale to Canadians via the internet. This compound may be abused by some athletes for performance enhancement. It is not known if the product available via the internet and sold as GW501516 is actually GW501516 or another compound.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/33605a-eng.php

Recall: Health Canada has been made aware of quality concerns with a manufacturer in China that produces acetaminophen (Paracetamol) as an ingredient for health products. Health Canada has identified four products intended for children and infants that contain acetaminophen from this manufacturer. Prestige Brands, which manufactures the final products, is voluntarily recalling all their affected products from the marketplace.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/33607a-eng.php

Therapeutic Products Directorate (TPD)

 Health Care Professional Advisory

Apo-Clindamycin, Clindamycine-150 and Clindamycine-300: Apotex Inc. and Pro Doc Ltée, in consultation with Health Canada, are writing to advise you that the third party fabricator of clindamycin hydrochloride active pharmaceutical ingredient (API) to Apotex Inc. and Pro Doc Ltée may have inadvertently caused trace amounts of quetiapine fumarate to be present in the clindamycin hydrochloride raw material.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/33633a-eng.php

Consumer Health Advisory

Apo-Clindamycin, Clindamycine-150 and Clindamycine-300: Apotex Inc. and Pro Doc Ltée, in consultation with Health Canada, wishes to advise you that their supplier of clindamycin hydrochloride may have inadvertently caused trace amounts of the anti-psychotic drug quetiapine to be present in the clindamycin raw material.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/33635a-eng.php

Summary Basis of Decision: A Summary Basis of Decision is available for Nimenrix.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2013_nimenrix_154290-eng.php

Summary Basis of Decision: A Summary Basis of Decision is available for Arepanrix H5N1.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2013_arepanrix_h5n1_115398-eng.php

Post Authorization Activity Table: A Post-Authorization Activity Table (PAAT) for Stribild is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2013_stribild_152198-eng.php

National Interest

Gazette II

Food and Drugs Act: Regulations amending the Food and Drug Regulations (1663 — Schedule F) are available. Part I of Schedule F to the Food and Drug Regulations (see footnote 1) is amended by adding the following in alphabetical order: Pancreatic extracts, when sold in a dosage form that provides more than 20 000 USP units of lipase activity per dosage unit or indicated for the treatment of pancreatic exocrine insufficiency.
http://www.gazette.gc.ca/rp-pr/p2/2013/2013-05-22/html/sor-dors90-eng.html

Food and Drugs Act: Regulations amending the Food and Drug Regulations (1431 — Schedule F) are available.
http://www.gazette.gc.ca/rp-pr/p2/2013/2013-05-22/html/sor-dors89-eng.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The May 2013 edition of New at CADTH is now available. http://www.cadth.ca/en/media-centre/new-at-cadth/new-at-cadth-may-13

Newsletter: The newsletter, Health Technology Update – Issue 14, discusses new and emerging medical devices and procedures for the treatment of diabetes, arthritis, glaucoma, gastroesophageal reflux disease, and peripheral artery disease.
http://www.cadth.ca/en/publication/3746
 

~~~~~

HEADS UP - May 13, 2013


Notices of Compliance - May 6 – May 10, 2013

• There were no new NOCs published this week.

News from Health Canada…

Health Canada

Advisory: Today, Health Canada published a recall related to a number of novelty magnet sets marketed to adults that contain small, powerful magnets which can be easily swallowed or inhaled by children.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2013/2013-66-eng.php

Announcement: Health Canada approved proposals from Canadian Blood Services (CBS) and Héma-Québec (HQ) to change the blood donor deferral period for men who have sex with men (MSM) from a lifetime deferral to five years.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2013/2013-65-eng.php

Health Advisory: In consultation with Health Canada, three companies (Cobalt Pharmaceuticals Company, Laboratoires Riva Inc. and Sanis Health Inc.) are voluntarily recalling all lots of their antipsychotic product (Quetiapine) due to potential contamination with an antibiotic product (Clindamycin) during the manufacturing process. The recall affects the 25 mg, 100 mg, 200 mg and 300 mg doses of Co Quetiapine, Riva Quetiapine, and Sanis Quetiapine.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/29291a-eng.php

Health Advisory: Health Canada has been made aware of three products (“Rochefort”, “Rush” and “Amsterdam Special”), commonly known as “poppers”, labelled to contain alkyl nitrites . These products, labelled as leather cleaners and/or liquid incense, are known to be used by consumers to get “high” and may pose serious risks to health if they are inhaled or swallowed.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/29269a-eng.php

Information Update: Health Canada’s review of the safety of the anti-acne medication Diane-35 has found that the drug’s benefits continue to outweigh the risks, when used as authorized.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/29283a-eng.php

HPFB Inspectorate

Summary: A summary of The Quality System Framework (QSF) outlines a quality system approach for compliance and enforcement activities shared by Health Products and Food Branch (HPFB) and Regions and Programs Bureau (RAPB) of Health Canada is available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/activit/qsf-csq-eng.php

(Quality System Framework)  www.jptcp.com/files/QSF__English_version.pdf

Therapeutic Products Directorate (TPD)

 Health Care Professional Advisory

Thalomid (thalidomide capsules): Information on second cancers has been added to the Warnings and Precautions and Consumer Information sections of the Thalomid Canadian product monograph.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/29245a-eng.php

Consumer Health Advisory

Thalomid (thalidomide capsules): Celgene Inc., in discussion with Health Canada, would like to inform you of important safety information related to the risk of second cancers with Thalomid (thalidomide capsules).
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/29249a-eng.php

 Health Care Professional Advisory

Sanis Quetiapine: Sanis Health Inc., in consultation with Health Canada, is writing to advise you that the supplier of quetiapine fumarate active pharmaceutical ingredient (API) to Sanis Health Inc. may have inadvertently caused trace amounts of clindamycin hydrochloride to be present in the quetiapine raw material.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/29303a-eng.php

Health Care Professional Advisory

Riva-Quetiapine: Laboratoire Riva Inc., in consultation with Health Canada, is writing to advise you that the supplier of quetiapine fumarate active pharmaceutical ingredient (API) to Laboratoire Riva Inc. may have inadvertently caused trace amounts of clindamycin hydrochloride to be present in the quetiapine raw material
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/29297a-eng.php

Health Care Professional Advisory

Co Quetiapine: Cobalt Pharmaceuticals Company, in consultation with Health Canada, is writing to advise you that the supplier of quetiapine fumarate active pharmaceutical ingredient (API) to Cobalt Pharmaceuticals Company may have inadvertently caused trace amounts of clindamycin hydrochloride to be present in the quetiapine raw material
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/29295a-eng.php

 Health Care Professional Advisory

Magnesium Sulfate Injection: Pharmaceutical Partners of Canada Inc. (PPC), in consultation with Health Canada, has initiated a voluntary recall of Magnesium Sulfate Injection, USP Lot 6103881 (DIN 02139499) due to potential for glass particles.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/29309a-eng.php

 Health Care Professional Advisory

Zithromax/Zmax SR: Pfizer Canada Inc., in collaboration with Health Canada, would like to inform you of revisions to the Product Monographs for Zithromax and ZMAX SR (azithromycin) regarding the risk of potentially fatal cardiac arrhythmias.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/29199a-eng.php

Consumer Health Advisory

Zithromax/Zmax SR: Pfizer Canada Inc., in collaboration with Health Canada, would like to inform you of additional safety information regarding the risk of potentially fatal irregular heartbeats with the two marketed medicines Zithromax and ZMAX SR.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/29201a-eng.php

Notice to Hospitals

Covidien Surgical Stapler Reloads: Covidien Canada, in collaboration with Health Canada, is issuing this notification to inform health professionals of stolen, non-sterile Endo GIA Articulating 60-3.5mm surgical stapler reloads.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/32195a-eng.php

Post-Authorization Activity Table: A Post-Authorization Activity Table (PAAT) for Esbriet is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2012_esbriet_153849-eng.php

National Interest

Advertising Standards Canada (ASC)

Newsletter: The ASC Spring 2013 Newsletter is available.
http://www.adstandards.com/en/ASCLibrary/newsletters/spring2013/newsletter_ASCNews.aspx

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The newsletter, CDR Update – Issue 88 discusses news on the reinstatement of pre-submission meetings and an update to the procedures regarding Category 2 requirements.
http://www.cadth.ca/en/products/cdr/cdr-update/cdr-update-88?utm_source=cdr-update88&utm_medium=webmail&utm_campaign=e-alert-05-16-13

Workshop: Registration is open for the CADTH Workshop, Critical Appraisal 101: Evidence Appraisal for Non-Researchers, at the Canadian Pharmacists Association conference on June 1, 2013.
http://www.cadth.ca/en/media-centre/e-alert/e-alert-05-21-13

Consultation: CADTH is pleased to invite all interested parties to provide feedback on the draft science report for our project on the management of relapsing-remitting multiple sclerosis. The deadline to submit feedback is Wednesday, June 5, 2013.
http://www.cadth.ca/en/products/therapeutic-reviews/relapsing-remit-multiple-sclerosis/call-for-feedback?utm_source=ms-feedback&utm_medium=webmail&utm_campaign=e-alert-05-22-13

Schedule: The Human Drug Advisory Panel (HDAP) schedule for 2014 is now available.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=327

Patented Medicine Prices Review Board (PMPRB)

Notice and Comment: The Board is seeking your comments on the proposed changes to the CPI Adjustment Methodology and Filing Requirements.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=326
 

