Regulatory Notes

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 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 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 2, 2012

Notices of Compliance - December 26 - 30, 2011

• There were no new NOCs published this week.

News from Health Canada

Therapeutic Products Directorate (TPD)

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

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

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

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

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

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

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

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

Patented Medicine Prices Review Board (PMPRB)

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

National Association of Pharmacy Regulatory Authorities (NAPRA)

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

 

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HEADS UP - Dec 30, 2011

Notices of Compliance - December 19-23, 2011

• There were no new NOCs published this week.

News from Health Canada

Health Canada

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

Therapeutic Products Directorate (TPD)

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

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

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

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

National Interest

Gazette II

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

Patented Medicine Prices Review Board (PMPRB)

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

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

National Association of Pharmacy Regulatory Authorities (NAPRA)

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

Public Health Agency of Canada

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

 

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HEADS UP - December 19, 2011

Notices of Compliance - December 12-16, 2011

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

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

News from Health Canada

Health Canada

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

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

Therapeutic Products Directorate (TPD)

Health Care Professional Advisory

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

Consumer Health Advisory

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

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

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

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

 

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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
 

 

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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
 

 

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HEADS UP - November 21, 2011

Notices of Compliance- November 14-18, 2011

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

News from Health Canada

Health Canada

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

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

Biologics, Radiopharmaceuticals & Genetic Therapies Directorate (BGTD)

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

Therapeutic Products Directorate (TPD)

Health Care Professional Advisory

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

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

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

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

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

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

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

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

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

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

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

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

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

National Interest

Federal Government – Chemical Substances Challenge

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

Gazette I

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

Canadian Agency for Drugs and Technologies in Health (CADTH)

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

 

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HEADS UP - November 14, 2011

Notices of Compliance - November 7-11, 2011

• There were no new NOCs published this week.

News from Health Canada

HPFB Inspectorate

Guidance Document: A guidance document: entitled Alternate Sample Retention Site Guidelines has been released.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/form/gui-0014_doc-eng.php

Therapeutic Products Directorate (TPD)

Membership List: A membership list and biographies has been published for the Scientific Advisory Committee on Nonprescription Drugs.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-com/nonpres/sacnpd_ccsmvl_m_bio-eng.php

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-com/nonpres/sacnpd_ccsmvl_ai-eng.php
(Summary of Expertise, Experience and Affiliations and Interests for the Scientific Advisory Committee on Nonprescription Drugs (SAC-NPD)).

Summary Basis of Decision: A Summary Basis of Decision is available for MENTOR MEMORYGEL™ CPG Breast Implants Cohesive III.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/md-im/sbd_smd_2011_mentorcpg_86150-eng.php

Summary Basis of Decision: A Summary Basis of Decision is available for NATRELLE™ Highly Cohesive Silicone-Filled Breast Implants.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/md-im/sbd_smd_2011_natrellecohesive_88573-eng.php

Summary Basis of Decision: A Summary Basis of Decision is available for
NATRELLE™ Highly Cohesive Silicone-Filled Breast Implants And NATRELLE™ Silicone-Filled Breast Implants - Textured Shell With Barrier Layer.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/md-im/sbd_smd_2011_natrelleround_61865_60524-eng.php

Summary Basis of Decision: A Summary Basis of Decision is available for MENTOR MEMORYGEL™ Silicone Gel-Filled Breast Implants.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/md-im/sbd_smd_2011_mentorround-69312-eng.php

News Release: The response of Health Canada to the Report of the Interim Auditor General Chapter 4: Regulating Pharmaceutical Drug has been released.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2011/2011_157-eng.php

Nomination Call for Members:  Health Canada is seeking nominations for members for the Scientific Advisory Committee on Pharmaceutical Sciences and Clinical Pharmacology (SAC-PSCP).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-com/pharma/sacpscp_ccssppc_inv-eng.php

Draft Terms of Reference: Draft terms of reference are available for the Scientific Advisory Committee on Pharmaceutical Sciences and Clinical Pharmacology (SAC-PSCP).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-com/pharma/sacpscp_tor_ccssppc_att-eng.php

Consultation: Health Canada has opened a consultation on proposed changes to the Therapeutic Products Directorate's (TPD) List of Recognized Standards for medical devices.
http://www.hc-sc.gc.ca/dhp-mps/consultation/md-im/consult_md_draft_rec_stand_im_ebauche_norm_lst-eng.php

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

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

National Interest

Federal Government – Chemical Substances Challenge

Chemical Substances Challenge: In November 2011, the Final Screening Assessment Report on Quinoline was released and the related notice was published in the Canada Gazette, Part I, Vol. 145, No. 47 - November 19, 2011.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/quinoline-quinoleine-eng.php

Gazette I

Canadian Environmental Protection Act, 1999:  A final decision has been published after screening assessment of Quinoline.
http://www.gazette.gc.ca/rp-pr/p1/2011/2011-11-19/html/notice-avis-eng.html#d102

Canadian Agency for Drugs and Technologies in Health (CADTH)

Report: CADTH’s work is highlighted in the CIHI report on health care cost drivers.
http://www.cadth.ca/en/media-centre/2011/cadth-work-highlighted-in-cihi-report-on-health-care

Newsletter: The CADTH Communiqué, Volume 1, No. 44 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-vol-1-no-44

Public Health Agency of Canada

Seasonal Flu Guide: A new seasonal flu guide is available.
http://www.phac-aspc.gc.ca/cpho-acsp/statements/20111121-eng.php
 

 

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HEADS UP - November 7, 2011

Notices of Compliance - October 31 - November 4, 2011

• There were no new NOCs published this week.

