Regulatory Notes

HEADS UP - February 22, 2010

Notices of Compliance - February 15 - 19, 2010

• There were no relevant NOCs published this week.

News from Health Canada

Health Canada

Announcement: The Honourable Leona Aglukkaq, Minister of Health, announced the launch of a campaign to help make Canadian families more aware of the environmental health risks around them.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2010/2010_26-eng.php

Announcement: The Honourable Leona Aglukkaq, Minister of Health, announced federal funding of over $1.5 million to the Association of Faculties of Medicine of Canada (AFMC) to strengthen the postgraduate medical education system.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2010/2010_32-eng.php

Foreign Product Alerts: Health Canada is advising consumers not to use the products specified below due to concerns about possible side-effects.

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2010/2010-28-eng.php
(Certain lots (Lot Numbers 494, 520, 520A, 520B, 520C, 521, 705, 706, 779 and 807) of sexual enhancement dietary supplements sold by Atlas Operations Inc.)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2010/2010-27-eng.php
(2H & 2D)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2010/2010-29-eng.php
(65 products sold through Bodybuilding.com)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2010/2010-30-eng.php
(STRO Emperor Capsules)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2010/2010-31-eng.php
(Tian Yang Xu Huo Oral Ulcer Capsule Batch number 0812003, expiry date 11.2011)

Therapeutic Products Directorate (TPD)

Interim Policy Statement: Health Canada is announcing the adoption of an Interim Policy Statement on Health Canada's Working Definition for Nanomaterials.
http://www.hc-sc.gc.ca/sr-sr/consult/_2010/nanomater/index-eng.php

http://www.hc-sc.gc.ca/sr-sr/consult/_2010/nanomater/draft-ebauche-eng.php
(Consultation Document)

Record of Decisions: A Record of Decisions is available for the November 19, 2009 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/2009-11-19-eng.php

National Interest

GAZETTE I

Canadian Environmental Protection Act, 1999: An Order has been issued adding a toxic substance, Benzene, to Schedule 1 to the Canadian Environmental Protection Act, 1999.
http://www.gazette.gc.ca/rp-pr/p1/2010/2010-02-27/html/reg1-eng.html

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HEADS UP - February 15, 2010

Notices of Compliance - February 8 - 12, 2010

• There were no relevant NOCs published this week.

On the Move

• Brian O’Rourke has relinquished his role as Vice-President of the Common Drug Review to focus entirely on being the Acting President and CEO of the Canadian Agency for Drugs and Technologies in Health (CADTH). CADTH is also pleased to announce the following interim organizational assignments until fiscal year-end (March 31, 2010). Barb Shea has been appointed Senior Vice-President, Science Directorates, and will oversee CADTH’s Health Technology Assessment (HTA), Common Drug Review (CDR), and Canadian Optimal Medication Prescribing and Utilization Service (COMPUS) programs. In her new position, Barb will be the primary contact for liaison with industry. Tammy Clifford continues in her current role as Vice-President, HTA, while beginning to develop concepts and plans for the “Advancing the Science” portfolio. Jane Farquharson has been named Acting Vice-President, Communications and Knowledge Exchange (CKE), in addition to her duties as the Director of Knowledge Exchange and the Liaison Program. Glenna Benson remains in her current capacity as Vice-President, Corporate Services. Denis Belanger, Director of Topics and Research, and Sandy Pagotto, Director of Programs and Reviews, are assuming senior director roles. They are responsible for day-to-day operations, and are accountable for the delivery of products and services for each group. Bill Leslie will directly support Barb Shea’s industry liaison work in his current position as Director, Interventions and Outreach.                                            
http://www.cadth.ca/index.php/en/cadth/corporate-profile/executive-news

News from Health Canada

Health Canada

Unauthorized Health Products: Health Canada is warning consumers of unauthorized health products sold under the OM Fusion Distributors LLC label.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2010/2010_23-eng.php

Therapeutic Products Directorate (TPD)

Consumer Health Advisory

Nipro GlucoPro Insulin Syringes: Health Canada has endorsed important safety information on Nipro GlucoPro Insulin Syringes.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2010/glucopro_syringes-seringues_pc-cp-eng.php

Poli-Grip: Health Canada has endorsed important safety information on Poli-Grip.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2010/poligrip_pc-cp-eng.php