~~~~~

HEADS UP - May 8, 2013


Notices of Compliance - April 29 – May 3, 2013

• There were no new NOCs published this week.

News from Health Canada…

Therapeutic Products Directorate (TPD)

 Notice to Hospitals

Cathflo: Hoffmann-La Roche Limited (Roche), in consultation with Health Canada, would like to inform you that visible rubber stopper particulates have been observed in some vials of CATHFLO (alteplase) after reconstitution.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/29103a-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 Stivarga.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2013_stivarga_157970-eng.php
 

~~~~~

HEADS UP - April 29, 2013


Notices of Compliance - April 22 – 26, 2013

• There were no new NOCs published 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 have been amended to extend the requirements for Good Manufacturing Practices (GMP) to active ingredients (AI) used in pharmaceutical drugs. These amendments will come into force in the fall of this year.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2013/2013-58-eng.php

Therapeutic Products Directorate (TPD)

 Notice to Hospitals

FL14E Rose Bed: Stryker Canada, in collaboration with Health Canada, is providing this Notice to inform you on the risk of siderail collapse with the hospital bed - FL14E Rose Bed. It was reported that the siderail may appear latched in the upright position when it is not fully locked in place and may unexpectedly collapse if a pressure is applied on it
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/28927a-eng.php

Consumer Health Advisory

FL14E Rose Bed: Stryker Canada, in collaboration with Health Canada, has issued a Notice to Hospitals regarding the Rose Bed, a hospital bed used in healthcare facilities. It was reported that the siderail may appear latched in the upright position when it is not fully locked in place and may suddenly collapse if a pressure is applied on it.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/28935a-eng.php

Notice to Hospitals

Alenti Lift and Hygiene Chair: ArjoHuntleigh, in collaboration with Health Canada, is providing this notice to re-iterate safety information to prevent the risk of chair tipping and patient falls with the Alenti Lift and Hygiene chair.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/29019a-eng.php

Consumer Health Advisory

Alenti Lift and Hygiene Chair: ArjoHuntleigh, in collaboration with Health Canada, has issued a Notice to Hospitals regarding the Alenti Lift and Hygiene chair. The chair is used in healthcare facilities for lifting and transporting patients to the bathroom and to assist with the bathing process.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/29021a-eng.php
 
Updates: Product Monograph Brand Safety Updates are available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/databasdon/pm_saf_mp_innoc/lab_safety_rep_rap_eval_etiq-eng.php

Summary Basis of Decision: A Summary Basis of Decision is available for Myrbetriq.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2013_myrbetriq_153806-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)

Announcement: Advertising Standards Canada announces 2013/2014 Board of Directors.
http://www.adstandards.com/en/MediaAndEvents/2013BoardOfDirectorsPressRelease.aspx

Annual Report: The Advertising Standards Canada released its 2012/2013 Annual Report highlighting the year’s initiatives.
http://www.adstandards.com/en/AboutASC/2013AnnualReport.pdf

Report: Advertising Standards Canada (ASC) released its Ad Complaints Report – 2012 Year in Review. The Report provides information about consumers’’ complaints submitted to ASC in 2012 for review under the Canadian Code of Advertising Standards.
http://www.adstandards.com/en/MediaAndEvents/2012complaintsReportPressRelease.pdf

Canadian Agency for Drugs and Technologies in Health (CADTH)

Consultation: Later this month, a draft science report from CADTH’s therapeutic review on the management of relapsing-remitting multiple sclerosis will be posted on the CADTH website for stakeholder feedback. All interested parties will have 10 business days to provide their feedback and comments.
http://www.cadth.ca/en/media-centre/e-alert/e-alert-04-29-13

 

~~~~~

HEADS UP - April 22, 2013


Notices of Compliance - April 15 – 19, 2013

• There were no new NOCs published this week.