News from Health Canada

Therapeutic Products Directorate (TPD)

Health Care Professional Advisory

Avastin (bevacizumab): Hoffmann-La Roche Limited (Roche), in consultation with Health Canada, would like to inform you of an important update to the safety information regarding the use of Avastin. A higher incidence of new cases of ovarian failure has been observed in premenopausal women treated with AVASTIN® (bevacizumab).
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/avastin_6_hpc-cps-eng.php

Consumer Health Advisory

Avastin (bevacizumab): Hoffmann-La Roche Limited (Roche), in consultation with Health Canada, has informed Canadian healthcare providers of important new safety information regarding the use of Avastin.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2011/avastin_6_pc-cp-eng.php

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

Notice of Decision: On July 28, 2011, Health Canada issued a Notice of Compliance to Boehringer Ingelheim (Canada) Ltd. for the drug product, Trajenta™.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/nd_ad_2011_trajenta_140881-eng.php

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

Notice of Decision: On October 12, 2011, Health Canada issued a Notice of Compliance to Bayer Inc. for the drug product, Visanne.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/nd_ad_2011_visanne_132174-eng.php

Notice: In accordance with the Processing and Distribution of Semen for Assisted Conception Regulations, processors and importers of donor semen shall give a written notice to Health Canada at least 10 days prior to commencing the processing and/or importation of donor semen and within 90 days of ceasing these activities. The following is a list of Canadian processors and importers that have notified Health Canada of their activities.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/info-prod/don/can_semen_est-eta_can_sperme-eng.php

Health Advisory: CooperVision, in consultation with Health Canada, is expanding the product list of their voluntary worldwide recall of contact lenses. Health Canada is working with the company to identify which products on the Canadian market are affected by the recall.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_156-eng.php

National Interest

Federal Government – Chemical Substances Challenge

Chemical Substances Challenge: In November 2011, the Final Screening Assessment Report on Hexabromocyclododecane (HBCD) was released and the relating notice was published in the Canada Gazette, Part I, Vol. 145, No. 46 - November 12, 2011.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/hexabromo-eng.php

Gazette I

Canadian Environmental Protection Act, 1999:  A final decision has been published after screening assessment of a substance — hexabromocyclododecane (subsection 77(6) and section 68 of the Canadian Environmental Protection Act, 1999).
http://www.gazette.gc.ca/rp-pr/p1/2011/2011-11-12/html/notice-avis-eng.html#d104

Canadian Agency for Drugs and Technologies in Health (CADTH)

Agreement: On October 26, 2011, the Canadian Agency for Drugs and Technologies in Health (CADTH) signed an agreement with the Pan American Health Organization (PAHO), granting PAHO permission to translate the Rx for Change database into Spanish.
http://www.cadth.ca/en/media-centre/2011/cadth-signs-agreement-with-the-pan-american-health

Newsletter: The CADTH Communiqué, Volume 1, No. 43 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-vol-1-no-43

Newsletter: The Common Drug Review Update – Issue 78 is available and discusses changes to the Procedure for Common Drug Review and the Common Drug Review Submission Guidelines for Manufacturers.
http://www.cadth.ca/en/products/cdr/cdr-update/cdr-update-issue-78

Report: A Rapid Response Report has been released on the use of Nabilone for chronic pain management.
http://www.cadth.ca/media/pdf/htis/oct-2011/RC0306-000%20Nabilone%20for%20chronic%20pain.pdf

Report:  A Rapid Response Report has been released on clinical effectiveness and guidelines for compression garments for the treatment of primary and secondary lymphedema.
http://www.cadth.ca/media/pdf/htis/oct-2011/RB0437-000%20Lymphedema.pdf

Patented Medicine Prices Review Board (PMPRB)

Presentation:  Michelle Boudreau, Executive Director, delivered a presentation, Canada’s Patented Medicine Prices Review Board, at the 10th Annual Conference on Market Access, in Toronto.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=1511&id=269

Canadian Institutes for Health Research

Study Results: New research shows steroid medications may slow brain development in preemies.
http://www.cfri.ca/news/media/steroid-medications-may-slow-brain-development-in-preemies.asp
 

 

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HEADS UP- October 31, 2011

Notices of Compliance- October 24-28, 2011

• There were no new NOCs published this week.

News from Health Canada

Health Canada

Health Advisory: Health Canada is advising Canadians that Colgate-Palmolive is recalling their "Colgate Motion Electric Toothbrush". Consumers and retailers should contact the company directly at 1-800-268-6757 or motion@colpal.com for more information.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_146-eng.php

Health Advisory: Patients with a rare condition known as myasthenia gravis who take a fluoroquinolone antibiotic may risk a worsening of their symptoms, including muscle weakness or breathing problems.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_147-eng.php

Foreign Product Alert: Health Canada is advising consumers not to use the following four (4) products due to concerns about possible side-effects: Maxidus capsules, Chao Jimengnan SuperPowerful Man tablets, Fu Yuan Chun capsules and Qing Tian Zhu tablets.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-149-eng.php

Foreign Product Alert: Health Canada is advising consumers not to use the following product due to concerns about possible side-effects: Pancre-Plus (counterfeit).
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-151-eng.php

