Regulatory Notes

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
 

 

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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
 

 

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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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Cleaning_Validation_GUI_0028_EN.pdf

GUI_0074_E.pdf

NHPD_Workshop_e_mail.pdf

NDSAC_Final_Recommendations_e_mail.pdf

HEADS UP - November 21, 2011

Notices of Compliance- November 14-18, 2011

• Efracea (doxycycline monohydrate) was approved as an anti-rosacea on November 14, 2011.

News from Health Canada

Health Canada

Advisory: Health Canada is advising Canadians of its decision to suspend authorization of Avastin for use in the treatment of a certain type of breast cancer (metastatic breast cancer).
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_159-eng.php

Advisory: An unauthorized health product, “Stiff One Hard 169” is being voluntarily recalled from the Canadian market after Health Canada’s testing identified an undeclared prescription medication in the product (thiodimethylsildenafil, an undeclared substance similar to the prescription medication sildenafil). “Stiff One Hard 169” is being promoted as a dietary supplement and may pose serious risks to the health of Canadians.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_160-eng.php

Biologics, Radiopharmaceuticals & Genetic Therapies Directorate (BGTD)

Report: The Therapeutics Biologics, Radiopharmaceuticals & Genetic Therapies Directorate (BGTD) Drug Submission Performance Quarterly Report is available for the third quarter (July – September).
www.jptcp.com/files/bgtd_dpbtg_11_q2_eng.pdf

Therapeutic Products Directorate (TPD)

Health Care Professional Advisory

Avastin (bevacizumab): Health Canada has suspended approval of Avastin® (bevacizumab) for use in metastatic breast cancer.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/avastin_7_hpc-cps-eng.php

Information Sheet: A web information sheet has been published on drug shortages.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/announce-annonce/shortage-rupture-eng.php

Report: The Expert Advisory Panel on the use of Avastin in metastatic breast cancer has released its report.
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/activit/sci-consult/avastin/report-rapport-eng.php

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

Record of Decisions:  A Record of Decisions is available for the June 27, 2011 meeting between Health Canada and the Canadian Generic Pharmaceutical Association (CGPA).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/assoc/2011-06-27-eng.php

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

Summary Basis of Decision: A Summary Basis of Decision is available for Gilenya.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2011_gilenya_137516-eng.php

Guidance Document: Health Canada has released the guidance document: How to Complete the Application for a New Medical Device Licence.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/md_gd_licapp_im_ld_demhom-eng.php

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

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

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

Form: A new Class II Medical Device Licence amendment application form is available.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/md_licam_im_demmhom_cla2-eng.php

Report: The Therapeutics Product Directorate (TPD) Drug Submission Performance Quarterly Report is available for the third quarter (July – September).
www.jptcp.com/files/tpd_dpt_11_q2_eng.pdf

National Interest

Federal Government – Chemical Substances Challenge

Chemical Substances Challenge: A notice of intent to amend the Domestic Substances List for 1 substance in Batch 6 of the challenge is available.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-6/index-eng.php

Gazette I

Canadian Environmental Protection Act, 1999:  A notice of intent to amend the Domestic Substances List under subsection 87(3) of the Canadian Environmental Protection Act, 1999 to indicate that subsection 81(3) of that Act applies to Benzene, (chloromethyl) is available.
http://www.gazette.gc.ca/rp-pr/p1/2011/2011-11-26/html/notice-avis-eng.html#d109

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 1, No. 45 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-vol-1-no-45
 

 

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HEADS UP - November 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 - 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 - 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

 

~~~~~

 

tpd_dpt_11_q2_eng.pdf

bgtd_dpbtg_11_q2_eng.pdf

FAR011021_e544_e563_Motz.pdf

draft_ctdcta_ebauche_ctddec_eng.pdf

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 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 - 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 - 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 - 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 - 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
 

 

~~~~~

 

JPTCP_CSPT2011_e533_e543_Hutson.pdf

JPTCP_CSPT2011_e528_e532_Soldin.pdf

JPTCP_CSPT2011_e513_e515_Lalonde.pdf

JPTCP_CSPT2011__e506_e512_Knoppert.pdf

JPTCP_CSPT2011_e523_e527_Koren.pdf

JPTCP_CSPT2011_e516_e522_McGilveray.pdf

FAR011_027_Ed_e505_koren.pdf

FAR011024_e503_e504_church.pdf

FAR011026_e500_e502_macleod.pdf

Draft_GUI_0031_GMP_for_Medical_Gases.pdf

NHPD_email._Product_Monographs.9.16.2011.pdf

Marigold_and_isolates_lutein_and_zeaxanthin_2011_08_18.pdf

NHPD_Probiotics_email.9.14.2011.pdf

Consultant\'s_Final_Report_Enzymes.pdf

FINAL_Guidelines_Paper_9_12_11[1].doc

NHPD.Enzymes.9.14.2011.pdf

NHPD_Survey.9.8.2011.pdf

NHPD_email.Information_Sessions.8.30.2011.pdf

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 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 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 - 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 - 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 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 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 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
 

 

~~~~~

 

FAR011019_e494_e499_Clarren.pdf

FAR011009__e486_e493_Ott.pdf

FAR010016_e475_e485_Stade.pdf

FAR011023_e471_e474_Dickens.pdf

JPTCP_CSPTLecture_e455_e470_Ogilvie.pdf

FAR_011_018_Buxton_Book_Review_e454[1][1].pdf

FAR011007_e440__e453_NashKoren.pdf

FAR011008_e426_e439_moore.pdf

JPTCP11058_e407_e415_blackburn.pdf

FACE2011ABSTRACTS_e416_e425.pdf

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 - 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

 

~~~~~

 

NAPRA_Policy_for_NHP.pdf

HEADS UP -July 4, 2011

Notices of Compliance - June 27 – July 1, 2011

• No new NOCs were published this week.

News from Health Canada

Health Canada

Response to Carlin Jury Recommendations: Health Canada's response to the Carlin Jury Recommendations aimed at the department or directly relevant to its mandate is available.
http://www.hc-sc.gc.ca/ahc-asc/pubs/hpfb-dgpsa/inquest-enquete_carlin-eng.php

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

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-96-eng.php
(X-Hero - Male Enhancer)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-95-eng.php
(Slim Xtreme Herbal Slimming Capsules)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-94-eng.php
(Natural Vigra VIAGRA Tablets - Satibo Capsules)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-93-eng.php
([Hua Tuo Brand] Youzhi Baoying Dan - [Lee Sze] Texiao Houtong Wan - Prolonged Man Power Essence)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-92-eng.php
(Black Ant)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-91-eng.php
(Beline Capsules)

Health Advisory: Health Canada is advising Canadians that Procter & Gamble is conducting a voluntary recall of "Oral B Anti-Cavity Dental Rinse- Alcohol Free" (NPN 02129930) and "Oral-B Anti-Bacterial with Fluoride - Alcohol Free Daily Use Mouthrinse" (DIN 02130823).
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_97-eng.php

Health Advisory: Health Canada is reminding Canadians, particularly women of child-bearing age, of the risks to children whose mothers take a valproate drug, used to treat epilepsy, while pregnant.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_90-eng.php

Therapeutic Products Directorate (TPD)

Notice of Decision: A Notice of Decision is available for Brilinta.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/nd_ad_2011_brilinta_132218-eng.php

Newsletter: The Canadian Adverse Reaction Newsletter, Volume 21 - Issue 3 - July 2011 is available.
http://www.hc-sc.gc.ca/dhp-mps/medeff/bulletin/carn-bcei_v21n3-eng.php

Calculation Chart: A Medical Device Establishment Licence Fee Calculation Chart is available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/directives/calcul-chart_md-im-eng.php

Document: The document entitled, “Regulation of Health Products Advertising in Canada - Overview for Physicians”, is available.
http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/overview-apercu-eng.php

Document: The document entitled, “Health Products Advertising on Physician Web Sites - Questions and Answers”, is available.
http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/web-qa-qr-eng.php

Scientific Advisory Committee: The following information is available regarding the Scientific Advisory Committee on Metabolic and Endocrine Therapies.