News from Health Canada…

Health Canada

Announcement: The Minister of Health Responds to Chapter 5 of the 2013 Spring Report of the Auditor General of Canada: Promoting Diabetes Prevention and Control.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2013/2013-53-eng.php

Information Update: Health Canada is informing Canadians and Canadian health care professionals of the risk of eye injury associated with the improper use of contact lens cleaning and disinfecting solutions that contain 3% hydrogen peroxide.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/28539a-eng.php

Natural Health Products Directorate (NHPD)

Consultation: The Natural Health Products Directorate (NHPD) is seeking your feedback on six newly proposed monographs.
http://www.hc-sc.gc.ca/dhp-mps/consultation/natur/pre-cleared_information_preautorisee-300413-eng.php

Therapeutic Products Directorate (TPD)

 Health Care Professional Advisory

Avastin: 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. Cases of necrotizing fasciitis have been reported in patients receiving the anti-cancer drug Avastin.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/28921a-eng.php

Consumer Health Advisory: Hoffmann-La Roche Limited (Roche), in consultation with Health Canada, has informed healthcare professionals of important new safety information regarding the use of Avastin (bevacizumab). Cases of severe bacterial infection of skin and soft tissue (Necrotizing Fasciitis) have been reported with Avastin.
 http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/28923a-eng.php

 Consumer Health Advisory

Thalomid: Celgene Inc., in discussion with Health Canada, would like to inform you of important information related to the risk of blood clots in the arteries with Thalomid (thalidomide capsules).
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/26873a-eng.php

Notice: New requirements for submitting administrative drug submissions to Health Canada are now available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/announce-annonce/admin_subs_notice_avis_admin_pres-eng.php

Notice: Health Canada has issued a Notice to inform clinical trial sponsors that Health Canada will publish information about all clinical trial applications (CTAs) authorized as of April 1, 2013, for the study of drugs in patients.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/announce-annonce/ct_notice_ec_avis-eng.php

Consultation: Health Canada is conducting an open consultation on the draft statement: Nutrition for Healthy Term Infants - Recommendations from Six to 24 Months.
http://www.hc-sc.gc.ca/fn-an/consult/infant-nourrisson6-24/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)

Evaluation: CADTH has posted the 2012 evaluation of the CADTH patient input process undertaken by SECOR, an independent consultant, and the 2013 CADTH Management response to the consultant’s findings and recommendations.
http://www.cadth.ca/en/media-centre/e-alert/e-alert-03-26-13

Patented Medicine Prices Review Board (PMPRB)

Newsletter: The April 2013 edition of the PMPRB NEWSletter is available.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=324

Notice: The Hearing Panel released the Board Order in the matter of Galderma Canada Inc. and the medicine.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=323
 

~~~~~

HEADS UP - April 15, 2013


Notices of Compliance - April 8 – 12, 2013

• Perjeta (trastuzumab, pertuzumab) was approved as an antineoplastic on 2013-04-12.

• Perjeta (Perjeta-Herceptin Combo Pack) (trastuzumab, pertuzumab) was approved as an antineoplastic on 2013-04-12.

News from Health Canada…

Health Canada

Announcement: Health Canada today provided direction to organizations involved in the compounding and admixing of medications that will allow them to continue providing these services while Health Canada and the provinces and territories work together to determine the proper long-term oversight of these activities.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2013/2013-51-eng.php
 
Announcement: Health Canada has released its Second Report on Human Biomonitoring of Environmental Chemicals in Canada.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2013/2013-49-eng.php

Announcement: As Minister of Health, I am pleased to convey our government's support for the motion introduced in the House of Commons by Member of Parliament Dean Allison, Motion 230, which seeks to raise awareness of severe allergic reactions or anaphylaxis.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2013/2013-52-eng.php

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

http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/26795a-eng.php
(Diet Garcinia Forte, Shan Dian Shou, and Aulura Energy Dietary Supplement)

http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/26785a-eng.php
(Snake Powder Capsule for Rheumatism, Jia Rong Zhuang Gu Tong Bi Jiaonang, and Long Ren Tang Fu She Gu Rang Jiao Nang)

http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/26789a-eng.php
(Tinea Schwartz's, Tiao Jing Bu Xue Pills, and Yeung Ng Tong Tin Hee Pills)

http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/26791a-eng.php
(Quan Xie Jin Gu Tong, Xinhuang Pian and Jin Gu Feng Shi Kang Jiao Nang)

Therapeutic Products Directorate (TPD)

 Health Care Professional Advisory

Flolan: GlaxoSmithKline Inc., in consultation with Health Canada, would like to inform you that some vials of Sterile Diluent for Flolan have been found to contain glass-related particles that may form because of an interaction between the surface of the glass vial container and the Sterile Diluent for Flolan.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/26805a-eng.php

Consumer Health Advisory

Flolan: GlaxoSmithKline Inc., in consultation with Health Canada, is providing Canadians with updated information on the use of the pulmonary hypertension drug, Flolan.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/26807a-eng.php

Notice to Hospitals

Dexamethasone Sodium Phosphate Injection USP: Sandoz Canada Inc. has initiated a voluntary recall of one lot of Dexamethasone Sodium Phosphate Injection USP 10 mg/mL (lot CH1607 (expiry: 02/2015)) due to the observation of visible particulate matter in some vials of this lot.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/26803a-eng.php

Notice: Validation rules for regulatory transactions submitted to Health Canada in the electronic Common Technical Document (eCTD) format are available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ctd/ectd/ectd_valid_rev_v0.2a_notice_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

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

Consultation: The Canadian Agency for Drugs and Technologies in Health (CADTH) is undertaking an optimal use project that will include several components providing evidence-based information to assist in the management of the Point-of-care (POC) technology and is seeking feedback from interested stakeholders at key stages during this project.
http://www.cadth.ca/en/products/optimal-use/poc-inr

Pharmaceutical Advertising Advisory Board (PAAB)

Newsletter: The April 2013 issue of the PAAB Views is available.
http://www.paab.ca/resources/newsletters/PAAB_views_april_2013_en.pdf
 

~~~~~

HEADS UP - April 7, 2013


Notices of Compliance - April 1 – 5, 2013

• Fycompa (perampanel) was approved as an antiepileptic agent on 2013-04-04.