Foreign Product Alert: Health Canada is advising consumers not to use the following product due to concerns about possible side-effects: Slimming Kapsul.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-152-eng.php

Foreign Product Alert: Health Canada is advising consumers not to use the following three (3) products due to concerns about possible side-effects: Tian Ma Tu Chung Seven Leave Ginseng, Vall-Boon Tongkat Ali and Pao Ni Kang.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-153-eng.php

Foreign Product Alert: Health Canada is advising consumers not to use the following three (3) products due to concerns about possible side-effects: Majun Dua Istimewa, Raja Maajun-Jerat Dan Seret Angin and Horkut Chooi Foong Hor Lok Tan.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-148-eng.php

Foreign Product Alert: Health Canada is advising consumers not to use the following product due to concerns about possible side-effects: Metabolic Advantage.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-150-eng.php

Foreign Product Alert: Health Canada is advising consumers not to use the following product due to concerns about possible side-effects: Zhui Feng Bao Wei San.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-154-eng.php

Biologics, Radiopharmaceuticals & Genetic Therapies Directorate (BGTD)

Record of Meeting: A record of meeting is available for the bilateral meeting of the Nuclear Medicine Alliance and the Biologic and Genetics Therapies Directorate (BGTD).
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/activit/meet-reunion/nma-mm-crr-2011-06-20-eng.php

Therapeutic Products Directorate (TPD)

Health Care Professional Advisory

Pradax/Plavix: Boehringer Ingelheim (Canada) Ltd., and sanofi-aventis Canada Inc. (on behalf of Bristol-Myers Squibb Sanofi Canada partnership) in consultation with Health Canada, would like to alert you to the risk of medication errors associated with name confusion between the anticoagulant Pradax® (dabigatran etexilate) from Boehringer Ingelheim (Canada) Ltd. and the antiplatelet drug Plavix® (clopidogrel bisulfate) from sanofi-aventis Canada Inc.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/plavix_2_hpc-cps-eng.php

Consumer Health Advisory

Pradax/Plavix: Boehringer Ingelheim (Canada) Ltd., and sanofi-aventis Canada Inc. (on behalf of Bristol-Myers Squibb Sanofi Canada partnership) in consultation with Health Canada, would like to alert patients to the risk of medication errors associated with the mix-up of the names of two prescription drugs, Pradax® (dabigatran) and Plavix®(clopidogrel).
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2011/plavix_2_pc-cp-eng.php

Statement: On Oct. 6-7, 2011, representatives from the medical device regulatory authorities of Australia, Brazil, Canada, China, European Union, Japan and United States, as well as the World Health Organisation (WHO), met in Ottawa to address the establishment and operation of a new organization, the International Medical Device Regulators' Forum (IMDRF).
http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/int/statement_imdrf_declar_fiacrmm-eng.php

Draft Guidance Document: A draft guidance document for Clinical Field Sponsors – Clinical Trial Applications has been released for a 90-day comment period. Health Canada will review the comments received during this comment period and revise the Guidance as necessary. A final version of this document will then be posted.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult_draft_ctdcta_ebauche_ctddec-eng.php

www.jptcp.com/files/draft_ctdcta_ebauche_ctddec_eng.pdf

(Guidance document)

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 1, No. 42 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-vol-1-no-42

Canadian Institute for Health Information

Report: The report: National Health Expenditure Trends, 1975 to 2011 is available.
https://secure.cihi.ca/estore/productFamily.htm?locale=en&pf=PFC1671

Report: The report: Health Care Cost Drivers: The Facts is available.
https://secure.cihi.ca/estore/productFamily.htm?locale=en&pf=PFC1672
 

 

~~~~~

 

HEADS UP - October 24, 2011

Notices of Compliance - October 17-21, 2011

• There were no new NOCs published this week.

News from Health Canada

Therapeutic Products Directorate (TPD)

Health Care Professional Advisory

Xigris: Eli Lilly and Company is undertaking a worldwide withdrawal of Xigris® [drotrecogin alfa (activated)] due to new clinical trial findings of lack of efficacy which calls into question the benefit-risk profile of the product.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/xigris_4_hpc-cps-eng.php

Notice to Hospitals

Xigris: Health Canada has endorsed important new benefit-risk information on Xigris [drotrecogin alfa (activated)].
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/xigris_4_nth-aah-eng.php
 
Consumer Health Advisory

Xigris: Eli Lilly and Company is undertaking a worldwide withdrawal of Xigris® [drotrecogin alfa (activated)].
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2011/xigris_4_pc-cp-eng.php

Notice:  Health Canada would like to inform sponsors that drug submissions for brand name changes to their product which require a brand name assessment and/or Look-alike Sound-alike (LA/SA) assessment will no longer be acceptable for processing as an administrative drug submission pursuant to the Policy Changes in Manufacturer's Name and/or Product Name.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/announce-annonce/notice_brandname_clarif_avis_marqnom-eng.php

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

Record of Decisions: A Record of Decisions is available for the June 8, 2011 meeting between Health Canada and Groupement provincial de l'industrie du médicament (GPIM).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/assoc/2011-06-08-eng.php

Notice of Decision: On September 22, 2011, Health Canada issued a Notice of Compliance to Genzyme Canada Inc. for a drug product that contains the medicinal ingredient colesevelam hydrochloride, a bile acid sequestrant. The brand name is yet to be determined.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/nd_ad_2011_colesevelam_hydrochloride_133463-eng.php

Record of Decisions:  An agenda for the bilateral meeting program with the Compressed Gas Association held on October 29, 2011 is available.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/activit/meet-reunion/cga-agm-20091029-eng.php

Guidance Document: Health Canada is pleased to announce the release of the Guidance Document: Preparation of STED-based Class III and Class IV Premarket Medical Device Licence Applications, not including In Vitro Diagnostic Devices (IVDDs).
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/md_gd_im_ld_sted-eng.php

National Interest

Gazette I

Order: The Patented Medicines Prices Review Board has issued an order in Gazette I.
http://www.gazette.gc.ca/rp-pr/p1/2011/2011-10-29/html/commis-eng.html#f110

Canadian Agency for Drugs and Technologies in Health (CADTH)

Announcement: CADTH launches its updated virtual library of diabetes reports, tools, and other resources — conveniently collecting them in one place.
http://www.cadth.ca/en/media-centre/2011/cadths-diabetes-virtual-library

Newsletter: The CADTH Communiqué, Volume 1, No. 41 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-vol-1-no-41

Announcement: The Canadian Agency for Drugs and Technologies in Health (CADTH) today announced the appointment of a Public Member to its recently established Health Technology Expert Review Panel. The Panel is an advisory body, convened to develop guidance and recommendations to CADTH on non-drug health technologies such as medical devices.
http://www.cadth.ca/en/media-centre/2011/4-canadian-agency-for-drugs-and-technologies-in-health

Pharmaceutical Advertising Advisory Board (PAAB)

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

Patented Medicine Prices Review Board (PMPRB)

Analysis Briefs: The PMPRB launches the first issue in its new Analysis Briefs series.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=1568

Newsletter: The October 2011 issue of the PMPRB NEWSletter is available.
http://www.pmprb-cepmb.gc.ca/CMFiles/Publications/Newsletter/News-Oct2011-e-online.pdf
 

 