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

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

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

Scientific Advisory Panel: The following information is available regarding the Scientific Advisory Panel on Bioequivalence Requirements for Gender-Specific Drug Products (GSDP).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-consult/gender-sexe/index-eng.php

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-consult/gender-sexe/sapgsdp_tor_gcsmss_att-eng.php
(Terms of Reference)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-consult/gender-sexe/sapgsdp_gcsmss_m_bio-eng.php
(Membership List)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-consult/gender-sexe/sapgsdp_a_gcsmss_o-eng.php
(June 2, 2011 Meeting – Agenda)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-consult/gender-sexe/sapgsdp_rop_gcsmss_crd_2011-06-02_ati-eng.php
(June 2, 2011 Meeting - Record of Proceedings)

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

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

Program Evaluation Request for Proposal: CADTH is seeking proposals from contractors to complete Phase I of a four-year program-wide outcomes evaluation.
http://www.cadth.ca/en/media-centre/ekos-evaluation

Patented Medicine Prices Review Board (PMPRB)

Board Order: The Hearing Panel published the board order and its decision on the merits in the matter of ratiopharm Inc.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=215

 

~~~~~

HEADS UP - July 11, 2011

Notices of Compliance - July 4 - 8, 2011

• Benlysta (belimumab) was approved as an immunosuppressant on
2011-07-06.

News from Health Canada

Health Canada

Health Advisory: Health Canada is informing health professionals and consumers that the labelling information for the drug metoclopramide is being updated to include stronger warnings on the risk of a movement disorder known as "tardive dyskinesia."
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_99-eng.php

Consultation: The Consumer and Clinical Radiation Protection Bureau of the Environmental and Radiation Health Sciences Directorate is conducting a national consultation of a new draft Safety Code on Mammography.
http://www.consultations.hc-sc.gc.ca/public-consult/consultations/calendar-calendrier/consultation_e.php?id=622

Biologics, Radiopharmaceuticals & Genetic Therapies Directorate (BGTD)

Summary Basis of Decision: A Summary Basis of Decision (SBD) is available for Cleviprex.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/sbd_smd_2011_cleviprex_125287-eng.php

Therapeutic Products Directorate (TPD)

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

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

Update on Program Evaluation Request Proposal: CADTH’s Program Evaluation Request Proposal has been updated. Questions submitted by potential bidders will be answered and posted publically to provide the opportunity for all bidders to review.
http://www.cadth.ca/en/media-centre/ekos-evaluation

Patented Medicine Prices Review Board (PMPRB)

Decision: The Federal Court of Canada released its decision in the Pentacel and Quadracel matters.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=216

National Association of Pharmacy Regulatory Authorities (NAPRA)

Consultation: A consultation has been opened regarding the draft updated NAPRA Policy for Natural Health Products.
www.jptcp.com/files/NAPRA_Policy_for_NHP.pdf

Meeting: The next meeting of the National Drug Scheduling Advisory Committee (NDSAC) is scheduled for September 11-12, 2011. http://napra.ca/pages/home/default.aspx?id=2953
 

 

~~~~~

 

HEADS UP - July 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
 

 

~~~~~

 

BGTD_DPBTG_11_Q1_ENG_1.pdf

TPD_DPT_11_Q1_ENG.pdf

For_Comments_template_e.doc

Risk_Classification_of_PMRC_Observations_GUI_0063_En_for_comments.pdf

PMRC_Guidelines_GUI_0102_en_for_comments.pdf

BGTD_DPBTG_11_Q1_ENG.pdf

Final_API_Stakeholders_Survey_2011_03_25_Eng_1.doc

NHPD_2010_2011_Q4_Report_Eng.pdf

NHPD_2010_2011_Q4_Report_Cover_letter.pdf

Annual_Package_2011_eng.pdf

Final_API_Stakeholders_Survey_2011_03_25_Eng.doc

HEADS UP - June 6, 2011

Notices of Compliance - May 30 – June 3, 2011

• Brilinta (ticagrelor) was approved as a platelet aggregation inhibitor on 2011-05-30.

News from Health Canada

Health Canada

Health Advisory: Health Canada is informing healthcare professionals and consumers that the prescribing information for the entire class of antipsychotic drugs is being updated. The updated labelling will contain safety information on the potential risk of abnormal muscle movements and withdrawal symptoms in newborns whose mothers were treated with these drugs during the third trimester of their pregnancy.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_78-eng.php

Unauthorized Health Products: A number of unauthorized health products, including sexual enhancement products, that may pose serious risks to the health of Canadians were removed from sale at Male and Female Harmony retail stores in Richmond and Burnaby, B.C., along with the Happy Paradise Adult Store in Burnaby.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_77-eng.php

Therapeutic Products Directorate (TPD)

Reminder: On March 25, 2011, Health Canada posted a Notice to Stakeholders on its web site inviting them to participate in the new Active Pharmaceutical Ingredients Survey (API) - Activities Conducted with Respect to Drugs for Human Use. This is a reminder to please complete the survey if you have not already done so.
www.jptcp.com/files/Final_API_Stakeholders_Survey_2011_03_25_Eng.doc

Annual Drug Notification Package: The Annual Drug Notification Package is available.
www.jptcp.com/files/Annual_Package_2011_eng.pdf

Consultation: The Draft Guidance Document: Guidance on supporting evidence to be provided for new and amended licence applications for Class III and Class IV medical devices, not including In Vitro Diagnostic Devices (IVDDs), is available for consultation.
http://www.hc-sc.gc.ca/dhp-mps/consultation/md-im/consult_md_draft_gd_data_im_ebauche_ld_donnees_ciii_civ-eng.php

Record of Proceedings: A Record of Proceedings is available for the March 29, 2011 meeting of the Scientific Advisory Panel on Opioid Analgesic Abuse.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-consult/opioid/sapoaa_rop_gcsaao_crd_2011-03-29-eng.php

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

Mutual Recognition Agreements Updates: Updates are available for Mutual Recognition Agreements.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/int/mra-arm/update-miseajour/index-eng.php

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 1, No. 24 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-vol-1-no-24

 

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HEADS UP - June 13, 2011

Notices of Compliance - June 6 - 10, 2011

• There were no new NOCs published this week.

News from Health Canada

Health Canada

Reports: The following Health Canada reports are available.

http://www.tbs-sct.gc.ca/rpp/2011-2012/index-eng.asp?acr=1772
(2011-2012 Report on Plans and Priorities)

http://www.hc-sc.gc.ca/ahc-asc/performance/estim-previs/plans-prior/2011-2012-tpp-ppt-eng.php
(Summary of Three-Year Plan for Transfer Payment Programs (2011-2014))

http://www.hc-sc.gc.ca/ahc-asc/performance/estim-previs/plans-prior/2011-2012-smr-drd-eng.php
(Future-oriented Financial Statements 2011-2012)

http://www.hc-sc.gc.ca/ahc-asc/activit/sus-dur/2011-2014-strateg-eng.php
(Planning for a Sustainable Future: Health Canada's 2011-2014 Sustainable Development Strategy)

Canada Consumer Product Safety Act: The Canada Consumer Product Safety Act came into force on June 20, 2011.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2011/2011_81-eng.php

Marihuana Medical Access Program: To reduce the risk of abuse and exploitation by criminal elements and keep our children and communities safe, the Honourable Leona Aglukkaq, Minister of Health, today announced that the Government of Canada is considering improvements to the Marihuana Medical Access Program.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2011/2011_80-eng.php

Health Advisory: Following an R.C.M.P. seizure of counterfeit Cialis in the Greater Toronto Area, Health Canada is reminding Canadians that unauthorized and counterfeit health products can pose serious risks to their health as they have not been reviewed by the Department for safety, quality, or efficacy.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_83-eng.php

Health Advisory: In light of studies suggesting an increased risk of bladder cancer with the diabetes drug pioglitazone, as well as actions taken by other regulatory agencies, Health Canada is informing healthcare professionals and Canadians that it is undertaking a review of the drug's status.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_79-eng.php

Biologics, Radiopharmaceuticals & Genetic Therapies Directorate (BGTD)

Membership List: The membership list of the Expert Advisory Committee on Blood Regulations (EAC-BR) is available.
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/activit/com/eacbr-ccers/memb-eng.php

Natural Health Products Directorate (NHPD)

Report: The NHPD Report, Status of Applications: Quarter 4 (January 1, 2011 to March 31, 2011) is available.
www.jptcp.com/files/NHPD_2010_2011_Q4_Report_Eng.pdf

Therapeutic Products Directorate (TPD)

Record of Decisions: A Record of Decisions is available for the March 23, 2011 meeting between Health Canada and Consumer Health Products Canada.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/assoc/2011-03-23-eng.php

Consultation: The purpose of this letter is to provide an opportunity to comment on the proposal to add to Part I of Schedule F to the Food and Drug Regulations six medicinal ingredients: amiodarone, its salts and derivatives; azacitidine, its salts and derivatives; certolizumab pegol; cladribine, its salts and derivatives; degarelix, its salts and derivatives; and urokinase.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult_project_projet_1659-eng.php

http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/project_projet_1659-eng.php
(Consultation Document)

Record of Discussions: A Record of Discussions is available for the April 19, 2011 meeting between the Canadian Advertising Preclearance Agencies and Health Canada.
http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/meet-reunion/rod-rdd_2011_04_19-eng.php

Document: The Health Canada document, “Health Canada's role in the Management and Prevention of Harmful Medication Incidents”, is available.
http://www.hc-sc.gc.ca/dhp-mps/medeff/cmirps-scdpim-eng.php

National Interest

Federal Government

Chemical Substances Challenge: On June 18, 2011, the updated draft screening assessment of substances of low concern using the rapid screening approach was published in the Canada Gazette, Part I.
http://www.chemicalsubstanceschimiques.gc.ca/plan/approach-approche/rapid-eng.php

Chemical Substances Challenge: The Risk Management Action Milestones table for Batch 3 substances has been published.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-3/risk-risque-eng.php

Chemical Substances Challenge: The Government of Canada published a Notice of intent to address a class of approximately 350 aromatic azo- and benzidine-based substances. The Notice of intent indicates that the Government of Canada plans to assess the potential health and ecological risks of these substances.
http://www.chemicalsubstanceschimiques.gc.ca/plan/approach-approche/azo_benzidine-eng.php

Gazette I

Canadian Environmental Protection Act, 1999: Publication after screening is available for the assessment of 545 substances specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999).
http://www.gazette.gc.ca/rp-pr/p1/2011/2011-06-18/html/index-eng.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 1, No. 25 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-vol-1-no-25

Patented Medicine Prices Review Board (PMPRB)

Annual Report: The PMPRB’s 2010 Annual Report was tabled before Parliament on June 16, 2011.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=213

Presentation: Michelle Boudreau, Executive Director, delivered a presentation at the Drug Pricing & Reimbursement in Canada conference in Toronto on June 14, 2011.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=212

Canadian Institutes of Health Research (CIHR)

Report: The report, Summary of Pharmaceutical Survey Findings on R&D Spending and Investments by Rx&D Members – 2010, is available.
http://www.cihr-irsc.gc.ca/e/43779.html

 