• Tecfidera (dimethyl fumarate) was approved as an other nervous system drug

News from Health Canada…

Health Canada

Announcement: The Honourable Leona Aglukkaq, Minister of Health, hosted a meeting in Ottawa today with concerned parents and community members to outline action that will be taken by the Harper Government in the coming months to help support the health and safety of Canadian families.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2013/2013-48-eng.php

Announcement: Partners in Canada's blood system met with key stakeholders yesterday in Toronto to discuss the issue of paid plasma donations and the potential impact on Canada's blood system.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2013/2013-45-eng.php

Announcement: Today, Parliamentary Secretary of Health, Dr. Colin Carrie highlighted the ongoing success of Health Canada's more efficient approach to natural health products (NHPs), with more than 60,000 products authorized.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2013/2013-46-eng.php

Recall: Further to the previous recall posted on April 8, 2013, Apotex is recalling additional lots of Alysena-28 birth control pills as a precautionary measure.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/26793r-eng.php

Information Update: Health Canada has been informed by Apotex Inc. that the company will be recalling additional lots of Alysena-28 birth control pills as a precautionary measure while it investigates why one lot of the product contained packages with extra placebo pills in place of active pills. Packages of Alysena-28 should have three rows of pink (active) pills and only one row of white (placebo) pills.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/26769a-eng.php

Biologics and Genetic Therapies Directorate (BGTD)

Notice: The BGTD has published information on plasma donation in Canada.
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/activit/fs-fi/plasma-eng.php

Therapeutic Products Directorate (TPD)

 Health Care Professional Advisory

Tasigna: Novartis Pharmaceuticals Canada Inc. (“Novartis”), in collaboration with Health Canada, would like to inform you of important information regarding reports of atherosclerosis-related diseases in patients treated with Tasigna (nilotinib).
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/26651a-eng.php

Consumer Health Advisory

Tasigna: Novartis Pharmaceuticals Canada, Inc. (Novartis), in collaboration with Health Canada, would like to inform you about important safety information regarding reports of atherosclerosis-related conditions in patients treated with Tasigna (nilotinib).
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/26659a-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

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 April 2013 issue of the Canadian Adverse Reaction Newsletter published by the Marketed Health Products Directorate, Health Products and Food Branch is now available.
http://www.hc-sc.gc.ca/dhp-mps/medeff/bulletin/carn-bcei_v23n2-eng.php

Summary Basis of Decision: A Summary Basis of Decision is available for Adcetris.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2013_adcetris_154851-eng.php

National Interest

Patented Medicine Prices Review Board (PMPRB)

Voluntary Compliance Undertaking: The Chairperson of the Board accepted a Voluntary Compliance Undertaking (VCU) for Novolin.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=322

National Association of Pharmacy Regulatory Authorities (NAPRA)

National Drug Schedules: The Initial Recommendation made by the National Drug Scheduling Advisory Committee (NDSAC) on March 7, 2013, that bisacodyl and its salts in all forms and strengths be retained in Schedule III, was finalized effective April 10, 2013.
http://napra.ca/pages/home/default.aspx?id=3201