~~~~~

 

HEADS UP - October 17, 2011

Notices of Compliance - October 10-14, 2011

• Visanne (dienogest) was approved as a progestin on 2011-10-12.

News from Health Canada

Health Canada

Information Update: Health Canada is informing Canadians that it is working with Eli Lilly Canada, Inc. to withdraw the drug Xigris (drotrecogin alfa) from the Canadian market, in light of the company's decision to withdraw Xigris from the market worldwide.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_142-eng.php

Natural Health Products Directorate (NHPD)

Instructional Videos: The Natural Health Products Online Solution has issued five (5) new instructional videos on how to use the various electronic tools and forms.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/online-enligne/video-instruct-eng.php

Advisory: Health Canada is advising Canadians of the voluntary recall by Puresource Inc. of three lots of NOW Brewer's Yeast (10 grain) Tablets due to the presence of an undeclared milk allergen. The products affected by this recall are bottles of 200 tablets (Lot numbers: 1401411, 1365681 and 1343111).
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_143-eng.php

Meeting:  The agenda from the Natural Health Products Program Advisory Committee Meeting #10 held September 19-20, 2011 is available.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/activit/com/program-19-09-2011-eng.php

Therapeutic Products Directorate (TPD)

Health Care Professional Advisory

Strattera (atomoxetine): Eli Lilly Canada Inc. in collaboration with Health Canada would like to inform you of important information from clinical studies regarding the risk of increased blood pressure and increased heart rate with the use of Strattera (atomoxetine).
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/strattera_2_hpc-cps-eng.php

SynchroMed II Implantable Drug Infusion Pumps: An urgent medical device correction letter has been issued. On July 13, 2009, Medtronic sent a Medical Device Correction letter to Healthcare Professionals regarding the potential for reduced battery performance that could lead to sudden loss of therapy in a small percentage of Medtronic Model 8637 SynchroMed® II pumps. The purpose of this communication is to provide you with updated information.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/synchromed_infusion_hpc-cps-eng.php

Consumer Health Advisory

Strattera (atomoxetine): Eli Lilly Canada Inc. together with Health Canada would like to inform patients and their caregivers of important information about the risk of increased blood pressure and increased heart rate with the use of Strattera (atomoxetine).
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2011/strattera_2_pc-cp-eng.php

Summary Basis of Decision: A Summary Basis of Decision is available for Banzel.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2011_banzel_139913-eng.php

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

Overview: An overview of nano-technology-based health products and food is available.
http://www.hc-sc.gc.ca/dhp-mps/nano-eng.php

Notice: A summary has been published of all changes to the Guidance Document for Mandatory Problem Reporting for Medical Devices and the Mandatory Medical Device Problem Reporting Form for Industry.
http://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hpfb-dgpsa/mhpd-dpsc/devices-materiaux_reporting-notification-2011-eng.php

National Interest

Federal Government – Chemical Substances Challenge
Chemical Substances Challenge: The Siloxane D5 Board of Review has published a report.
http://www.ec.gc.ca/lcpe-cepa/6E52AE02-5E01-48B0-86DE-0C366ACC863F/CdR-BoR-D5_eng.pdf

Canadian Intellectual Property Office (CIPO)
Announcement: To facilitate future improvements in electronic commerce and to increase client self-sufficiency, CIPO will soon implement updates to the online application forms for registration of copyright.
http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr03067.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 1, No. 40 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-vol-1-no-40

Patented Medicine Prices Review Board (PMPRB)

Voluntary Compliance Undertaking: The Chairperson of the Board accepted a voluntary compliance undertaking (VCU) for Orgalutran.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=265