Health Care Professional Advisory

Nipro GlucoPro Insulin Syringes: Surgo Surgical Supply is conducting a recall of all Nipro GlucoPro Insulin Syringes. 
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/glucopro_syringes-seringues_hpc-cps-eng.php

Zinc-Containing Denture Adhesives: GlaxoSmithKline (GSK) warns about a potential health risk associated with long-term, excessive use of zinc-containing denture adhesives: Poli-Grip 'Advanced Care', 'Extra Strength' and 'Ultra Fresh'.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/poligrip_hpc-cps-eng.php

Agenda: An agenda is available for the November 13, 2009 meeting of the Scientific Advisory Committee on Respiratory and Allergy Therapies (SAC-RAT).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-com/resp_allerg/sacrat_a_ccstrta_o_2009-11-13-eng.php

Record of Proceedings: A Record of Proceedings is available for the November 13, 2009 meeting of the Scientific Advisory Committee on Respiratory and Allergy Therapies (SAC-RAT).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-com/resp_allerg/sacrat_rop_ccstrta_crd_2009-11-13-eng.php

Committee: Information is available on the Scientific Advisory Committee on Respiratory and Allergy Therapies (SAC-RAT).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-com/resp_allerg/sacrat_tor_ccstrta_att-eng.php

Guidance: The Guidance, “Mandatory and Voluntary Problem Reporting for Medical Devices”, is being updated.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/prob-report-rapport/mavprfmd-rioevraim_tc-tm-eng.php

Summary Basis of Decision: A Summary Basis of Decision (SBD) is available for COBAS Ampliscreen HBV Test (Donor Screening).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/md-im/sbd_smd_2010_cobas_ampliscreen_139526-eng.php

National Interest

Advertising Standards Canada (ASC)

e-Newsletter: The Winter 2010 issue of the ASC Communiqué e-newsletter is available.
http://www.adstandards.com/en/ASCLibrary/newsletters/winter2010_newsletter.html

The Patented Medicine Prices Review Board (PMPRB)

Meeting: A report is available on the November 3, 2009 National Prescription Drug Utilization Information System (NPDUIS) meeting.
http://www.pmprb-cepmb.gc.ca/cmfiles/Jan2010-NPDUIS-e.pdf

 

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HEADS UP - February 8, 2010

Notices of Compliance - February 1 - 5, 2010

•  Cervarix (recombinant human papillomavirus type 16 L1 protein / recombinant human papillomavirus type 18 L1 protein) was approved as an active immunizing agent on 2010-02-03

News from Health Canada

Biologics and Genetic Therapies Directorate (BGTD)

Notice of Decision: A Notice of Decision has been issued for Recothrom.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/nd_ad_2010_recothrom_125888-eng.php

Therapeutic Products Directorate (TPD)

Consumer Health Advisory

NeXus I, II and III Rollators: Dana Douglas Inc. has initiated a voluntary recall of certain neXus I, II and III rollators. Affected rollators may break during use, which could result in the user falling and suffering serious injury including bruising, broken bones or death.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2010/nexus_pc-cp-eng.php

Accutane: Health Canada has endorsed important safety information on Accutane ROCHE (isotretinoin).
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2010/accutane_2_pc-cp-eng.php

Health Care Professional Advisory

Accutane: Hoffmann-La Roche Limited, in consultation with Health Canada, would like to inform prescribers of important new safety information regarding the use of Accutane™ ROCHE ® (isotretinoin).
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/accutane_2_hpc-cps-eng.php

Notice of Decision: A Notice of Decision has been issued for Primovist.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/nd_ad_2010_primovist_127609-eng.php

Summary Basis of Decision: A Summary Basis of Decision (SBD) has been issued for Vibativ.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/sbd_smd_2010_vibativ_107792-eng.php

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

Consultations: CADTH invites all interested parties to provide feedback on its two latest draft reports under the diabetes management priority area.
http://www.cadth.ca/index.php/en/compus/second-line-therapies-type-2-diabetes/feedback

The Patented Medicine Prices Review Board (PMPRB)

New Patented Medicines - 2009: A listing of new Patented Medicines reported to the PMPRB in 2009 is available.
http://www.pmprb-cepmb.gc.ca/cmfiles/English-2009.pdf

Canadian Institutes of Health Research (CIHR)

Study on Reproductive Health: The Canadian Institutes of Health Research (CIHR) is currently funding two teams of researchers from the McGill University Health Centre (MUHC) to study the impact of environmental contaminants on reproductive health.
http://muhc.ca/newsroom/news/cihr-grants-5-million-muhcmcgill-research

Public Health Agency of Canada (PHAC)

Report: A report is available from the National Diabetes Surveillance System: Diabetes in Canada, 2009.
http://www.phac-aspc.gc.ca/publicat/2009/ndssdic-snsddac-09/index-eng.php

 

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HEADS UP - February 1, 2010

Notices of Compliance - January 25 - 29, 2010

•There were no new NOCs published this week.