~~~~~

 

HEADS UP - June 20, 2011

Notices of Compliance - June 13 - 17, 2011

• Jevtana (cabazitaxel) was approved as an antineoplastic agent/taxane on 2011-06-16.

News from Health Canada

Health Canada

Statement: The Honourable Leona Aglukkaq, Minister of Health, issued a statement on Chronic Cerebrospinal Venous Insufficiency and Multiple Sclerosis.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2011/2011_87-eng.php

Health Advisory: Health Canada is informing Canadians of an ongoing review of the smoking-cessation aid Champix (the brand name for the prescription drug varenicline tartrate) and the possibility of a slightly increased risk of heart-related side effects in patients who have cardiovascular disease.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_84-eng.php

Biologics, Radiopharmaceuticals & Genetic Therapies Directorate (BGTD)

Membership List: The membership list for the Expert Advisory Committee on Cells, Tissues, and Organs is available.
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/activit/com/eaccto-ccecto/memb-eng.php

Natural Health Products Directorate (NHPD)

Report: The NHPD Status of Applications Quarterly Report: Quarter 4 (January 1, 2011 to March 31, 2011) is now available on the NHPD website.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/report-rapport/qar_tri_4-11-eng.php

Meeting: Notes are available for the March 28 and 29, 2011 meeting of the Natural Health Products Program Advisory Committee -Meeting #9.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/activit/com/program-28-03-2011-eng.php

Therapeutic Products Directorate (TPD)

Summary Basis of Decision: A Summary Basis of Decision (SBD) has been issued for Revolade.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/sbd_smd_2011_revolade_123984-eng.php

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

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 1, No. 26 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-vol-1-no-26

Patented Medicine Prices Review Board (PMPRB)

Compendium of Policies, Guidelines and Procedures: The Board released its annual updated version of the Compendium of Policies, Guidelines and Procedures for 2011 along with its Monitoring and Evaluation Plan for the Major Changes in the Guidelines.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=214

 

~~~~~

 

HEADS UP - June 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

 

 

~~~~~

 

tpd_dpt_10_q4_eng.pdf

tpd_dpt_annual_annuel_10_eng.pdf

bgtd_dpbtg_annual_annuel_10_eng.pdf

bgtd_dpbtg_10_q4_eng.pdf

HEADS UP - May 23, 2011

Notices of Compliance - May 16 - 20, 2011

• There were no new NOCs published this week.

On the Move

• The National Association of Pharmacy Regulatory Authorities (NAPRA) has a new President. David McLeod, a practicing pharmacist from Prince Edward Island, took over the role of President at the conclusion of the recent NAPRA Board of Directors meeting held on April 3, 2011.
http://napra.ca/Content_Files/Files/NR_New_NAPRA_President_English_June12011_Final.pdf

News from Health Canada

Biologics, Radiopharmaceuticals & Genetic Therapies Directorate (BGTD)

Report: The Biologics and Genetic Therapies Directorate Drug Submission Performance Annual Report: January – December 2010 is available.
www.jptcp.com/files/bgtd_dpbtg_annual_annuel_10_eng.pdf

Report: The Biologics and Genetic Therapies Directorate Drug Submission Performance Quarterly Report: October – December 2010 is available.
www.jptcp.com/files/bgtd_dpbtg_10_q4_eng.pdf

Therapeutic Products Directorate (TPD)

Meeting: A Meeting Summary Report is available for the October 20-21, 2010 meeting of the Expert Advisory Committee on the Vigilance of Health Products.
http://www.hc-sc.gc.ca/dhp-mps/medeff/eacvhp-ccvrps/meet-reunion/oct-oct-10-eng.php

Guidance: The new Guidance Document - Fees for the Right to Sell Drugs is available. This guidance document replaces the document, Authority to Sell Drug Fees, Fee Reductions and Adjustment Requests.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/fees-frais/right_sell_guid_droit_vendre-eng.php

Form: The Right to Sell Drugs Fee Remission Request and Attestation Form is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/form/right_sell_form_droit_vendre-eng.php

Report: The Therapeutic Products Directorate Drug Submission Performance Annual Report: January – December 2010 is available.
www.jptcp.com/files/tpd_dpt_annual_annuel_10_eng.pdf

Report: Therapeutic Products Directorate Drug Submission Performance Quarterly Report: October – December 2010 is available.
www.jptcp.com/files/tpd_dpt_10_q4_eng.pdf

Drug Submission Performance Reports: Information is available on Drug Submission Performance Reports.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/docs/perform-rendement/index-eng.php

Guidance: Health Canada is pleased to announce the release of the final version of the Guidance Document: Information to Be Provided by Manufacturers for the Reprocessing and Sterilization of Reusable Medical Devices.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/md_gd_reprocessing_im_ld_retraitement-eng.php

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

List of Registrars: The list of registrars recognized by Health Canada under section 32.1 of the Medical Devices Regulations (MDR) has been updated.
http://www.hc-sc.gc.ca/dhp-mps/md-im/qualsys/list_liste_regist-eng.php

Information Sessions: Health Canada is pleased to invite you to a one-day information session on the Medical Device Program (MDP) to take place across the country during the months of September and October, 2011.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/info-prod/md-im/md-im_session_ltr-eng.php

National Interest

Patented Medicine Prices Review Board (PMPRB)

Decision: The Hearing Panel published its decision on the merits in the matter of ratiopharm Inc. and the medicine ratio-Salbutamol HFA.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=211

Health Council of Canada (HCC)

Report: The Health Council of Canada has released the report entitled, “Progress Report 2011: Health care renewal in Canada”.
http://healthcouncilcanada.ca/en/index.php?page=shop.product_details&flypage=shop.flypage&product_id=137&category_id=16&manufacturer_id=0&option=com_virtuemart&Itemid=170

Canadian Generic Pharmaceutical Association (CGPA)

Report: The report entitled, “Innovation for A Better Tomorrow: A Critique”, is available.
http://www.canadiangenerics.ca/en/news/may_30_11.asp
 

 

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Notices of Compliance - May 23 - 27, 2011

• There were no new NOCs published this week.