Order: The Hearing Panel issued a board order in the matter of Ratiopharm Inc. and the medicine ratio-Salbutamol HFA, concluding the proceedings.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=266

Public Health Agency of Canada

Report:  Report on the State of Public Health in Canada 2011 is now available.
http://www.phac-aspc.gc.ca/cphorsphc-respcacsp/2011/index-eng.php

Canadian Institutes of Health Research

Study Results: The international Structural Genomics Consortium (SGC) has announced that $48.9 million in new funding has been attained. This renewed investment will allow the SGC to further develop its open access research program to support drug discovery and the development of new medicines.
http://www.cihr-irsc.gc.ca/e/20452.html
 

 

~~~~~

 

HEADS UP - October 10, 2011

Notices of Compliance - October 3 - 7, 2011

• Saphris (asenapine) was approved as an antipsychotic agent on 2011-10-07.

On the Move

• The Canadian Agency of Drugs and Technologies in Health (CADTH) wishes to announce changes to its Executive Team. http://www.cadth.ca/en/media-centre/2011/cadth-executive-team-changes

News from Health Canada

Health Canada

Information Update: Health Canada is reviewing the heart-related safety of the prescription antidepressant citalopram. The review is in light of new study data suggesting that high doses (60 mg/day) can affect the electrical activity of the heart. The changes in electrical activity could potentially lead to serious, possibly fatal abnormal heart rhythms.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_134-eng.php

Foreign Product Alert: Health Canada is advising consumers not to use the following four (4) weight loss products due to concerns about possible side-effects: Slim Forte Slimming Capsules, Slim Forte Double Power Slimming Capsules, Slim Forte Slimming Coffee and Meizitang Botanical Slimming Soft Gel.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-141-eng.php

Foreign Product Alert: Health Canada is advising consumers not to use [W.S] Gan Mao Ling or Chaisentomg Baby's Kam Chik San Powder due to concerns about possible side-effects.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-137-eng.php

Foreign Product Alert: Health Canada is advising consumers not to use OxyELITE Pro capsules (often promoted as Oxy Elite Pro capsules) or Pure Fat Three Days Reduce Weight capsules due to concerns about possible side-effects.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-139-eng.php

Foreign Product Alert: Health Canada is advising consumers not to use Huo Li Bao or Ren Sem Tu Chon Chin Kuo Pill due to concerns about possible side-effects.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-138-eng.php

Foreign Product Alert: Health Canada is advising consumers not to use SXL Sexcellence sachets due to concerns about possible side-effects.
http://hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2011/2011-140-eng.php

Meeting: The Honourable Leona Aglukkaq, Minister of Health, held roundtable discussions today with members of the Traditional Chinese Medicine (TCM) community to hear their perspectives on the regulation of Traditional Chinese Medicines in Canada.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2011/2011_135-eng.php

Therapeutic Products Directorate (TPD)

Consultation: Health Canada has opened a consultation on a proposed amendment to the Food and Drug Regulations - Project # 1470 - Non-Medicinal Ingredient (NMI) Formulation.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult_project_projet_1470-eng.php

http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/project_projet-1470_v2-eng.php
(Consultation Document)

Consultation: The Health Products and Food Branch (HPFB) of Health Canada is seeking input on proposals for Phase II of the Summary Basis of Decision (SBD) project.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult_sbd_smd_e_consult-eng.php

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

Notice: A notice has been published related to the Guidance for Industry: Preparation of a Premarket Review Document in Electronic Format for a Class III and Class IV Medical Device Licence Application. It is intended to assist manufacturers and regulatory correspondents in preparing a premarket review document in an electronic format for a Class III and Class IV medical device licence application.
http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/announce-annonce/notice_e-form_class_iii_iv_avis-eng.php

National Interest

Federal Government – Chemical Substances Challenge

Chemical Substances Challenge: A proposed order to add 3 substances in Batch 11 of the Challenge to Schedule 1 of the Canadian Environmental Protection Act, 1999 is available.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-11/index-eng.php#order

Chemical Substances Challenge:  A proposed order to add 1 substance in Batch 6 of the Challenge to Schedule 1 of the Canadian Environmental Protection Act 1999, is available.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-6/index-eng.php#order

Gazette I

Canadian Environmental Protection Act, 1999: An Order adding toxic substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 is available.
http://www.gazette.gc.ca/rp-pr/p1/2011/2011-10-15/html/reg2-eng.html

Gazette II

Canadian Environmental Protection Act, 1999: Order 2011-87-08-01 amending the Domestic Substances List has been published in Gazette II.
http://www.gazette.gc.ca/rp-pr/p2/2011/2011-10-12/html/sor-dors199-eng.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Seminar/Webinar:  A seminar entitled “Can We Reliably Benchmark HTA Organizations?” was given by Dr. Michael Drummond.
http://www.cadth.ca/en/media-centre/2011/can-we-reliably-benchmark-hta-organizations-seminarwebinar

Newsletter: The CADTH Communiqué, Volume 1, No. 39 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-vol-1-no-39

Patient Input:  Information on five (5) drugs (Gelnique, Rapaflo, Asmanex, Xaretto, Visanne) added to the Call for Patient Input for the Common Drug Review Process is available.
http://www.cadth.ca/en/products/cdr/patient-group-input

 

 

~~~~~

 

HEADS UP - September 26, 2011

Notices of Compliance - September 19 - 23, 2011

• Colesevelam Hydrochloride (Colesevelam HCL) was approved as a bile acid sequestrant on 2011-09-22.