News from Health Canada

Health Canada

Unauthorized Product: Health Canada is advising consumers that the unauthorized product "Complete 7-Day Cleanse" is being recalled because it contains a number of active ingredients with a combined effect that may pose serious health risks.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2010/2010_19-eng.php

Biologics and Genetic Therapies Directorate (BGTD)

Notice of Decision: A Notice of Decision is available for Prevnar 13.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/nd_ad_2010_prevnar_13_122881-eng.php

Therapeutic Products Directorate (TPD)

Health Care Professional Advisory

Surgical Mesh: Complications have been reported with the Transvaginal Implantation of Surgical Mesh for the Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/surgical-mesh_nth-aah-eng.php

Summary Basis of Decision: A Summary Basis of Decision (SBD) has been issued for Zolinza.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/sbd_smd_2010_zolinza_104562-eng.php

Consultation: Health Canada has released for comment the draft revised guidance document entitled, “Risk Classification of Observations to Donor Semen Establishments (GUI-0053)”.
http://www.hc-sc.gc.ca/dhp-mps/consultation/compli-conform/2010-gui_0053-eng.php

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

Report: The Technology Report entitled, “Recombinant Activated Factor VII for Prevention of Bleeding Unrelated to Hemophilia: Clinical and Economic Systematic Review”, is available.
http://www.cadth.ca/index.php/en/hta/reports-publications/search/publication/960

Public Health Agency of Canada (PHAC)

Announcement: Canada’s Health Minister Leona Aglukkaq, Dr. Simon Sutcliffe, Chair of the Canadian Partnership against Cancer (CPAC) and Sally Brown, CEO, Heart and Stroke Foundation today announced the launch of seven new and highly innovative cancer chronic disease prevention initiatives.
http://www.phac-aspc.gc.ca/media/nr-rp/2010/2010_0203-eng.php

Announcement:  Health Minister Leona Aglukkaq today announced that the Government of Canada is contributing $4.5 million dollars over three years to AboutKidsHealth. 
http://www.phac-aspc.gc.ca/media/nr-rp/2010/2010_0129-eng.php

 

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HEADS UP - January 25, 2010

Notices of Compliance - January 18 - 22, 2010

•  There were no new NOCs published this week.

On the Move

•  Several new employees have joined the Patented Medicine Prices Review Board (PMPRB) over the past few months. Kevin Crombie joined the Board Secretariat and Communications Branch as Communications Manager and Natalie Lowe is the Senior Hearing Officer. George Botulynsky is the new Manager, Investigations Unit, in the Regulatory Affairs and Outreach Branch. John Cook and Theresa Traynor also joined the Branch as Senior Regulatory Officers and Kirk Stanley was appointed to the same position.
http://www.pmprb-cepmb.gc.ca/cmfiles/NEWSletter-January2010.pdf

News from Health Canada

Health Canada

News Release: The Honourable Leona Aglukkaq, Minister of Health and the Honourable Jim Prentice, Minister of Environment, released the draft screening assessment reports and risk management scopes for 14 substances assessed in Batch 8 of the Chemicals Management Plan.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2010/2010_17-eng.php

Unauthorized Health Products: Health Canada is advising consumers not to use any unauthorized health products sold under the brand names Natural Choice Vitamin B-17, Natural Choice Kava Kava and Natural Choice Lithium Orotate.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2010/2010_15-eng.php

Natural Health Products Directorate (NHPD)

Quarterly Report: The Natural Health Products Directorate has released its Status of Applications Quarterly Report-Quarter 3 (Fiscal year 2009-10).
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/report-rapport/qar_tri_3-10-eng.php

Statement: Health Canada has issued a Departmental Statement regarding a NAPRA resolution on Unlicensed NHPs.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/napra-stmt-anorp-avis-eng.php

Therapeutic Products Directorate (TPD)