News from Health Canada

Health Canada

Health Advisory: Health Canada is advising Canadians that Tanta Pharmaceuticals Inc. is conducting a voluntary recall of all lots of Junior Strength Acetaminophen Tablets 160 mg and Children's Strength Acetaminophen Tablets 80 mg.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_75-eng.php

Health Advisory: Health Canada is informing health professionals and consumers, particularly women, that it is conducting an ongoing safety review of drospirenone-containing oral contraceptives to evaluate the potential for an increased risk of venous thromboembolism (VTE, which are blood clots) relative to other birth control pills.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_74-eng.php

Health Advisory: Taro Pharmaceuticals Canada Inc., in consultation with Health Canada, is voluntarily recalling "Docusate Sodium Capsules USP, 100mg" (Lot # 31040225) from the Canadian market due to possible contamination with the bacterial organism cronobacter (enterobacter) sakazakii.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_73-eng.php

Biologics, Radiopharmaceuticals & Genetic Therapies Directorate (BGTD)

Record of Meeting: A Record of Meeting is available for the March 22, 2010 meeting of the Expert Advisory Committee on Blood Regulation.
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/activit/com/eacbr-ccers/_meet-reunion/mm-crr_2010-03-22-eng.php

Therapeutic Products Directorate (TPD)

Consumer Health Advisory

Rituxan: Hoffmann-La Roche Limited, in consultation with Health Canada, has informed health care professionals of important safety information regarding Rituxan® (rituximab) in Rheumatoid arthritis patients and severe infusion reactions.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2011/rituxan_6_pc-cp-eng.php

Health Care Professional Advisory

Rituxan: Hoffmann-La Roche Limited, in consultation with Health Canada, would like to inform you of important new safety information regarding fatal infusion related reactions following the use of Rituxan® (rituximab) in RA patients.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/rituxan_6_hpc-cps-eng.php

Medical Device Guidance: Health Canada is pleased to announce the release of the guidance document GD211: Guidance on the Content of Quality Management System Audit Reports.
http://www.hc-sc.gc.ca/dhp-mps/md-im/qualsys/cmdcas_scecim_audit13485_gd211-eng.php

Medical Device Guidance: A Guidance for the Interpretation of Significant Change of a Medical Device is available.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/signchng_modimportante-eng.php

Summary Basis of Decision: A Summary Basis of Decision (SBD) is available for Byetta.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/sbd_smd_2011_byetta_128932-eng.php

Record of Decisions: A Record of Decisions is available for the March 16, 2011 meeting between Health Canada and the Canadian Pharmacists Association.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/assoc/2011-03-16-eng.php

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 1, No. 23 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-vol-1-no-23

Newsletter: The CADTH Communiqué, Volume 1, No. 22 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-vol-1-no-22

Call for Public Members: The Canadian Agency for Drugs and Technologies in Health (CADTH) is accepting applications for the position of Public Member on its new Canadian Drug Expert Committee (CDEC) and health technology Expert Review Panel (for non-pharmaceuticals).
http://www.cadth.ca/en/media-centre/2011/call-for-public-members

 

 

~~~~~

 

HEADS UP - May 16, 2011

Notices of Compliance - May 9 - 13, 2011

• There were no new NOCs published this week.

News from Health Canada

Health Canada

Health Advisory: Following a release issued by the United States Food and Drug Administration (FDA), Health Canada and the Public Health Agency of Canada are advising parents, caregivers and healthcare providers not to feed "Simply Thick" to premature infants.
http://www.phac-aspc.gc.ca/alert-alerte/advisory-avis_20110520-eng.php

Information Sessions: Health Canada will be holding Information Sessions for Industry on changes to the Canada Consumer Product Safety Act, which come into force on June 20th, 2011.
http://surveys-sondages.hc-sc.gc.ca/s/ccpsa-infosession-lcspc-seanceinfo-eng/

Therapeutic Products Directorate (TPD)

Notice to Hospitals

Non-Sterile Boston Scientific Devices: Boston Scientific Corporation has issued an alert about a stolen shipment of Endoscopy and Urology / Women's Health medical devices. The labels on these devices state that they are "Sterile"; however, they were stolen prior to being sterilized and are non-sterile. Use of these non-sterile devices may lead to infection.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/device-dispositif_stolen-voles_nth-aah-eng.php

Notice of Decision: A Notice of Decision is available for Cleviprex.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/nd_ad_2011_cleviprex_125287-eng.php

Record of Decisions: A Record of Decisions is available for the February 23, 2011 meeting between Health Canada and Canada's Medical Device Technology Companies (MEDEC).
http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/meet-reunion/2011-02-23-eng.php

Record of Decisions: A Record of Decisions is available for the November 17, 2010 meeting between Health Canada and Canada's Medical Device Technology Companies (MEDEC).
http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/meet-reunion/2010-11-17-eng.php

Notice of Intent: The purpose of this Notice of Intent (NOI) is to provide an opportunity to comment on the revised proposal to amend Part I of Schedule F to the Food and Drug Regulations to add quinine, its salts and derivatives except in oral dosage form that provides 50 mg or less of quinine base per dosage unit or per daily dose.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult_project_projet_1431-eng.php

Notice: Health Canada is pleased to announce an increase in the types of submissions being accepted in the electronic-only filing format for a subset of eCTD submissions.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ctd/ectd/notice_scope_ectd_avis_augm-eng.php

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

Nominations: The deadline has been extended for the Canadian Drug Expert Committee (CDEC) Call for Nominations.
http://www.cadth.ca/en/media-centre/2011/5/18/deadline-extended-canadian-drug-expert-committee-cdec

Nominations: The deadline has been extended for the CADTH Expert Review Panel Call for Nominations.
http://www.cadth.ca/en/media-centre/2011/5/18/deadline-extended-cadth-expert-review-panel-call-for

Website: The Canadian Agency for Drugs and Technologies in Health has unveiled a new website.
http://www.cadth.ca/en/media-centre/2011/5/24/cadth-launches-new-website

 

~~~~~

 

HEADS UP - April 25, 2011

Notices of Compliance - April 18 - 22, 2011

• There were no new NOCs published this week.

On The Move

• The Minister of Health recently announced the appointments of Mary Catherine Lindberg as Chairperson of the Patented Medicine Prices Review Board and Dr. Mitchell Levine as Vice-Chairperson.

http://www.pmprb-cepmb.gc.ca/english/view.asp?x=1437&mid=1308

• Advertising Standards Canada has announced its 2011/2012 Board of Directors.

http://www.adstandards.com/en/MediaAndEvents/2011BoardOfDirectorsPressRelease.aspx

News from Health Canada

Health Canada

Health Advisory: Omega Alpha Pharmaceuticals Inc., in consultation with Health Canada, is voluntarily recalling all lots of "Omega Alpha Kidney Flush" due to the omission of cautionary and warning statements on the product label.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_63-eng.php

Health Advisory: A list of recalled Health Products manufactured by the Triad Group is available.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_61pl-eng.php

Therapeutic Products Directorate (TPD)

Consumer Health Advisory

Anzemet: New data show that the injectable form of Anzemet® can potentially increase the risk of abnormal heart rhythm which may result in serious cardiac problems at the doses recommended for the prevention of nausea and vomiting.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2011/anzemet_pc-cp-eng.php

Health Care Professional Advisory

Anzemet: Sanofi-aventis Canada Inc., in collaboration with Health Canada, would like to inform you of the withdrawal of Anzemet® (dolasetron mesylate) intravenous injection as it is no longer indicated to prevent nausea and vomiting in adults undergoing chemotherapy.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/anzemet_hpc-cps-eng.php

MedEffect Canada Initiative: Information is available on the MedEffect Canada Initiative, the Public Interface to Post-Market Surveillance Programs and Information.
http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_fs-if/2011-medeff-canada/index-eng.php

Document: The Health Canada document entitled, “Canada Vigilance Program - Collecting and Assessing Adverse Reaction Reports”, is available.
http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_fs-if/2011-cvp-pcv/index-eng.php

Document: The Health Canada document entitled, “Risk Communication - Protecting Canadians through Information”, is available.
http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_fs-if/2011-risk_comm_risque/index-eng.php

Document: The Health Canada document entitled, “The Canadian Adverse Reaction Newsletter - Keeping Health Professionals Informed”, is available.
http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_fs-if/2011-carn-bcei/index-eng.php

Document: The Health Canada document entitled, “Regulating Advertising of Health Products”, is available.
http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_fs-if/2011-advert-publicite/index-eng.php

Expert Advisory Committee on the Vigilance of Health Products: Information is available on the Expert Advisory Committee on the Vigilance of Health Products.
http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_fs-if/2011-eac-vhp-cce-vps/index-eng.php

Summary Basis of Decision: A Summary Basis of Decision (SBD) was issued for Nucynta CR.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/sbd_smd_2011_nucynta_cr_133167-eng.php

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 1, No. 18 is available and contains a Common Drug Review Update.
http://www.cadth.ca/index.php/en/cadth/products/cadth-communique-home/cadth-communique-vol-1-no-18

Newsletter: The May 4, 2011 issue of the Common Drug Review Update — Issue 75 is available. A Pilot Process for Filing Pre-submission Information and changes to CDR Submission Guidelines for Manufacturers are among the topics discussed.
http://www.cadth.ca/index.php/en/cdr/cdr-update/cdr-update-issue-75