• Ruby-Fill (Rubidium Chloride Rb 82) was approved as a diagnostic radiopharmaceutical on 2011-09-20.

News from Health Canada

Health Canada

Announcement: The Government of Canada announced the renewal of its commitment to protect Canadian families and consumers by updating Canada's world-leading Chemicals Management Plan.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2011/2011-128-eng.php

Biologics, Radiopharmaceuticals & Genetic Therapies Directorate (BGTD)

Meeting: Meeting notes are available for the June 14, 2011 meeting between Health Canada and the BIOTECanada Vaccine Industry Committee (VIC).
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/activit/meet-reunion/vic-civ-mm-crr-2011-06-14-eng.php

Natural Health Products Directorate (NHPD)

Update: An update on the Notice to NHP Stakeholders Regarding Natural Health Products Containing Probiotic and Enzymes is available. The NHPD has received correspondence from affected stakeholders and would like to address some of the questions raised.
 

Therapeutic Products Directorate (TPD)

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

Form: A Mandatory Medical Device Problem Reporting Form for Industry is available.
http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/md-mm_form-eng.php

Guidance: A Guidance Document for Mandatory Problem Reporting for Medical Devices is available.
http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_guide/2011-devices-materiaux/index-eng.php

Notice of Compliance with conditions: A Notice of Compliance with conditions (NOC/c) is available for Docetaxel for Injection.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/docetaxel_116151-eng.php

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/docetaxel_fs_fd_116151-eng.php
(Fact Sheet)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/docetaxel_dhcpl_lapds_116151-eng.php
(Dear Health Care Professional Letter)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/docetaxel_qn_aa_116151-eng.php
(Qualifying Notice)

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

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

Notice: A Notice is available regarding the increased scope of submissions being accepted in Electronic Common Technical Document (eCTD) electronic-only filing format.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ctd/ectd/notice_scope_ectd_avis_augm-eng.php

Newsletter: The October 2011 edition of the Canadian Adverse Reaction Newsletter, Volume 21 - Issue 4 is available.
http://www.hc-sc.gc.ca/dhp-mps/medeff/bulletin/carn-bcei_v21n4-eng.php

National Interest

Federal Government – Chemicals Management Plan

Chemicals Management Plan: Information sessions concerning the next phase of the Chemicals Management Plan are being offered via webinars. For information on the dates of these sessions and to find out how to register, please contact p.liaison@ec.gc.ca.
http://www1.webcastcanada.ca/cmp/

Chemical Management Plan: The Government of Canada has launched the next phase of the Chemical Management Plan.
http://www.chemicalsubstanceschimiques.gc.ca/plan/index-eng.php

Canadian Environmental Protection Act, 1999: A proposed Order to add mercury and its compounds to Schedule 1 to the Canadian Environmental Protection Act, 1999 was published.
http://www.chemicalsubstanceschimiques.gc.ca/plan/approach-approche/mercury-mercure-eng.php

Federal Government – Copyright Act

Copyright Modernization Act: The Honourable Christian Paradis, Minister of Industry, and the Honourable James Moore, Minister of Canadian Heritage and Official Languages, announced the reintroduction of the Government of Canada's Copyright Modernization Act.
http://www.ic.gc.ca/eic/site/crp-prda.nsf/eng/h_rp01238.html

http://www.parl.gc.ca/HousePublications/Publication.aspx?Language=E&Mode=1&DocId=5144516
(Bill C-11, Copyright Modernization Act)

Gazette I

Canadian Environmental Protection Act, 1999: An Order has been issued adding toxic substances to Schedule 1 to the Canadian Environmental Protection Act, 1999.
http://www.gazette.gc.ca/rp-pr/p1/2011/2011-10-01/html/reg1-eng.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 1, No. 37 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-vol-1-no-37

Consultation: CADTH is pleased to invite all interested parties to provide feedback on the draft science report and draft recommendations report for the CADTH project Atypical Antipsychotics for Schizophrenia: Combination Therapy and High Doses.
http://www.cadth.ca/en/products/optimal-use/atypical-antipsychotics-for-schizophrenia/aap-call-for-feedback

Newsletter: The CADTH Communiqué, Volume 1, No. 38 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-vol-1-no-38

Patented Medicine Prices Review Board (PMPRB)

Reports: The National Prescription Drug Utilization Information System (NPDUIS) has published the following reports.

http://www.pmprb-cepmb.gc.ca/CMFiles/Publications/Analytical%20Studies/NPDUIS-GenericEntryImpact-e-sept30.pdf
(The Impact of Generic Entry on the Utilization of the Ingredient, September 2011)

http://www.pmprb-cepmb.gc.ca/CMFiles/Publications/Analytical%20Studies/NPDUIS-DispensingFees-e-sept30.pdf
(Public Drug Plan Dispensing Fees: A Cost-Driver Analysis, 2001/02 to 2007/08, September 2011)

http://www.pmprb-cepmb.gc.ca/CMFiles/Publications/Analytical%20Studies/NPDUIS-GenericDrugs-IPCs-e-sept30.pdf
(Generic Drugs in Canada: International Price Comparisons and Potential Cost Savings, September 2011)

Environment Canada

Speech: The Honourable Leona Aglukkaq, Minister of Health, and the Honourable Peter Kent, Minister of Environment, announce the renewal of Canada's world-leading Chemicals Management Plan.
http://www.ec.gc.ca/default.asp?lang=En&n=6F2DE1CA-1&news=6C37C78E-F5DC-4DD2-898D-90B5ADEB3832