Consumer Health Advisory

Medications for Parkinson's Disease: Health Canada is aware that two Canadian companies that manufacture and/or distribute medications for Parkinson's Disease have posted information on their websites concerning the availability of some of the drugs they manufacture and/or distribute.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2010/2010_14-eng.php

Glucomannan: Health Canada advises Canadians that Natural Health Products containing Glucomannan may cause serious choking if used with insufficient fluid.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2010/2010_16-eng.php

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

Summary Basis of Decision (SBD) Project: The Therapeutic Products Directorate (TPD) and the Biologics and Genetic Therapies Directorate (BGTD) are pleased to announce the release of the results of the evaluation of phase I of the Summary Basis of Decision (SBD) project.
http://www.hc-sc.gc.ca/dhp-mps/pubs/drug-medic/sbd_er_smd-eng.php

Summary Basis of Decision: A Summary Basis of Decision (SBD) is available for Multaq.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/sbd_smd_2010_multaq_121065-eng.php

Consultation: The purpose of this consultation is to provide an opportunity for comment on the proposed addition of four medicinal ingredients to Part I of Schedule F to the Food and Drug Regulations.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult_project_projet_1621-eng.php

Record of Decisions: A Record of Decisions is available for the October 5, 2009 meeting between Health Canada and the National Association of Pharmacy Regulatory Authorities (NAPRA).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/assoc/2009-10-05-eng.php

Record of Decisions: A Record of Decisions is available for the November 18, 2009 meeting between Health Canada and the Canadian Consumer Specialty Products Association.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/assoc/2009-11-18-eng.php

Report: A Summary Report is available of the Post-Market Reporting Compliance Inspections conducted from September 1, 2005 to March 31, 2008.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/docs/sum_rep_pmrc-rap_som_cedac_ltr-doc-eng.php

Guidance Document: The Guidance document entitled, “Annex 13 to the Current Edition of the Good Manufacturing Practices Guidelines Drugs Used in Clinical Trials (GUI-0036)”, has been updated.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/clini-pract-prat/docs/cln_trials-essais_cln-eng.php

National Interest

GAZETTE I

Canadian Environmental Protection Act, 1999: The screening assessment of substances in Batch 8 of the Chemicals Management Plan and the results of investigations and recommendations for a substance are available.
http://www.gazette.gc.ca/rp-pr/p1/2010/2010-01-30/html/sup-eng.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The January 29, 2010 issue of the COMPUS Communiqué — Vol. 5, No. 7, is available. This issue includes the Self-Monitoring of Blood Glucose: new tools to support recommendations.
http://www.cadth.ca/index.php/en/compus/compus-communique/compus-communique-5-7

The Patented Medicine Prices Review Board (PMPRB)

Newsletter: The January 2010 NEWSletter is available.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=174

Hearing: The Hearing Panel published its decision on the merits in the matter of sanofi pasteur Limited and the medicines Quadracel and Pentacel.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=171

Voluntary Compliance Undertaking: The Chairman of the Board accepted a VCU submitted by Fresenius Kabi Canada regarding the price of Voluven.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=173

 Voluntary Compliance Undertaking: The Chairman of the Board accepted a VCU submitted by Schering-Plough Canada Inc. regarding the price of Claritin Allergy and Sinus Extra Strength.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=172

 

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HEADS UP - January 18, 2010

 

 Notice of Compliance - January 11-15, 2010

 •  Primovist (gadoxetate disodium) was approved as a contrast enhancement agent for magnetic resonance imaging on
2010-01-14.

•  Sanctura XR (trospium chloride) was approved as an antispasmodic on 2010-01-15.

On the Move

•  The Canadian Agency for Drugs and Technologies in Health (CADTH) is pleased to announce the appointment of Dr. Douglas Coyle to the Canadian Expert Drug Advisory Committee (CEDAC), effective January 2010.  CADTH would also like to announce that the following members were reappointed to CEDAC: Dr. Anne Holbrook (Vice-Chair), Mr. Brad Neubauer, Dr. Bruce Carleton, Dr. Kelly Zarnke and Dr. Lindsay Nicolle. CADTH sincerely thanks Dr. Michael Evans, who left the committee in October 2009, for his contributions to the committee.
http://www.cadth.ca/index.php/en/cdr/cdr-update/cdr-update-issue-67

News from Health Canada

Natural Health Products Directorate (NHPD)

Notice: The NHPD has issued a notice regarding Product Licence Applications for Natural Health Products containing Probiotics.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/notice-avis-probioti-01-2010-eng.php