Meeting: The proposed meeting of the National Drug Scheduling Advisory Committee (NDSAC) for June 9 and 10, 2013 is cancelled.
http://napra.ca/pages/home/default.aspx
 

~~~~~

HEADS UP - April 1, 2013


Notices of Compliance - March 25 – 29, 2013

• There were no new NOCs published this week.

News from Health Canada…

Health Canada

Announcement: Today, Parliamentary Secretary of Health, Dr. Colin Carrie attended the second meeting of the Advisory Council on Traditional Chinese Medicine (TCM), on behalf of the Honourable Leona Aglukkaq, Minister of Health.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2013/2013-44-eng.php

Recall: XPN Canada (E.H. Supplement Inc.) is recalling their product Crazy Geranium due to lack of market authorization.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/26745r-eng.php

Recall: Apotex Inc.’s Alysena 28 has been recalled. The packaged product may contain two rows of placebo tablets (14 tablets) and two rows of active contraceptive tablets (14 tablets) in the blister pack. Correct packaging is one row of placebo tablets (7 tablets) and three rows of active contraceptive tablets (21 tablets) in the blister pack.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/26663r-eng.php

Information Update: Health Canada is encouraging Canadians to play a role in identifying hazards in consumer products and reporting problems as soon as possible to the manufacturer, the retailer or to Health Canada.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/26649a-eng.php

Information Update: Health Canada is informing Canadians and Canadian health care professionals of the potential risk of bone fractures associated with the use of drugs known as proton pump inhibitors. Proton pump inhibitors (PPIs) are drugs used to reduce stomach acid and are widely used to treat conditions such as acid reflux (heartburn) and stomach ulcers.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/26523a-eng.php

Natural Health Products Directorate (NHPD)

Notice: The electronic Product Licence Application form (ePLA) has undergone a revision and its functionality has been improved to deliver a better application experience when applying for Natural Health Product licences. The form has been released and is available for use on the Natural Health Products Directorate (NHPD) website.
www.jptcp.com/files/NHPD_Licence_Application.pdf

Therapeutic Products Directorate (TPD)
 
Notice to Hospitals

HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems: Baxter, in conjunction with Health Canada is providing this notice to reinforce the importance of proper programming to reduce the potential for unintended Increased Intraperitoneal Volume (IIPV) or overfill of the abdomen in patients using the HomeChoice and HomeChoice PRO APD Systems.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/26519a-eng.php

Consumer Health Advisory

HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems: Baxter and Health Canada are providing this notice to highlight the importance of proper use with the HomeChoice APD Systems.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/26521a-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

Label Safety Assessment Update: A number of documents regarding the Label Safety Assessment Update are available.

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/databasdon/pm_saf_mp_innoc/lab_safety_rep_rap_eval_etiq-eng.php
(Product Monograph Brand Safety Updates)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/databasdon/pm_saf_mp_innoc/lab_safe_memo_avis_innoc_etiq-eng.php
(Notice - Notification of Safety Labelling Changes to the Product Monographs of Pharmaceutical Drug Products)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/databasdon/pm_saf_mp_innoc/lab_safety_att_eval_etiq-eng.php
(Label Safety Assessment Update - Sponsor Attestation)

Notice: Adoption of the International Conference on Harmonisation (ICH) Guidance on Periodic Benefit Risk Evaluation Report - ICH Topic E2C(R2), as of March 1, 2013 is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ich/efficac/e2cr2_notice_avis-eng.php

Document: Questions and Answers Regarding the Adoption of Periodic Benefit Risk Evaluation Report (PBRER) Review at Health Canada is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ich/efficac/e2cr2_qa_qr-eng.php

National Interest

Gazette II

Food and Drug Regulations: Regulations amending the Food and Drug Regulations (1733 — Clinical Trials — Miscellaneous Program) are available.
http://www.gazette.gc.ca/rp-pr/p2/2013/2013-04-10/html/sor-dors56-eng.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The March 2013 edition of New at CADTH is available.
http://www.cadth.ca/en/media-centre/new-at-cadth/new-at-cadth-march-13

Patented Medicine Prices Review Board (PMPRB)

Notice: Robert Goldwin Elgie, former Chair of the PMPRB, remembered.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=321

Reports: The PMPRB under the NPDUIS initiative (National Prescription Drug Utilization Information System) released two new analytical reports on April 5, 2013.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=320
 

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HEADS UP -March 25, 2013


Notices of Compliance - March 18 – 22, 2013

• Neupro (rotigotine) was approved as an antiparkinsonian agent; dopamine agonist on 2013-03-21.

News from Health Canada…

Health Canada

Announcement: The Honourable Leona Aglukkaq, Minister of Health, today reaffirmed that the Canada Health Transfer (CHT) will reach a record high level of $30.3 billion in 2013–14, providing provinces and territories with long-term, predictable and sustainable funding to support the effective front-line delivery of health care services to Canadians and their families.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2013/2013-40-eng.php

Recall: The Serrad 100 Cassette Liq. 58% has been recalled. The packaging printing bar code error will result in the Sterrad 100S System rejecting cassettes that are part of Lot#12F044.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/26485r-eng.php

HPFB Inspectorate

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

Guidance Document: The Guidance Document 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

Document: The document ‘Frequently Asked Questions (FAQ's) - Drug Establishment Licensing and Fees’ is available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/ren-doc/del-lepp-faq-eng.php

Document: The document ‘Frequently Asked Questions - Medical Device Establishment Licensing and Fees’ is available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/ren-doc/faq-eng.php


Natural Health Products Directorate (NHPD)

Consultation: The Natural Health Products Directorate (NHPD) is announcing the final posting of the monographs for: Carrot, Holy basil – seed, Holy basil – leaf, Sage – buccal & topical and Sage – oral. The Sage and Holy basil monographs have been revised based on stakeholder feedback received during the 30 day consultation period from September 25, 2012 to October 24, 2012 & October 23, 2012 – November 22, 2012 respectively.
www.jptcp.com/files/NHPD_email._April_3_2013.pdf

Therapeutic Products Directorate (TPD)

Consultation: Health Canada is pleased to announce the release of Draft Guidance Document: Disinfectant Drugs (2013) for a 60-day stakeholder consultation.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult_draft_disinf_ebauche_desinf-eng.php

(Draft Guidance Document: Disinfectant Drugs (2013)  www.jptcp.com/files/draft_disinf_ebauche_desinf_eng_1.pdf

Notice: A Notice has been issued regarding the classification of non-medicated eyewashes.
http://www.hc-sc.gc.ca/dhp-mps/dev-drug-instr-drogue/eyewash_notice_avis_rinc_yeux-eng.php

Summary Basis of Decision: A Summary Basis of Decision is available for Bystolic.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2013_bystolic_152353-eng.php

Summary Basis of Decision: A Summary Basis of Decision is available for Picato.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2013_picato_153285-eng.php

Summary Basis of Decision: A Summary Basis of Decision is available for Diacomit.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2013_diacomit_142417-eng.php

National Interest

Canadian Intellectual Property Office (CIPO)

Deposit Accounts: As of April 1, 2013, CIPO accepts only the following payment options for replenishing deposit accounts: online banking, wire transfer, cheque, money order, debit card or cash (in person at Headquarters only).
http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr03641.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The newsletter, CDR Update – Issue 87, discusses changes to the procedure for posting CDR Clinical and Pharmacoeconomic Reviews on the CADTH website.
http://cadth.ca/en/products/cdr/cdr-update/cdr-update-87?utm_source=cdr-update&utm_medium=webmail&utm_campaign=e-alert-03-27-13

Report: Final science and recommendations reports are now available for the optimal use project on high-sensitivity cardiac troponin for the rapid diagnosis of acute coronary syndrome in the emergency department.
http://www.cadth.ca/en/products/optimal-use/high-sensitivity-troponin/reports?utm_source=Troponin-report&utm_medium=webmail&utm_campaign=e-alert-04-01-13

 

HEADS UP - March 18, 2013


Notices of Compliance- March 11 – 15, 2013

• Stivarga (regorafenib) was approved as a multikinase inhibitor; antineoplastic on 2013-03-11.

News from Health Canada

Health Canada

Recall: The OneTouch Verio IQ Blood Glucose Meter will not work as expected at extremely high blood glucose levels of 56.8mmol/L (1023 mg/dL) or above. The OneTouch Verio IQ will not display a result and will not write to memory. The meter will countdown then turn off instead of displaying a result.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/26407r-eng.php

Biologics and Genetic Therapies Directorate (BGTD)

Report: The Biologics and Genetic Therapies Directorate Directorate Drug Submission Performance Quarterly Report; October – December 2012 is available.
www.jptcp.com/files/bgtd_dpbtg_12_oct_dec_eng.pdf

Therapeutic Products Directorate (TPD)

Health Care Professional Advisory

Duodopa: AbbVie Corporation is pleased to announce that Health Canada has issued a marketing authorization with conditions under the Notice of Compliance with Conditions (NOC/c) policy to Duodopa (levodopa/carbidopa intestinal gel), for use in the treatment of advanced levodopa-responsive Parkinson's disease when satisfactory control of severe, disabling motor fluctuations and hyper-/dyskinesia cannot be achieved with available combinations of Parkinson medicinal products.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/duodopa_dhcpl_lapds_158346-eng.php

Health Care Professional Advisory