Public Health Agency of Canada

Statement: A Statement on Seasonal Influenza Vaccine for 2011–2012 is available.
http://www.phac-aspc.gc.ca/publicat/ccdr-rmtc/11vol37/acs-dcc-5/index-eng.php
 

 

~~~~~

 

HEADS UP - September 19, 2011

Notices of Compliance - September 12 - 16, 2011

• There were no new NOCs published during this week.

News from Health Canada

Health Canada

Health Advisory: Health Canada is informing health professionals and patients of updated recommendations involving the use of Plavix in combination with a class of drugs known as proton pump inhibitors (PPIs).
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_125-eng.php

Biologics, Radiopharmaceuticals & Genetic Therapies Directorate (BGTD)

Record of Meeting: A Record of Meeting is available for the June 10, 2010 meeting of the Expert Advisory Committee - Cells, Tissues and Organs.
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/activit/com/eaccto-ccecto/rom-crr_2010-06-10-eng.php

Therapeutic Products Directorate (TPD)

Records of Decision: A Records of Decision is available for the June 20, 2011meeting between Health Canada and the National Association of Pharmacy Regulatory Authorities (NAPRA).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/assoc/2011-06-20-eng.php

Summary Basis of Decision: A Summary Basis of Decision (SBD) is available for Vimpat.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2011_vimpat_116632-eng.php

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

Consultation: Health Canada has opened a consultation on the Draft Guidance on Good Manufacturing Practices (GMP) for Medical Gases (GUI-0031).
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/docs/gui-0031-consult-eng.php
(draft Guidance) www.jptcp.com/files/Draft_GUI_0031_GMP_for_Medical_Gases.pdf

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

Summary Basis of Decision: A Summary Basis of Decision (SBD) is available for Jevtana.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2011_jevtana_137421-eng.php

Notice of Decision: A Notice for Decision is available for Incivek.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/nd_ad_2011_incivek_142482-eng.php

National Interest

Advertising Standards Canada (ASC)

Newsletter: The ASC Fall 2011 newsletter, enews, is available.
http://adstandards.com/en/ASCLibrary/newsletters/fall2011/newsletter_ASCNews.aspx

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 1, No. 36 is available.

 http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-vol-1-no-36

Newsletter: The Common Drug Review Update — Issue 77 is available and discusses changes to the Procedure for Common Drug Review and the Common Drug Review Submission Guidelines for Manufacturers.
http://www.cadth.ca/en/products/cdr/cdr-update/cdr-update-issue-77

http://www.cadth.ca/media/cdr/process/CDR_Procedure_e.pdf
(Procedure for Common Drug Review)

http://www.cadth.ca/media/cdr/process/CDR_Submission_Guidelines_e.pdf
(Common Drug Review Submission Guidelines for Manufacturers)

Patented Medicine Prices Review Board (PMPRB)

Speech: Mary Catherine Lindberg gave a speech at the Canadian Association for Healthcare Reimbursement: Healthcare and Biopharmaceuticals in Canada – A Federal Perspective conference on September 21, 2011 in Ottawa.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=223

National Association of Pharmacy Regulatory Authorities (NAPRA)

Meeting: A meeting of the National Drug Scheduling Advisory Committee (NDSAC) was held on September 11-12, 2011. The main purpose of the meeting was to conduct a drug scheduling review (initiated at the request of NAPRA) for the nonprescription nonsteroidal anti-inflammatory drugs (NSAIDs), excluding ASA and acetaminophen, currently available on the Canadian market.
http://napra.ca/pages/home/default.aspx?id=2979
 

 

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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
 

 

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HEADS UP - September 12, 2011

Notices of Compliance - August 29 – September 2, 2011

• There were no new NOCs published during this week.

News from Health Canada

Health Canada

Health Advisory: Following information that a Toronto Company, ACCU-METRICS, has been advertising HIV home test kits for sale via their website, Health Canada would like to remind Canadians that there are currently no HIV test kits that have been authorized for home use in Canada.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_123-eng.php

Health Advisory: Health Canada is informing health professionals and patients about a possible increased risk of certain heart-related events in men being treated for prostate cancer with a type of prescription drug known as a Gonadotropin-Releasing Hormone (GnRH) agonist.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_122-eng.php

Natural Health Products Directorate (NHPD)

Notice: The NHPD has issued a notice to NHP stakeholders regarding Enzyme-Containing Natural Health Products.
www.jptcp.com/files/NHPD.Enzymes.9.14.2011.pdf

Probiotics: The NHPD has issued a message to NHP Stakeholders regarding products containing Probiotics.
 www.jptcp.com/files/NHPD_Probiotics_email.9.14.2011.pdf

Survey: The Natural Health Products Directorate has issued an invitation to complete a survey for an evaluation of Health Canada’s BSE I and BSE II Initiatives.
 www.jptcp.com/files/NHPD_Survey.9.8.2011.pdf

Therapeutic Products Directorate (TPD)

Notice of Decision: A Notice for Decision has been issued for Samsca.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/nd_ad_2011_samsca_139413-eng.php

Record of Decisions: A Record of Decisions is available for the June 22, 2011 meeting between Health Canada and Canada's Medical Device Technology Companies (MEDEC).
http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/meet-reunion/2011-06-22-eng.php

Notice of Compliance with conditions (NOC/c): A Notice of Compliance with conditions (NOC/c) has been issued for Sandoz Letrozole.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/sandoz_letrozole_134725-eng.php

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/sandoz_letrozole_fs_fd_134725-eng.php
(Fact Sheet Sandoz Letrozole)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/sandoz_letrozole_dhcpl_lapds_134725-eng.php
(Dear Health Care Professional Letter Sandoz Letrozole)

Notice: As of October 1, 2011, Health Canada will no longer be providing the Validation Reports or email notifications for submissions that have passed validation. Any submissions that have warnings or fails validation will still have a validation report sent to the sponsor.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ctd/ectd/notice_ectd_validation_avis-eng.php

Consultation: The Draft Guidance Document, ‘The Use of Foreign Reviews by Health Canada’, is available for consultation.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult_draft_foreign_rev_ebauche_exam_etra-eng.php

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

National Interest

Federal Government – Chemical Substances Challenge

Chemical Substances Challenge: An Order amending the Domestic Substances List to apply the Significant New Activity provisions of the Canadian Environmental Protection Act, 1999 to six substances in Batch 11 of the Challenge was published.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-11/index-eng.php

Chemical Substances Challenge: An Order amending the Domestic Substances List to indicate that two substances in Batch 11 of the Challenge meet the Reduced Regulatory Requirement polymer criteria under the New Substances Notification Regulations was published.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-11/index-eng.php

Chemical Substances Challenge: The final screening assessment report for one substance (CHPD) in Batch 1 of the Challenge was published.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-1/index-eng.php

Chemical Substances Challenge: The final screening assessments reports for four substances in Batch 6 of the Challenge were published and the proposed risk management approach document was also released for a 60-day public comment period.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-6/index-eng.php

Chemical Substances Challenge: A final screening assessment report for one substance in Batch 8 of the Challenge was published.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-8/index-eng.php

Chemical Substances Challenge: The final screening assessments reports for substances in Batch 11 of the Challenge were published and the proposed risk management approach documents were also released for a 60-day public comment period.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-11/index-eng.php

Gazette I

Canadian Environmental Protection Act, 1999: The publication of the final decision after screening assessment of substances in Batches 6, 8 and 11 of the Chemical Substances Challenge and the publication of results of investigations and recommendations for a substance are available.
http://www.gazette.gc.ca/rp-pr/p1/2011/2011-09-10/html/index-eng.html

Canadian Environmental Protection Act, 1999: The publication of the final decision after screening assessment of a substance, Propanedinitrile, [[4-[[2-(4-cyclohexylphenoxy)ethyl]ethylamino]2-methylphenyl]methylene]- (CHPD), CAS No. 54079-53-7 — specified on the Domestic Substances List (subsection 77(6) of the Canadian Environmental Protection Act, 1999) is available.
http://www.gazette.gc.ca/rp-pr/p1/2011/2011-09-10/html/index-eng.html

Advertising Standards Canada (ASC)

Seminar: ASC's Trends & Topics Seminar Series: Brand Management in a Crisis - Online & Offline will be held on October 24, 2011.
http://www.adstandards.com/en/Events/201110BrandManagementToronto.asp

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 1, No. 34 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-vol-1-no-34

Consultation: CADTH is pleased to invite all interested parties to provide feedback on draft science reports and on a recommendations report for the CADTH project Optimal Warfarin Management for the Prevention of Thromboembolic Events in Patients with Atrial Fibrillation.
http://www.cadth.ca/en/products/optimal-use/warfarin-management/feedback-now-open

Announcement: The latest issue (April-June 2011) of British Columbia-based Therapeutics Initiative’s Therapeutics Letter features CADTH’s work, recommendations, and key messages on the self-monitoring of blood glucose (SMBG).
http://www.cadth.ca/en/media-centre/2011/cadth-work-highlighted-in-article-on-self-monitoring

 