Therapeutic Products Directorate (TPD)

eCTD Format: Health Canada has issued a notice regarding submissions in the Electronic Common Technical Document (eCTD) format.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ctd/ectd/notice_ectd_hybrid_avis-eng.php

Draft Guidance Documents: Draft Guidance Documents are available for the Conduct and Analysis of Comparative Bioavailability Studies; and Comparative Bioavailability Standards: Formulations used for Systemic Effects.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult_draft_ebauche_bios_cbs-eng.php

http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/draft_ebauche_cbs-eng.php
(Consultation Document: Draft Guidance Document - Conduct and Analysis of Comparative Bioavailability Studies)

http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/draft_ebauche_bios-eng.php
(Consultation Document: Draft Guidance Document - Comparative Bioavailability Standards: Formulations used for Systemic Effects)

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 Afinitor.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/nd_ad_2010_afinitor_125809-eng.php

GMP for Drug Submissions: The Therapeutic Products Directorate (TPD) of the Health Products and Food Branch (HPFB) of Health Canada announced the requirements for evidence of Good Manufacturing Practices (GMP) for Drug Submissions.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/notice_gmp_el_avis_bpf_le-eng.php

National Interest

Government of Canada

Final Assessment Report: On January 23, 2010, the results of the final Second Priority Substances List (PSL2) assessment report on three aluminum salts (aluminum chloride, aluminum nitrate and aluminum sulphate) were published in the Canada Gazette, Part I.
http://www.chemicalsubstanceschimiques.gc.ca/about-apropos/assess-eval/alum_salts-sels-eng.php

GAZETTE I

Canadian Environmental Protection Act, 1999: The final decision is available after assessment of Aluminum chloride, CAS No. 7446-70-0; Aluminum nitrate, CAS No. 13473-90-0; and Aluminum sulphate, CAS No. 10043-01-3 — substances specified on the Priority Substances List (subsection 77(6) of the Canadian Environmental Protection Act, 1999).
http://www.gazette.gc.ca/rp-pr/p1/2010/2010-01-23/html/index-eng.html

Pharmaceutical Advertising Advisory Board (PAAB)

Interim Guidance: An Interim Guidance entitled, “Fair Balance in Direct-to-Consumer Advertising of Vaccines”, is available.
http://www.paab.ca/local/files/Vaccine%20guideline.pdf

Canadian Agency for Drugs and Technologies in Health (CADTH)

Update: The CDR Update — Issue 67 is available.
http://www.cadth.ca/index.php/en/cdr/cdr-update/cdr-update-issue-67

The Patented Medicine Prices Review Board (PMPRB)

Voluntary Compliance Undertaking: The Chairman of the Board accepted a Voluntary Compliance Undertaking (VCU) for Xarelto.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=170

 

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HEADS UP - January 11, 2010

Notices of Compliance - January 4 – 8, 2010

  • There were no relevant NOCs published this week.

News from Health Canada

Health Canada

Unauthorized Product: Health Canada is warning consumers not to use the unauthorized product, “The Slimming Coffee”, which was previously sold as ‘Lose Weight Coffee’ because it was found to contain the undeclared prescription drug sibutramine and may pose serious health risks.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2010/2010_06-eng.php

Biologics and Genetic Therapies Directorate (BGTD)

Guidelines: The Guidance entitled, “Validation Guidelines for Pharmaceutical
Dosage Forms (GUIDE-0029)”, has been updated.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/validation/gui_29-eng.php

Natural Health Products Directorate (NHPD)

Fact Sheet: The Fact Sheet entitled, “Drug Identification Number (DIN) to Natural Product Number (NPN) Transition”, is available.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/fiche-info-fact-sheet_din-trans-eng.php

Therapeutic Products Directorate (TPD)

Consumer Health Advisory

Rolaids: Health Canada is informing Canadians that Rolaids antacid tablets packaged in bottles of 150 and 100 counts are being voluntarily recalled in Canada by the distributor, McNeil Consumer Healthcare (Canada).
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2010/2010_08-eng.php

Summary Basis of Decision: A Summary Basis of Decision (SBD) has been issued for Doribax.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/sbd_smd_2010_doribax_113640-eng.php

Notice of Decision: A Notice of Decision has been issued for Precedex.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/nd_ad_2010_precedex_126931-eng.php