Reports: The following reports are available.

http://www.cadth.ca/media/pdf/htis/april-2011/RA0521_PreOp_Markings_Final.pdf
(Pre-Operative Surgical Site Markings for Elective Surgical Patients: Guidelines)

http://www.cadth.ca/media/pdf/htis/april-2011/RA0523_Cochlear_Implant_Upgrades_Final.pdf
(Speech Processor Upgrades in Pediatric Patients with Cochlear Implants: Clinical Evidence and Guidelines)

http://www.cadth.ca/media/pdf/htis/april-2011/L_0258_Technegas_Final.pdf
(Ventilation/Perfusion scintigraphy (using Technegas) versus Computed Tomography Pulmonary Angiography for the Diagnosis of Pulmonary Embolism in Hospitalized Patients: A Review of the Clinical and Cost-Effectiveness)

http://www.cadth.ca/media/pdf/htis/april-2011/RB0355_Patient_Transport_from_Tertiary_Care_Final.pdf
(Patient Transport from Tertiary Care: Guidelines and Recommendations)

http://www.cadth.ca/media/pdf/htis/april-2011/L0259_MALDI-TOF_Final.pdf
(MALDI-TOF Mass Spectrometry for Bacterial Species Identification: A Review of Diagnostic Accuracy and Clinical and Cost-Effectiveness)

http://www.cadth.ca/media/pdf/htis/april-2011/RC0275_Makoplasty_Final.pdf
(MAKO’s RESTORIS Implants and MAKOplasty Procedure for Early to Mid-Stage Osteoarthritic Knee Disease: A Review of the Clinical and Cost-Effectiveness and Safety)

http://www.cadth.ca/media/pdf/htis/april-2011/RB0353_Alternate_Level_of_Care_Units_Final.pdf
(Alternate Level of Care Units in Medical and Surgical Acute Care Facilities: Clinical Evidence and Guidelines)

http://www.cadth.ca/index.php/en/hta/reports-publications/environmental-scans/environmental-scans-20
(Issue 20 - An Update on the Investigation of Chronic Cerebrospinal Venous Insufficiency for the Treatment of Multiple Sclerosis)

Patented Medicine Prices Review Board (PMPRB)

Newsletter: The PMPRB has released its April 2011 NEWSletter.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=207

 

~~~~~

 

HEADS UP - April 18, 2011

Notices of Compliance - April 11 - 15, 2011

• Cleviprex (clevidipine) was approved as an antihypertensive agent on 2011-04-15.

On the Move

• Dr. Brian O’Rourke has been appointed President and Chief Executive Officer of the Canadian Agency for Drugs and Technologies in Health, effective April 1, 2011.
http://www.cadth.ca/index.php/en/media-centre/2011/04/21/249

News from Health Canada

Health Canada

Health Advisory: Following potential bacterial contamination or inadequate sterilization of products in the United States, the Triad Group, including their Canadian importers and distributors, have voluntarily initiated a series of recalls of a number of products used by consumers throughout North America.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_61-eng.php

Biologics, Radiopharmaceuticals & Genetic Therapies Directorate (BRGD)

Food and Drug Regulations: Regulations amending the Food and Drug Regulations (1319 - New Drugs for Extraordinary Use) are available.
http://canadagazette.gc.ca/rp-pr/p2/2011/2011-04-13/html/sor-dors88-eng.html

Patented Medicines Regulations: Regulations amending the Patented Medicines (Notice of Compliance) Regulations are available.
http://canadagazette.gc.ca/rp-pr/p2/2011/2011-04-13/html/sor-dors89-eng.html

Therapeutic Products Directorate (TPD)

Notice: Health Canada has released a notice regarding the interim approach for evaluating cardiovascular risk for new antidiabetic therapies to treat Type 2 Diabetes Mellitus.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/notice_diabet_avis-eng.php

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué — Volume 1, No. 17 is available.
http://www.cadth.ca/index.php/en/cadth/products/cadth-communique-home/cadth-communique-vol-1-no-17

Environmental Scan: The Environmental Scan entitled, “Issue 18 - Drug Supply Disruptions”, is available.
http://www.cadth.ca/index.php/en/hta/reports-publications/environmental-scans/environmental-scans-18

Environmental Scan: The Environmental Scan entitled, “Issue 19 - Funding of Laboratory Testing in Canada”, is available.
http://www.cadth.ca/index.php/en/hta/reports-publications/environmental-scans/environmental-scans-19

National Association of Pharmacy Regulatory Authorities (NAPRA)

Meeting: The proposed meeting of the National Drug Scheduling Advisory Committee for June 12-13, 2011 is cancelled. The next meeting of the Committee is scheduled for September 11-12, 2011. The deadline to receive submissions for a drug scheduling application for this meeting is by end of day Wednesday, July 13, 2011.
http://napra.ca/pages/home/default.aspx

Final Recommendation: The Initial Recommendation made by the National Drug Scheduling Advisory Committee (NDSAC) on March 6, 2011 for the scheduling of:

-Naproxen sodium 220 mg per oral dosage unit (when sold in products labelled with a recommended maximum daily dose of 440 mg, and in package sizes exceeding 6,600 mg) - Schedule III (from Schedule II)

was finalized effective April 21, 2011. Final approval of the Initial Recommendation was made by NAPRA's Executive Committee, in consideration of comments received during the 30-day review period. The National Drug Schedules will be revised accordingly.
http://napra.ca/pages/home/default.aspx?id=2923

~~~~~

 

HEADS UP - May 2, 2011

Notices of Compliance - April 25 - 29, 2011

• There were no new NOCs published this week.

News from Health Canada

Health Canada

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

http://hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-67-eng.php
(Rock Hard Extreme - Passion Coffee)

http://hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-66-eng.php
(JianBu HuQian Wan)

http://hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-65-eng.php
(Gold Seagull Long Zhi Wan – Venergy)

http://hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-64-eng.php
(Dr. Health Series CM Factor)

Biologics, Radiopharmaceuticals & Genetic Therapies Directorate (BRGD)

Draft Regulations: Health Canada is pleased to announce that the draft Blood Regulations are anticipated to be published in Canada Gazette Part I (CGI) in 2011. The stand-alone Blood Regulations -- under the authority of the Food and Drugs Act -- will contain safety, quality and efficacy requirements with respect to blood for transfusion or for further manufacture.
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/reg-init/blood-sang/blood_notice-sang_avis-eng.php

Therapeutic Products Directorate (TPD)

Health Care Professional Advisory

Cytarabine Injection: Hospira is bringing to your attention the potential for Cytarabine crystallization in certain lots of Cytarabine Injection (DIN: 02126656); 2 g/ 20 mL (100 mg/mL) product currently on the Canadian market.
http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/cytarabine_hpc-cps-eng.php

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

National Interest

Advertising Standards Canada (ASC)

Workshop: Advertising Standards Canada will be holding a Clearance Services Workshop entitled, “Demystifying the Requirements for Direct-to-Consumer Advertising of Prescription Drugs (DTCA Rx) and Direct-to-Consumer Information (DTCI)”.

http://www.adstandards.com/en/Events/201105DrugsToronto.asp
(Toronto)

http://www.adstandards.com/en/Events/201106DrugsMontreal.asp
(Montreal)

Canadian Intellectual Property Office (CIPO)

2011-2012 Business Plan: CIPO's 2011-2012 Business Plan outlines the progress CIPO intends to make in the final year of the five-year Strategic Plan, Moving Forward to Canada's Advantage, and sets the stage for launching the next five-year Strategic Plan. http://www.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr03060.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: CADTH Communiqué, Volume 1, No. 19 is available.
http://www.cadth.ca/index.php/en/cadth/products/cadth-communique-home/cadth-communique-vol-1-no-19

Expert Review Panel: CADTH is accepting nominations of Core Members, including a Chair, for its new Expert Review Panel.
http://www.cadth.ca/index.php/en/media-centre/2011/05/5/250

Canadian Drug Expert Committee (CDEC): CADTH is accepting nominations for Core Members and a Chair for its new drug expert committee.
http://www.cadth.ca/index.php/en/media-centre/2011/05/5/252

Announcement: The Canadian Agency for Drugs and Technologies in Health (CADTH) is pleased to announce its priority areas for 2011-2012.
http://www.cadth.ca/index.php/en/media-centre/2011/05/6/253

Reports: The following reports are available.