~~~~~

 

HEADS UP - September 5, 2011

Notices of Compliance - August 22 - 26, 2011

• Edurant (rilpivirine hydrochloride) was approved as a human immunodeficiency virus (HIV) non-nucleoside reverse transcriptase inhibitor (NNRTI) on 2011-08-23.

News from Health Canada

Health Canada

Report: The report, “Health Canada Quarterly Financial Report - for the quarter ended June 30, 2011”, is available.
http://www.hc-sc.gc.ca/ahc-asc/performance/estim-previs/qfr-rft/june-2011-eng.php

Health Advisory: Wing Quon Enterprises Ltd has initiated a stop sale and is voluntarily recalling a natural health product, Bi Yan Pian (NPN# 80023876) from the Canadian market after the product was found to contain an excessive amount of mercury.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_117-eng.php

Therapeutic Products Directorate (TPD)

Health Care Professionals Advisory

Uromitexan: Health Canada has endorsed important safety information on Uromitexan (mesna injection) 100mg/mL.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/mesna_hpc-cps-eng.php

Consumer Health Advisory

Uromitexan: Health Canada has endorsed important safety information on Uromitexan (mesna injection) 100mg/mL.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2011/mesna_pc-cp-eng.php

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

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

Notice of Decision: A Notice of Decision is available for Zytiga.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/nd_ad_2011_zytiga_138343-eng.php

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CADTH Communiqué, Volume 1, No. 33 is available.
http://www.cadth.ca/en/products/cadth-communique-home/cadth-communique-vol-1-no-33

 

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Regulatory Notes Archive