National Interest

National Association of Pharmacy Regulatory Authorities (NAPRA)

NDSAC Recommendations: The Initial Recommendations made by the National Drug Scheduling Advisory Committee (NDSAC) on December 15, 2009 for the scheduling of:

• Fluconazole when sold in a concentration of 150 mg per oral dosage unit and indicated for the treatment of vaginal candidiasis, in package sizes containing no more than 150 mg of fluconazole – Schedule III status*
*Pursuant to removal from Schedule F of the Food and Drug Regulations and the issuance of a Notice of Compliance by Health Canada for the non-prescription product formulation

• Oral purgatives containing sodium picosulphate 10 mg per pack (when found in preparations with magnesium oxide 3.5g and citric acid 12g) – Schedule II status were finalized effective January 15, 2010. The National Drug Schedules will be revised accordingly.
http://napra.ca/pages/home/default.aspx?id=2646
 

 

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HEADS UP - January 3, 2010

Notices of Compliance - December 28 - 31, 2009

  • There were no relevant NOCs published this week.

 

News from Health Canada

Health Canada

Unauthorized Product: Health Canada is advising consumers not to use the unauthorized product "Stiff Nights" after the U.S Food and Drug Administration (FDA) found that this product contains an undeclared substance similar to the prescription drug sildenafil and may pose serious health risks, particularly to people with heart problems.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2010/2010_05-eng.php

Foreign Product Alerts: Health Canada is advising consumers not to use the following products due to concerns about possible side-effects.

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2010/2010-01-eng.php
(Full Contact Max Potency)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2010/2010-02-eng.php
(M-Action Batch number CA009A08F)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2010/2010-03-eng.php
(RockHard Weekend and Pai You Guo)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2010/2010-04-eng.php
(Ku Xiu Ba Xiang Jian Fei Wan - Super Slim (Yani) - SHoufsy - MIGAC (sic) FAT BURMING (sic) FACTOR)

Therapeutic Products Directorate (TPD)

Consumer Health Advisory

Optimark: Tyco Healthcare/Covidien, in consultation with Health Canada, wishes to highlight important safety information pertaining to gadoversetamide (Optimark®), a gadolinium-based contrast agent used during magnetic resonance imaging (MRI).
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2010/optimark_pc-cp-eng.php

Health Care Professional Advisory

Optimark: Tyco Healthcare/Covidien, in consultation with Health Canada, would like to inform you of important new safety information regarding Optimark® (gadoversetamide), a gadolinium (Gd)-based contrast agent (GBCA) used to enhance the contrast of magnetic resonance images.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/optimark_hpc-cps-eng.php

Record of Decisions: A Record of Decisions is available for the September 16, 2009 meeting between Health Canada and Consumer Health Products Canada (CHP Canada).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/assoc/2009-09-16-eng.php

Newsletter: The January 2010 issue of the Canadian Adverse Reaction Newsletter is available.
http://www.hc-sc.gc.ca/dhp-mps/medeff/bulletin/carn-bcei_v20n1-eng.php

Food and Drug Regulations: An opportunity for comment has been made available on the proposed addition of three medicinal ingredients - golimumab, lapatinib and its salts, and vorinostat - to Part I of Schedule F to the Food and Drug Regulations.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult_project_projet_1627-eng.php

Food and Drug Regulations: An opportunity for comment has been made available on the proposed addition of four medicinal ingredients - eculizumab, olmesartan medoxomil, romiplostim and ustekinumab - to Part I of Schedule F to the Food and Drug Regulations.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult_project_projet_1624-eng.php

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

Record of Decisions: A Record of Decisions is available for the September 23, 2009 meeting between Health Canada and the Canadian Pharmacists Association.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/assoc/2009-09-23-eng.php

National Interest

Pharmaceutical Advertising Advisory Board (PAAB)

Newsletter: The January 2010 issue of the PAAB REVIEW is available.
http://www.paab.ca/local/files/en/newsletter//PAAB%20Review%20Newsletter%20E.pdf

Canadian Agency for Drugs and Technologies in Health (CADTH)

Deadline Extension: The deadline for consultations on patient input into the Common Drug Review (CDR) process has been extended to January 27, 2010.
http://www.cadth.ca/index.php/en/cdr/cdr-update/cdr-update-issue-66

The Patented Medicine Prices Review Board (PMPRB)