Tykerb: GlaxoSmithKline Inc., in consultation with Health Canada, would like to inform you of important study results concerning the efficacy of Tykerb. Recently, there have been results reported from two comparative studies of Tykerb in combination with chemotherapy versus Herceptin (trastuzumab) in combination with chemotherapy in HER2+ metastatic breast cancer patients.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/26285a-eng.php

Consumer Health Advisory

Tykerb: GlaxoSmithKline Inc., in consultation with Health Canada, is providing Canadians with updated information on the use of the cancer treatment drug, Tykerb. For breast cancer patients with metastatic breast cancer that is HER 2 positive, two recent studies have shown that use of Tykerb in combination with chemotherapy is less effective than the use of Herceptin in combination with chemotherapy.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/26287a-eng.php

Report: The Therapeutic Products Directorate Drug Submission Performance Quarterly Report; October – December 2012 is available.
www.jptcp.com/files/tpd_dpt_12_oct_dec_eng_3.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

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The newsletter, CDR Update – Issue 86, discusses news about temporary changes to the submission process.
http://www.cadth.ca/en/products/cdr/cdr-update/cdr-update-86?utm_source=cdr-update&utm_medium=webmail&utm_campaign=e-alert-03-22-13

Reports: Final science and recommendations reports are now available for the therapeutic review Antithrombotic Therapy for Patients With Atrial Fibrillation.
http://www.cadth.ca/en/products/therapeutic-reviews/antithrombotic-therapy/reports?utm_source=Antithrombotic-report&utm_medium=webmail&utm_campaign=e-alert-03-25-13

Patented Medicine Prices Review Board (PMPRB)

Presentation: Michelle Boudreau, Executive Director, delivered a presentation at the Pharma Pricing and Market Access Outlook Europe 2013 conference in London, UK.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=1511&id=319
 

HEADS UP - March 11, 2013


Notices of Compliance - March 4 – 8, 2013

• Myrbetriq (mirabegron) was approved as a selective beta-3 andrenoreceptor agonist on 2013-03-06.

• Nimenrix (meningococcal polysaccharide antigen group A, meningococcal polysaccharide antigen group C, meningococcal polysaccharide antigen group W-135, meningococcal polysaccharide antigen group Y, tetanus toxoid) was approved as an active immunizing agent on 2013-03-05.

News from Health Canada…

Health Canada

Announcement: The Government of Canada, along with the consumer product safety agencies in the United States and Mexico, are reminding parents and caregivers about the dangers of poison during Poison Prevention Week 2013 (March 17-23). 
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2013/2013-37-eng.php

Announcement: Health Canada and France's Agency for Food, Environmental and Occupational Health and Safety (ANSES) signed a new framework cooperation agreement on January 15, 2013. This agreement reinforces the long-standing relations between the two agencies and follows the cooperation agreement signed in July 2008.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2013/2013-38-eng.php

Information Update: Health Canada and manufacturers are strengthening the labelling and instructions for the use of spray fibrin sealants following three deaths outside of Canada. Fibrin sealants, also known as topical hemostatic agents, are used during surgery to help reduce local bleeding.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/26173a-eng.php

Health Advisory: An unauthorized natural health product, “Libigrow” was tested by Health Canada and found to contain hidden ingredients (sildenafil and tadalafil) that may pose serious risks to the health of Canadians. “Libigrow” was being sold at two retail locations in the province of Québec: Boutique Sexie folie Inc. (Sainte-Catherine) and at Boutique Érotique 5ième avenue Inc. (Valleyfield).
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/26185a-eng.php

HPFB Inspectorate

Form: Good Manufacturing Practices: Foreign Site Submission Form: Section 5 (FRM-0212) is available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/form/gui-0080-form-0212-eng.php

Form: Part C: Canadian Warehouse Form is available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/ren-doc/warehouse-entrepot_form-eng.php

Chart: The Drug Establishment Licence Fee Calculation Chart is available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/directives/calcul-chart_del-lepp-eng.php

Checklist: The 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

Therapeutic Products Directorate (TPD)

 Health Care Professional Advisory

Rifadin: Following a review of a limited number of Rifadin retain samples, a low number of 150 mg capsules were found to have a low fill weight. Based on this information, Sanofi Canada has decided to initiate a voluntary recall of the single lot impacted (lot 3099036) as a precautionary measure.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/26171a-eng.php

Notice to Hospitals

Hospira infusion pumps: Hospira Healthcare Corporation, in collaboration with Health Canada, is providing this important information to make you aware of potential safety issues that you may experience with Hospira Symbiq, Plum, Lifecare PCA, and Gemstar infusion pumps.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/26209a-eng.php

Guidance Document: The Guidance Document: Fees for the Review of Drug Submissions and Applications has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/fees-frais/fee_frais_guide-eng.php

Guidance Document: The Guidance Document: Fees for the Right to Sell Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/fees-frais/right_sell_guid_droit_vendre-eng.php

Form: The Drug Submission Fee Application Form has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/form/feef_fraisf-eng.php

Notice: A Notice has been issued to advise that updated fees have been introduced as per the Notice published in the Canada Gazette Part I on March 2, 2013. The fees take effect for new Drug Master File Registrations, Letters of Access and the DMF Biannual Updates received on or after April 1, 2013.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/fees-frais/dmfcost_fmmfrais_2013-eng.php

Form: The Drug Master File (DMF) Fee Form has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/form/dmff_fmmf_2013-eng.php

Guidance Document: The Guidance Document: Fees for the Review of Medical Device Licence Applications has been updated.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/guidedoc_feesmd_docorient_fraisim-eng.php

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

Consultation: Health Canada is seeking your feedback 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/drug-medic/md_stand_im_draft_ebauche_norm_prop_lst-eng.php

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

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

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

Form: The Class III Medical Device Licence Amendment Application Form has been updated.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/md_licam_im_demmhom_cla3-eng.php

Form: The Class IV Medical Device Licence Amendment Application Form has been updated.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/md_licam_im_demmhom_cla4-eng.php

Notice: A Notice has been issued regarding content changes to Notices of Compliance issued for administrative submissions.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/announce-annonce/admin_noc_notice_avis_mod_av-eng.php

Notice: Health Canada is pleased to announce that effective immediately, administrative regulatory activities will be accepted in electronic only format.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/announce-annonce/admin_subs_notice_avis_admin_pres-eng.php

National Interest

Canadian Intellectual Property Office (CIPO)

Report: CIPO's 2011-2012 annual report is now available.
http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr03591.html#intro
 

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HEADS UP - March 4, 2013


Notices of Compliance - February 25 – March 1, 2013

• There were no new NOCs published this week.

News from Health Canada…

Health Canada

Information Update: Following the death of a child enrolled in a clinical trial for the drug Sensipar in the United States, Health Canada is reminding healthcare professionals and consumers that Sensipar is not approved for use in patients under 18 years of age.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/25849a-eng.php

Information Update: Health Canada is informing Canadians and Canadian health care practitioners that Hospira Inc., a drug and medical device manufacturer, is voluntarily stopping all new sales of its intravenous infusion pumps while it addresses issues in its quality management system.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/25869a-eng.php

Natural Health Products Directorate (NHPD)

Consultation: The Natural Health Products Directorate (NHPD) is seeking your feedback on three revised monographs for Echinacea.  In order to facilitate efficient and consistent review of these ingredients in Natural Health Products (NHPs), the NHPD has revised the Echinacea angustifolia, Echinacea pallida and Echinacea purpurea monographs. These three monographs will be published for a 30-day consultation period starting on March 11, 2013 and ending on April 9, 2013.
http://www.hc-sc.gc.ca/dhp-mps/consultation/natur/pre-cleared_information_preautorisee-110313-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/index-eng.php

Meeting: 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/sacnpd_a_ccsmnl_o_2012-11-16-eng.php
(Agenda)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-com/nonpres/sacnpd_rop_ccsmvl_crd_2012-11-16-eng.php
(Record of Proceedings)

Label Safety Assessment Update: Product Monograph Brand Safety Updates are available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/databasdon/pm_saf_mp_innoc/lab_safety_rep_rap_eval_etiq-eng.php

National Interest

Canadian Intellectual Property Office (CIPO)

Patent Notice: The Commissioner of Patents has approved a practice guidance for the examination of patent applications in respect of the Federal Court of Appeal decision in Canada (Attorney General) v Amazon.com Inc., 2011 FCA 328.
http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr03629.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Consultation: CADTH is pleased to invite all interested parties to provide feedback on the updated optimal use recommendations for second- and third-line pharmacotherapy for people with type 2 diabetes.
http://www.cadth.ca/en/products/optimal-use/second-line-therapies/call-for-feedback?utm_source=2nd-3rd-diabetes-feedback&utm_medium=webmail&utm_campaign=e-alert-03-11-13

 

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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
 

 