http://www.cadth.ca/media/pdf/htis/may-2011/RC0265_Methotrexate_for_Rheumatoid_Arthritis_final.pdf
(Methotrexate for the Treatment of Rheumatoid Arthritis: A Review of the Clinical Evidence)

http://www.cadth.ca/media/pdf/htis/may-2011/RCO268_safety_of_leflunomide_and_methotrexate_Final.pdf
(Safety of Leflunomide and Methotrexate as Combination Therapy for Rheumatoid Arthritis: A Review of the Clinical Evidence)

http://www.cadth.ca/media/pdf/htis/may-2011/RC0264%20-%20Short-acting%20spinal%20anesthetics%20final.pdf
(Short-Acting Spinal Anesthetics for Outpatient Procedures: A Review of the Clinical Evidence and Guidelines)

http://www.cadth.ca/media/pdf/htis/april-2011/RB0353_Alternate_Level_of_Care_Units_Final.pdf
(Alternate Level of Care Units in Medical and Surgical Acute Care Facilities: Clinical Evidence and Guidelines)

http://www.cadth.ca/media/pdf/htis/may-2011/RC0262_Central_Monitors_in_Small_Hospitals_Final.pdf
(Central Monitors for Acutely-Ill Cardiac Patients in a Small, Rural Hospital Setting: A Review of Clinical and Cost-Effectiveness)

http://www.cadth.ca/media/pdf/htis/may-2011/RC0261-000_-_CADDRA_Guidelines_on_ADHD_Final.pdf
(Quality Assessment of the Canadian Attention Deficit Hyperactivity Disorder Resource Alliance ADHD Practice Guidelines for Children, Adolescents and Adults with ADHD)

http://www.cadth.ca/media/pdf/htis/may-2011/RB0352_Zopiclone_Final.pdf
(Safety of Zopiclone for Insomnia: Comparative Safety)

http://www.cadth.ca/media/pdf/htis/may-2011/RB0354_EpinephrineDosing_Final.pdf
(Higher than Recommended Doses of Epinephrine for Patients with an Allergic Reaction: Clinical Evidence and Safety)

http://www.cadth.ca/media/pdf/htis/may-2011/RA0522_Electronic_Beds_for_Pediatric_Patients_Final.pdf
(Electronic Beds for Pediatric Patients: Safety)

http://www.cadth.ca/media/pdf/htis/may-2011/RC0267_Best_Practice_Tools_Final.pdf
(Screening and Assessment Tools for Patients with Chronic Disease in Therapeutic Exercise Program: A Review of the Clinical Evidence and Guidelines)

Canadian Institute for Health Information (CIHI)

Report: The CIHI has released the report entitled, “Drug Expenditure in Canada, 1985 to 2010”.
http://secure.cihi.ca/cihiweb/products/drug_expenditure_2010_en.pdf
 

 

~~~~~

 

HEADS UP - May 9, 2011

Notices of Compliance - May 2 – 6, 2011

• There were no new NOCs published this week.

News from Health Canada

Biologics, Radiopharmaceuticals & Genetic Therapies Directorate (BGTD)

Meeting: A Record of Decisions is available for the December 15, 2010 meeting between the Nuclear Medicine Alliance and Health Canada.
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/activit/meet-reunion/nma-mm-crr-2010-12-15-eng.php

 Meeting: Minutes are available for the March 25, 2011 meeting between Health Canada and BIOTECanada.
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/activit/meet-reunion/biotecanada-mm-crr-2011-03-25-eng.php

Therapeutic Products Directorate (TPD)

Electronic Submissions Reminder: Health Canada would like to remind sponsors not to include credit card, wire, or cheque payment information within electronic submissions.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/announce-annonce/notice_finance_avis-eng.php

Record of Decisions: A Record of Decisions is available for the February 16, 2011 meeting between Health Canada and the Canadian Cosmetic, Toiletry and Fragrance Association (CCTFA).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/assoc/2011-02-16-eng.php

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

Summary Basis of Decision: A Summary Basis of Decision (SBD) is available for Rapaflo.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/sbd_smd_2011_rapaflo_121740-eng.php

National Interest

Advertising Standards Canada (ASC)

Newsletter: The Spring 2011 issue of enews is available.
http://adstandards.com/en/ASCLibrary/newsletters/spring2011/newsletter_ASCNews.aspx

Canadian Intellectual Property Office (CIPO)

Memorandum of Understanding: CIPO and the Instituto Nacional da PI (INPI) from Brazil signed a Memorandum of Understanding.
http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr03026.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: CADTH Communiqué, Volume 1, No. 21 is available.
http://www.cadth.ca/index.php/en/cadth/products/cadth-communique-home/cadth-communique-vol-1-no-21

Newsletter: CADTH Communiqué, Volume 1, No. 20 is available.
http://www.cadth.ca/index.php/en/cadth/products/cadth-communique-home/cadth-communique-vol-1-no-20

Report/Guidance: The final report and guidance document for the 1.5 Tesla Magnetic Resonance Imaging Scanners Compared with 3.0 Tesla Magnetic Imagining Scanners pilot project have been released.
http://www.cadth.ca/index.php/en/media-centre/2011/05/17/254

Reports: The following reports are available.

http://www.cadth.ca/media/pdf/htis/may-2011/RA0524_BoneMarrowTesting_Final.pdf
(Bone Marrow Testing for Acute and Chronic Leukemias and Lymphomas: Guidelines)

http://www.cadth.ca/media/pdf/htis/may-2011/RB0351_Vasopressors_in_Free_Flap_Surgery_Final.pdf
(Vasopressors in Free Flap Surgery: Clinical Benefits and Harms)

http://www.cadth.ca/media/pdf/htis/may-2011/RB0358_Aerosolized_Bronchodilator_Administration_Final.pdf
(Aerosolized Bronchodilator Administration: Guidelines)

http://www.cadth.ca/media/pdf/htis/may-2011/RA0520_IV_Fluid_Infusion_Final.pdf
(Intravenous Fluid and Medication Administration Infusion in Pediatric Patients: Guidelines)

http://www.cadth.ca/media/pdf/htis/may-2011/RB0366_Guanfacine_for_Hyperactivity_Final.pdf
(Guanfacine for the Treatment of Attention Deficit Hyperactivity Disorder in Pediatric Patients: Clinical Effectiveness)

http://www.cadth.ca/media/pdf/htis/may-2011/RB0359_Surgical_Referrals_Final.pdf
(Surgical Referral and Appropriateness of Surgery: Clinical Evidence, Best Practices and Guidelines)

Patented Medicine Prices Review Board (PMPRB)

Hearings: The Board is seeking comments on its proposed revised Rules of Practice and Procedure for its hearings by June 30, 2011.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=210

http://www.pmprb-cepmb.gc.ca/cmfiles/consultations/NC-Cons-RevRules-may2011-e.pdf
(Revised Rules of Practice and Procedure for Board Hearings)

Voluntary Compliance Undertaking: The Chairperson of the Board accepted a Voluntary Compliance Undertaking (VCU) for Technescan MAG3.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=209

Voluntary Compliance Undertaking: The Chairperson of the Board accepted a Voluntary Compliance Undertaking (VCU) for Niaspan.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=208
 

 

~~~~~

 

HEADS UP - March 21, 2011

Notices of Compliance - March 14 - 18, 2011

• There were no new NOCs published this week.

On the Move

• Barb Shea, Vice-President of Products and Services, will be leaving the Canadian Agency for Drugs and Technologies in Health (CADTH) and full-time employment on March 31, 2011.
http://www.cadth.ca/index.php/en/cadth/corporate-profile/executive-news

News from Health Canada

Health Canada

Announcement: The Honourable Leona Aglukkaq, Minister of Health, and the Honourable Rona Ambrose, Minister for Public Works and Government Services and Minister for Status of Women, announced that after an open, fair and transparent bidding process the Government of Canada awarded contracts for the supply of the influenza vaccine for seasonal immunization programs and for use in the case of a pandemic.
http://www.phac-aspc.gc.ca/media/nr-rp/2011/2011_0325-2-eng.php

Document: Health Canada has released the document, ‘It's Your Health - Salvia divinorum’.
http://www.hc-sc.gc.ca/hl-vs/iyh-vsv/life-vie/salvia-eng.php

Biologics, Radiopharmaceuticals & Genetic Therapies Directorate (BRGD)

PSURs/AEFIs: Health Canada's Health Products and Food Branch (HPFB) is informing vaccine market authorization holders (MAH) of its intent to change the reporting process for AEFIs and PSURs for prophylactic vaccines.
http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/notice-avis_vacc-eng.php

Meeting Minutes: Meeting Minutes are available for the May 25, 2010 meeting between Health Canada and BIOTECanada.
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/activit/meet-reunion/biotecanada-mm-crr-2010-05-25-eng.php

Therapeutic Products Directorate (TPD)