~~~~~

HEADS UP - February 18, 2013


Notices of Compliance - February 11 – 15, 2013

• Arepanrix H5N1 (haemagglutinin-strain A (H5N1), polysorbate 80, squalene, vitamin E) was approved as an Active Immunizing Agent on 2013-02-13.

News from Health Canada…

Health Canada

Announcement: Today, the Honourable Leona Aglukkaq, Minister of Health and MP James Bezan (Selkirk-Interlake, MB), announced that Health Canada intends to strengthen its health warnings about the dangers of tanning beds.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2013/2013-27-eng.php

Information Update: Sequel Naturals Ltd. is voluntarily recalling three lots of its natural health product “Vega One French Vanilla” in various sizes after testing conducted by Health Canada identified bacteria that could pose a risk to consumers with weakened immune systems.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/23261a-eng.php

Health Advisory: Two unauthorized health products “18 Again” and “Stiff 4 Hours” were tested by Health Canada and were found to contain hidden ingredients (sildenafil or tadalafil) that may pose serious risks to the health of Canadians. The products were being sold at the Unchained Romance booth at the 12th Annual Vancouver Taboo Sex Show.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/23283a-eng.php

Health Advisory: Health Canada is warning consumers about the risks associated with “synthetic marihuana” products sold in Canada, which are typically products containing plant material that has been sprayed or coated with synthetic cannabinoids.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/23621a-eng.php

Therapeutic Products Directorate (TPD)

 Health Care Professional Advisory

Rituxan: Hoffmann-La Roche Limited (Roche), in consultation with Health Canada, would like to inform you of important new safety information associated with Rituxan (rituximab). Severe skin reactions such as Toxic Epidermal Necrolysis (TEN) and Stevens-Johnson Syndrome (SJS) have been reported very rarely in patients who were given Rituxan for the treatment of cancer or disorders of the immune system such as rheumatoid arthritis (RA).
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/23231a-eng.php

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) and its association with severe skin reactions.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/23233a-eng.php

Health Care Professional Advisory

Incivek: Vertex Pharmaceuticals (Canada) Incorporated, in collaboration with Health Canada, would like to inform you of new important safety information regarding serious skin reactions with Incivek (telaprevir) combination treatment.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/23481a-eng.php

Consumer Health Advisory

Incivek: Vertex Pharmaceuticals (Canada) Incorporated, in collaboration with Health Canada, would like to inform you of new important safety information regarding serious skin reactions with Incivek (telaprevir) combination treatment.  Serious skin reactions have been reported in patients taking Incivek combination treatment and have resulted in treatment in a hospital and death.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/23483a-eng.php

Health Care Professional Advisory

Catena: Santhera Pharmaceuticals, in consultation with Health Canada, will voluntarily withdraw Catena from the Canadian market as of April 30, 2013. The withdrawal of Catena is due to the failure to confirm the drug’s benefits in additional studies and is not the result of a specific safety concern.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/23509a-eng.php

Consumer Health Advisory

Catena: Santhera Pharmaceuticals, in consultation with Health Canada, would like to inform you that Catena will no longer be sold in Canada as of April 30, 2013.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/23519a-eng.php

Draft Guidance: Draft (Step 2) International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use Guidance: M7 - Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk is available.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult_m7_step2_notice_etape2_avis-eng.php

Label Safety Assessment Update: A number of documents regarding the Label Safety Assessment Update are available.

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/databasdon/pm_saf_mp_innoc/lab_safe_memo_avis_innoc_etiq-eng.php
(Notification of Safety Labelling Changes to the Product Monographs of Pharmaceutical Drug Products)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/databasdon/pm_saf_mp_innoc/lab_safety_att_eval_etiq-eng.php
(Sponsor Attestation)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/databasdon/pm_saf_mp_innoc/lab_safety_rep_rap_eval_etiq_01_2013-eng.php
(Product Monograph Brand Safety Updates January 2013)

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

Record of Decisions: A Record of Decisions is available for the May 2, 2012 meeting between Health Canada and the Canadian Generic Pharmaceutical Association (CGPA).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/assoc/2012-05-02-eng.php

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

Consultation: In early March, a draft recommendations report will be posted on the CADTH website on second- and third-line pharmacotherapies in type 2 diabetes. There will be 10 business days in which to provide feedback on the report.
http://www.cadth.ca/en/media-centre/e-alert/e-alert-02-22-13

Patented Medicine Prices Review Board (PMPRB)

Presentation: Michelle Boudreau, Executive Director, delivered a presentation at the Pharmacare 2020 conference in Vancouver.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=1511&id=318
 

 

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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
 

 

~~~~~

 

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
 

 

~~~~~

 

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
 

 

~~~~~


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
 

 

~~~~~

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
 


Notices of Compliance - October 22 - 26, 2012

• There were no new NOCs published during this week.

News from Health Canada…

Health Canada

Information Update: Avmor Ltd. has expanded its recall of products to include four additional lots of the product X3 Clean Alcohol-Free Foaming Hand Sanitizer (Benzalkonium chloride 0.13%).
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_166-eng.php

Natural Health Products Directorate (NHPD)

Report: The Cover Letter & NHPD Quarterly Report for the period of July 1, 2012 to September 30, 2012 (Quarter 2 of the 2012-2013 fiscal year) are available.
(See attached)

Therapeutic Products Directorate (TPD)

Health Care Professional Advisory

Infanrix Hexa: GlaxoSmithKline, in consultation with Health Canada, would like to inform you of the decision to voluntarily recall one Lot (A21CB242A) of Infanrix Hexa® vaccine as a result of potential microbial contamination.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2012/infanrix_hpc-cps-eng.php

Consumer Health Advisory

Infanrix Hexa: GlaxoSmithKline, in consultation with Health Canada, would like to inform you of its decision to voluntarily recall one Lot (A21CB242A) of Infanrix Hexa®vaccine as a result of detection of contamination in the environment where material used to make the recalled vaccine had been placed. No contamination was found in the vaccine.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2012/infanrix_pc-cp-eng.php

Notice to Hospitals

Riata and Riata ST Silicone Endocardial Defibrillation Leads: St. Jude Medical Inc., in collaboration with Health Canada, is providing a letter to re-iterate safety information and provide updated patient care resources and recommendations regarding insulation abrasion in Riata and Riata ST defibrillation leads.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2012/riata_nth-aah-eng.php