Notice to Hospitals

Plum A+ Infusion Pumps Update:  An update to the recall of Plum A+ Infusion Pumps is available.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/plum_infusion_2_nth-aah-eng.php

Plum A+ Infusion Pumps:  Plum A+ Infusion Pumps have been recalled due to audible alarm failure.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/plum_infusion_nth-aah-eng.php

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

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

Consultation: Health Canada invites you to participate in the nation-wide "Active Pharmaceutical Ingredients Survey - Activities Conducted with Respect to Drugs for Human Use".
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/docs/api-ipa_survey-ltr-eng.php

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

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

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

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

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

Q & A: Questions and Answers are available regarding Private Label Medical Devices.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/qalabel_qrmarque_priv-eng.php

Guidance: The Guidance Document: How to Complete the Application for a New Medical Device Licence/Medical Device Licence Amendment for a Private Label Medical Device is available.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/applabel_demmarque_priv-eng.php

Guidance: The Guidance Document - Private Label Medical Devices is available.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/label_marque_pri-eng.php

Form: The Form - Application for a New Medical Device Licence for a Private Label Medical Device is available.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/licapp_demhom_label_marque_npriv-eng.php

Guidance: The Guidance Document - How to Complete the Application for a New Medical Device Licence is available.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/md_gd_licapp_im_ld_demhom-eng.php

Guidance: A  Guidance is available on the Investigation of Reported Medical Device Problems (GUI-0065).
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/prob-report-rapport/gui-0065_md-im_problem_doc-eng.php

Guide: A Guide is available to Recalls of Medical Devices (GUI-0054).
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/prob-report-rapport/gui-0054_recall-retrait-doc-eng.php

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

Guidance: The Guidance Document - Management of Drug Submissions is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/mgmt-gest/mands_gespd-eng.php

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

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

Fees: New regulations will come into effect on April 1, 2011 regarding fees in respect of Human Drugs and Medical Devices.
http://www.hc-sc.gc.ca/dhp-mps/finance/fees-frais/index-eng.php

National Interest

Gazette I

Food And Drug Regulations: A Notice of Intent has been issued to provide an opportunity for comment on the revised proposal to amend Part I of Schedule F to the Food and Drug Regulations to add quinine, its salts and derivatives except in oral dosage form that provides 50 mg or less of quinine base per dosage unit or per daily dose.
http://www.gazette.gc.ca/rp-pr/p1/2011/2011-03-26/html/index-eng.html

Canadian Intellectual Property Office (CIPO)

Patent Rule: Notice is given that the Governor in Council has approved the Proposed Amendments to the Patent Rules – Expedited Examination of Patent Applications Related to Green Technology. The Rules Amending the Patent Rules came into force on March 3, 2011.
http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr02995.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Consultation: Two draft reports for the pilot project 1.5 Tesla Magnetic Resonance Imaging Scanners compared with 3.0 Tesla Magnetic Resonance Imaging Scanners are available for feedback from all interested stakeholders.
http://www.cadth.ca/index.php/en/media-centre/2011/03/24/246

New Articles: New articles have been released that call on Health Professionals to consider current evidence when recommending self-monitoring of blood glucose.
http://www.cadth.ca/index.php/en/media-centre/2011/03/28/247

Newsletter: The CADTH Communiqué — Volume 1, No. 14 is available.
http://www.cadth.ca/index.php/en/cadth/products/cadth-communique-home/cadth-communique-vol-1-no-14

Newsletter: The CADTH Communiqué — Volume 1, No. 13 is available.
http://www.cadth.ca/index.php/en/cadth/products/cadth-communique-home/cadth-communique-vol-1-no-13

Patented Medicine Prices Review Board (PMPRB)

Voluntary Compliance Undertaking: The Chairperson of the Board accepted a Voluntary Compliance Undertaking (VCU) for Abilify.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=205

Report: The final Report of the DIP Methodology Technical Working Group on the implementation of the Methodology is available.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=204

 

~~~~~

 

HEADS UP - March 28, 2011

Notices of Compliance - March 21 - 25, 2011

• There were no new NOCs published this week.

News from Health Canada

Health Canada

Health Advisory: Following a previous communications regarding Probiotic Natural Health Products, Health Canada is updating Canadians on two additional probiotic natural health products found on the Canadian market that are labelled as vegan or not containing dairy (milk) but that may contain trace amounts of milk from ingredients used in the production process.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_53-eng.php

HPFB Inspectorate

Notice: A Notice has been issued regarding important upcoming changes to Establishment Licensing.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/notice-avis_ltr-eng.php

Therapeutic Products Directorate (TPD)

Notice to Hospitals

Bertec Model FLH668NDCM Medical Beds: There has been a recall of Bertec Model FLH668NDCM Medical Beds due to the potential for the head or foot section to drop unexpectedly.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/bertec_beds-lits_nth-aah-eng.php

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

National Interest

Advertising Standards Canada (ASC)

Report: Advertising Standards Canada (ASC) has released its Ad Complaints Report - 2010 Year in Review.
http://www.adstandards.com/en/MediaAndEvents/2010complaintsReportPressRelease.aspx

Canadian Agency for Drugs and Technologies in Health (CADTH)

Reports: The following reports are available.

http://www.cadth.ca/media/pdf/htis/april-2011/J0517_Nursing_Hours_per_Patient_Day_Final.pdf
(Nursing Hours per Patient Day for Paediatric and Maternal Health: Guidelines)

http://www.cadth.ca/media/pdf/htis/april-2011/RA0519_White_Boards_in_the_OR_final.pdf
(White Boards for Transcription of Surgical Counts in the Operating Room: Clinical Effectiveness, Benefits and Harms to Operating Room Patients)

http://www.cadth.ca/media/pdf/htis/april-2011/K0339__Leveliracetam_Treatment_for_Epilepsy_final.pdf
(Levetiracetam Treatment in Patients with Epilepsy: Clinical and Cost-Effectiveness and Safety)

http://www.cadth.ca/media/pdf/htis/march-2011/K0342_Quetiapine_for_Affective_and_PSD_and_BPD_final.pdf
(Quetiapine for Affective and Psychotic Spectrum Disorders and Borderline Personality Disorder: Clinical Effectiveness)

http://www.cadth.ca/media/pdf/htis/march-2011/K0337_Social_Interactions_in_RCF_final.pdf
(Appropriate Social Interactions for Patients in Residential Care Facilities: Guidelines)

http://www.cadth.ca/media/pdf/htis/march-2011/L0252_Audio_screening_final.pdf
(Auditory Screening and Hearing Loss Prevention: Clinical Effectiveness and Guidelines)

http://www.cadth.ca/media/pdf/htis/march-2011/J0515_Heparin_Prophylaxis_final.pdf
(Heparin Prophylaxis for Hospitalized Patients at Risk for Thrombotic Events: Clinical Effectiveness and Safety)

http://www.cadth.ca/media/pdf/htis/march-2011/L0254_Nonstress_Testing_final.pdf
(Non-Stress Testing for Pregnant Adult Diabetics)

http://www.cadth.ca/media/pdf/htis/march-2011/K0336_Rituximab_final.pdf
(Rituximab for the Treatment of Autoimmune Hemolytic Anemia: Clinical Evidence and Guidelines)

http://www.cadth.ca/media/pdf/htis/march-2011/K0335_Aquadex_Flexflow_for_CHF_final.pdf
(Aquadex Flexflow for Patients with Congestive Heart Failure: Clinical and Cost-Effectiveness)

http://www.cadth.ca/index.php/en/hta/reports-publications/environmental-scans/issue-17
(Issue 17: Initiatives for Healthy Aging in Canada)

http://www.cadth.ca/media/pdf/htis/april-2011/K0338_Guidelines_for_Treatment_of_Epilepsy_final.pdf
(Pharmacological Treatments in Patients with Epilepsy: Guidelines)
 

 

~~~~~

 

HEADS UP - April 4, 2011

Notices of Compliance - March 28 – April 1, 2011

• There were no new NOCs published this week.