Notice: The Therapeutic Products Directorate (TPD) has completed an assessment to determine whether the Listing of Drugs Currently Regulated as New Drugs (also known as the New Drugs List) should be updated or removed entirely from the Health Canada website. This is to notify sponsors that the list will not be updated to include any new substances or formulations.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/newdrug-drognouv/ndrugs_ndrogue-eng.php

Form: The Human Cells, Tissues and Organs for Transplantation - Error or Accident Investigation Preliminary Report Form (FRM-0172) has been updated.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/info-prod/cell/frm-0172_doc-eng.php

Summary Basis of Decision: A Summary Basis of Decision is available for Dificid.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2012_dificid_151086-eng.php

National Interest

Gazette II

Copyright Modernization Act: An order fixing various dates as the dates on which various provisions of the Copyright Modernization Act (the Act) come into force has been issued.
http://canadagazette.gc.ca/rp-pr/p2/2012/2012-11-07/html/si-tr85-eng.html

Canadian Intellectual Property Office (CIPO)

Roundtable Discussions: The Canadian Intellectual Property Office (CIPO) will host a series of roundtable discussions with small and medium sized enterprises (SMEs) to better understand their challenges and barriers in using the intellectual property system.
(See attached)

Copyright Registration: CIPO has updated both the application forms for registration of copyright and the Guide to Copyrights to reflect changes from the coming into force of amendments to the Copyright Modernization Act.
http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr03572.html

Copyright Modernization Act: An order fixing various dates as the dates on which various provisions of the Copyright Modernization Act (the Act) come into force has been issued.
http://canadagazette.gc.ca/rp-pr/p2/2012/2012-11-07/html/si-tr85-eng.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Consultation: A draft Issues in Emerging Health Technologies bulletin on inhaled insulin is available for feedback from all interested stakeholders.
http://www.cadth.ca/en/media-centre/2012/11/2/5-call-for-feedback

Newsletter: The CADTH Communiqué, Volume 2, No. 33 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-2-33

Pharmaceutical Advertising Advisory Board (PAAB)

Meeting: ‘The Submissions Guidance Workshop’ will be held in Pickering, Ontario on December 5, 2012.
http://www.paab.ca/events/

Patented Medicine Prices Review Board (PMPRB)

Newsletter: The PMPRB has released its October 2012 NEWSletter.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=303

 

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

 

 

~~~~~

HEADS UP - October 15, 2012


Notice of Compliance - October 8 - 12, 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 the Government of Canada's intention to create a web-based list of Health Canada authorized drug clinical trials in patients.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2012/2012-155-eng.php
 
Health Advisory: Avmor Ltd. has expanded its recall of Antimicrobial Foaming Hand Soap (Triclosan 0.3%) to include 19 additional lots of this product. As a precautionary measure, Avmor Ltd. is also recalling 21 lots of the product X3 Clean Alcohol-Free Foaming Hand Sanitizer (Benzalkonium chloride 0.13%).
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_156-eng.php

Information Update: Health Canada is informing Canadians and Canadian health care practitioners that the labelling for methotrexate and Proton Pump Inhibitors is being updated to include information on a potential interaction between these products.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_157-eng.php

Natural Health Products Directorate (NHPD)

Report: The NHPD Status of Applications Quarterly Report - Quarter 1 (Fiscal year 2012-2013) is available on the NHPD website.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/report-rapport/qar_tri_1-13-eng.php

Updated Web Documents: The NHPD has updated several web documents for its Online Systems tools. This includes updates to the Natural Health Product Online Solution Electronic Product Licence Application user manual and the NHPOLS Trading Partner Guide. The NHPOLS Trading Partner Guide has been expanded to also include guidance on submitting documentation to the NHPD electronically and has been renamed to the How to Interact with the NHPD Electronically guide. 

http://www.hc-sc.gc.ca/dhp-mps/pubs/natur/eplaguide-eng.php
(Natural Health Product Licence Application Form User Manual)

http://www.hc-sc.gc.ca/dhp-mps/pubs/natur/trading_part_commerce-eng.php
(Guidance Document on how to Interact with the Natural Health Products Directorate electronically)

http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/online-enligne/questions-eng.php
(Natural Health Products Online Solution: Frequently Asked Questions)

Consultation: The Natural Health Products Directorate (NHPD) is seeking feedback on four newly introduced monographs for ingredients.  In order to facilitate efficient and consistent review of these ingredients in Natural Health Products (NHPs), the NHPD has developed monographs for the following ingredients:  Bovine colostrum, Carrot (Daucus carota), Holy basil – Leaf (Ociumum tenuiflorum) and Holy basil – Seed (Ociumum tenuiflorum).  The new monographs will be published for a 30-day consultation period starting on October 23, 2012 and finishing on November 22, 2012.
http://hc-sc.gc.ca/dhp-mps/consultation/natur/pre-cleared_information_preautorisee-oct_23-eng.php

Therapeutic Products Directorate (TPD)

Notice: An update on Health Canada’s activities related to the registration and disclosure of clinical trial information is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/proj/enreg-clini-info/cta_regis_notice_avis_dec_rense-eng.php

Document: The document entitled, “Cost-Benefit Analysis: Regulations Amending the Food and Drug Regulations - Good Manufacturing Practices for Active Ingredients” is available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/info-prod/drugs-drogues/actingred-cba-aca-eng.php

Document: The document entitled, “Cost-Benefit Analysis Supplemental - Small Business Lens under the Cabinet Directive on Regulatory Management” is available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/info-prod/drugs-drogues/actingred-cba-aca-suppl-compl-eng.php

Consultation: A Draft Guidance on Good Manufacturing Practices (GMP) for Active Pharmaceutical Ingredients (APIs) Guidelines (GUI-0104) is available.
http://www.hc-sc.gc.ca/dhp-mps/consultation/compli-conform/2012-gui-0104-eng.php

(Health Canada email & Draft Guidance on Good Manufacturing Practices (GMP) for Active Pharmaceutical Ingredients (APIs) Guidelines (GUI-0104) & Consultation Template – see attached) www.jptcp.com/files/Health_Canada_email._GUI_0104.Oct.23.2012.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

Document: A document entitled, “Summary Basis of Reconsideration Decision (SBRD) Reconsideration of a Notice of Non-Compliance Withdrawal” is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/revision-final/drugs-med/sbrd_smdr_bio_2012-10-03-eng.php

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 2, No. 32 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-2-32
 

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
 

 

~~~~~

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
 

 

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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
 

 

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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
 

 

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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
 

 

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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
 

 

~~~~~

 

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
 

 

~~~~~

 

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
 

 

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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

 

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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

 

 

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Regulatory Notes Archive