News from Health Canada

Health Canada

Health Advisory: "U-Prosta Natural support for prostate health" is being voluntarily recalled in Canada by Sunnylife International Inc. after the U.S. Food and Drug Administration (FDA) found the product contains undeclared terazosin hydrochloride, which is a prescription drug used to treat high blood pressure and enlargement of the prostate gland, and could cause serious health effects.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_54-eng.php

Therapeutic Products Directorate (TPD)

Notice to Hospitals

Rusch Irrigation Trays: A recall has been issued for Rusch Irrigation Trays due to the potential contamination of alcohol prep pads co-packaged with RUSCH Irrigation Tray with Piston Catalogue Number 67890 and RUSCH Irrigation Tray with Bulb Catalogue Number 68895.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/rusch_irrigation_tray-plateau_nth-aah-eng.php

National Interest

Gazette II

Financial Administration Act: Regulations amending the Authority to Sell Drugs Fees Regulations are available.
http://www.gazette.gc.ca/rp-pr/p2/2011/2011-04-13/html/sor-dors80-eng.html

Financial Administration Act: Regulations amending the Establishment Licensing Fees Regulations (1056) are available.
http://www.gazette.gc.ca/rp-pr/p2/2011/2011-04-13/html/sor-dors84-eng.html

Financial Administration Act: Fees in respect of Drugs and Medical Devices Regulations are available.
http://www.gazette.gc.ca/rp-pr/p2/2011/2011-04-13/html/sor-dors79-eng.html

Food and Drugs Act: Regulations amending the Food and Drug Regulations are available.
http://www.gazette.gc.ca/rp-pr/p2/2011/2011-04-13/html/sor-dors81-eng.html

Food and Drugs Act: Regulations amending the Food and Drug Regulations (1319 — New Drugs for Extraordinary Use) are available.
http://www.gazette.gc.ca/rp-pr/p2/2011/2011-04-13/html/sor-dors88-eng.html

Food and Drugs Act: Regulations amending the Food and Drug Regulations (1624 — Schedule F) are available.
http://www.gazette.gc.ca/rp-pr/p2/2011/2011-04-13/html/sor-dors93-eng.html

Financial Administration Act: Regulations amending the Licensed Dealers for Controlled Drugs and Narcotics Fees Regulations (1056) are available.
http://www.gazette.gc.ca/rp-pr/p2/2011/2011-04-13/html/sor-dors83-eng.html

Food and Drugs Act: Regulations amending the Medical Devices Regulations are available.
http://www.gazette.gc.ca/rp-pr/p2/2011/2011-04-13/html/sor-dors82-eng.html

Patent Act: Regulations amending the Patented Medicines (Notice of Compliance) Regulations are available.
http://www.gazette.gc.ca/rp-pr/p2/2011/2011-04-13/html/sor-dors89-eng.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué — Volume 1, No. 15 is available.
http://www.cadth.ca/index.php/en/cadth/products/cadth-communique-home/cadth-communique-vol-1-no-15

Reports: The following reports are available.

http://www.cadth.ca/media/pdf/htis/april-2011/J0518%20VTE%20Prophylaxis%20final.pdf
(Venous Thromboembolism Prophylaxis: Clinical Evidence and Guidelines)

http://www.cadth.ca/media/pdf/htis/april-2011/K0340_COPD_Management_in_the_ED_final.pdf
(Clinical Management of Chronic Obstructive Pulmonary Disease in the Emergency Department: Guidelines)

http://www.cadth.ca/media/pdf/htis/april-2011/L0255_Umbilical_Cord_Clamp_Removal_final.pdf
(Umbilical Cord Clamp Removal: Benefits and Harms)

http://www.cadth.ca/media/pdf/htis/april-2011/L_0260_Vent_Covers_final.pdf
(Safety of Air Vents in Psychiatric Units in a Hospital Setting: A Review of the Clinical Evidence and Guidelines)

http://www.cadth.ca/media/pdf/htis/april-2011/RB0349_ESR_Testing_for_Stroke_final.pdf
(Erythrocyte Sedimentation Rate Testing as a Prognostic Indicator for Adult Patients with Transient Ischemic Attack: Clinical Evidence and Guidelines)

National Association of Pharmacy Regulatory Authorities (NAPRA)

Meeting: A meeting of the National Drug Scheduling Advisory Committee (NDSAC) was held on March 6, 2011, with the following Initial Recommendation made:

-Naproxen sodium 220 mg per oral dosage unit (when sold in products labeled with a recommended maximum daily dose of 440 mg, and in package sizes exceeding 6,600 mg) - Schedule III (from Schedule II)

Final approval of NDSAC's Initial Recommendation by NAPRA is deferred until further notice.
http://napra.ca/pages/home/default.aspx?id=2912

Canadian Diabetes Association

Report: The Report entitled, “Diabetes: Canada at the Tipping Point: The Public Perspective; A National Survey”, is available.
http://www.diabetes.ca/documents/get-involved/Environics_survey_report_-_ENGLISH-_Mar_31.pdf

 

~~~~~

 

HEADS UP - April 11, 2011

Notices of Compliance - April 4 - 8, 2011

• There were no new NOCs published this week.

News from Health Canada

Health Canada

Health Advisory: Health Canada is reminding Canadians, including parents and caregivers, about health risks associated with the use of topical benzocaine products, including a rare but potentially serious blood condition known as methemoglobinemia (MetHb).
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_59-eng.php

Health Advisory: Health Canada testing of samples of “Mary Ginseng House 100% Pure High Calibre Pow Sum Ontario Ginseng,” identified the presence of microbial contamination that may pose a health risk to immune-compromised individuals.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_58-eng.php

Therapeutic Products Directorate (TPD)

Consumer Health Advisory

Vivaglobin: CSL Behring Canada Inc, in collaboration with Health Canada, would like to inform you of reports of serious thrombotic events (blood clots) following the use of Vivaglobin®, Immune Globulin Subcutaneous (Human).
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2011/vivaglobin_pc-cp-eng.php

Health Care Professional Advisory

Vivaglobin: CSL Behring Canada Inc, in collaboration with Health Canada, would like to inform you of post-marketing reports that indicate an association of serious thrombotic events with the use of Vivaglobin®, Immune Globulin Subcutaneous (Human).
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/vivaglobin_hpc-cps-eng.php

Notice of Decision: A Notice of Decision has been issued for Gilenya.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/nd_ad_2011_gilenya_137516-eng.php

Newsletter: The Canadian Adverse Reaction Newsletter, Volume 21 - Issue 2 - April 2011 is available.
http://www.hc-sc.gc.ca/dhp-mps/medeff/bulletin/carn-bcei_v21n2-eng.php

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué — Volume 1, No. 16 is available.
http://www.cadth.ca/index.php/en/cadth/products/cadth-communique-home/cadth-communique-vol-1-no-16

Reports: The following reports are available.

http://www.cadth.ca/media/pdf/htis/april-2011/K0341_Transitional_Care_Units_final.pdf
(Transitional Care Units for Patients Awaiting Alternative Care: Comparative Clinical and Cost Effectiveness)

http://www.cadth.ca/media/pdf/htis/april-2011/K0343_Optimal_Caseload_for_Salaried_Physicians_Final.pdf
(Salaried Physicians for Family Practice Caseload: Guidelines)

http://www.cadth.ca/media/pdf/htis/april-2011/RB0344_Patient_Wait_Time_Monitors_Final.pdf
(Patient Wait Time Monitors: Clinical Evidence)

http://www.cadth.ca/media/pdf/htis/april-2011/RB0346_Home_Dialysis_Final.pdf
(Combination of Home-Based Hemodialysis and Peritoneal Dialysis: Clinical Evidence)

http://www.cadth.ca/media/pdf/htis/april-2011/RB0348_Management_of_Calciphylaxis_in_ESRD_Final.pdf
(Management of Calciphylaxis in Adult Patients with End-Stage Renal Disease: Evidence for Optimal Therapy and Guidelines)

http://www.cadth.ca/media/pdf/htis/april-2011/L0257_FES_ChildrenCerebralPalsy_final.pdf
(Functional Electrical Stimulation (FES) for Children with Cerebral Palsy: Clinical Effectiveness)

http://www.cadth.ca/media/pdf/htis/april-2011/RB0347_Glucose_Gel_Final.pdf
(Glucose Preparations for the Treatment of Mild to Moderate Hypoglycemia in Diabetic Patients: Clinical Effectiveness and Guidelines)

http://www.cadth.ca/media/pdf/htis/april-2011/RB0345_Spine_Board_Removal_Final.pdf
(Removal of Spine Boards Prior to X-Ray Clearance for Patients in the Emergency Department: Clinical Evidence and Guidelines)

Pharmaceutical Advertising Advisory Board (PAAB)

Newsletter: The April 2011 issue of the PAAB Review is available.
http://www.paab.ca/local/files/PAAB%20Review%20Newsletter%20April%202011%20E.pdf

Patented Medicine Prices Review Board (PMPRB)

Voluntary Compliance Undertaking: The Chairperson of the Board has accepted a Voluntary Compliance Undertaking (VCU) for Suprane.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=206

 

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JPTCP11080_e106_e120_Carleton%.pdf

JPTCP11082_e134_e151_Hayden%.pdf

JPTCP11081_e121_e133_Rieder%_1.pdf

JPTCP11087_e174_e175_Koren.pdf

Regulatory Notes Archive