Implementation Date: The implementation date for the Compendium of Policies, Guidelines and Procedures, June 2009 was January 1, 2010.
http://76.74.246.134/english/view.asp?x=1206&all=true

National Association of Pharmacy Regulatory Authorities (NAPRA)

Meeting: The next meeting of the National Drug Scheduling Advisory Committee (NDSAC) is scheduled for March 7-8, 2010. The primary purpose of the meeting is to consider the following matter:

• Request for Unscheduled status for diclofenac diethylamine in preparations for topical use on the skin in concentrations of not more than the equivalent of 1% diclofenac.

http://napra.ca/pages/home/default.aspx?id=2637

 

~~~~~

 

HEADS UP - December 28, 2009

Notices of Compliance - December 14 - 25, 2009

• Afinitor (everolimus) was approved as an antineoplastic agent (mTOR kinase inhibitor) on 2009-12-14.
• Prevnar 13 (pneumococcal polysaccharide serotype 1, pneumococcal polysaccharide serotype 3, pneumococcal polysaccharide serotype 4, pneumococcal   polysaccharide serotype 5, pneumococcal polysaccharide serotype 6A, pneumococcal polysaccharide serotype 6B, pneumococcal polysaccharide serotype 7F, pneumococcal polysaccharide serotype 9V, pneumococcal polysaccharide serotype 14, pneumococcal polysaccharide serotype 18C, pneumococcal polysaccharide serotype 19A, pneumococcal polysaccharide serotype 19F, pneumococcal polysaccharide serotype 23F, corynebacterium diphtheriae CRM-197 protein) was approved as an active immunizing agent on 2009-12-21.
• Recothrom (thrombin alfa) was approved as a coagulation factor on 2009-12-15.
• Targin (oxycodone hydrochloride / naloxone hydrochloride) was approved as an opioid analgesic / opioid antagonist on 2009-12-16.

 

News from Health Canada

Health Canada

Foreign Product Alert: The U.S. Food and Drug Administration informed consumers to stop using Tylenol® Arthritis Pain Caplet 100 count bottles purchased in the United States. The manufacturer has recalled this product after consumer reports of an unusual mouldy, musty, or mildew-like odour that was associated with nausea, stomach pain, vomiting and diarrhea.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2009/2009-213-eng.php

Natural Health Products Directorate (NHPD)

Guidelines: Guidelines are available for the use of Synephrine in natural health products.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/notice-avis-synephrine-eng.php

Guidelines: Guidelines are available for the labeling of natural health products containing sources of gluten as medicinal and/or non-medicinal ingredients.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/notice-avis-gluten_label-etiquet-eng.php

Notice: The purpose of this Notice is to inform stakeholders of upcoming revisions to the Guidance Document on the Application for International Trade Certificates for Natural Health Products.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/notice-avis_itc-cci_2009-eng.php

Therapeutic Products Directorate (TPD)

Consumer Health Advisory

Cerezyme: Health Canada has endorsed important safety information on Cerezyme (imiglucerase for injection).
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2009/cerezyme_pc-cp-eng.php

RevolutionDS Weight Loss: Health Canada warns consumers not to use the unauthorized product, "RevolutionDS Weight Loss".
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2009/2009_211-eng.php

Health Care Professional Advisory

BiCNU: Bristol-Myers Squibb Canada has initiated a voluntary recall of the BiCNU (carmustine for injection) Combo kit Lot number 8K4218A (vial Lot number 1486494C) - expiry date Dec 2011. This recall is being conducted as a precautionary measure due to a sterility assurance concern.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/bicnu_nth-aah-eng.php

Cerezyme: In January 2010, Genzyme Canada expects to begin shipping Cerezyme to all patients who have experienced treatment interruptions. Recommendations for restarting Cerezyme are available.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2009/cerezyme_hpc-cps-eng.php

Food and Drug Regulations - Project 1577 - Schedule F: A Notice of Intent (NOI) has been issued to provide an opportunity for comment on the proposal to amend the current listings in Parts I and II of Schedule F to the Food and Drug Regulations by removing the listings for four medicinal ingredients, thus allowing them to have nonprescription status.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult_project_projet_1577-eng.php

Food and Drug Regulations - Project 1651 - Schedule F: A Notice of Intent (NOI) has been issued to provide an opportunity for comment on the proposal to amend the current listings in Part I of Schedule F to the Food and Drug Regulations for four medicinal ingredients to retain prescription status for specific strengths, uses, routes of administration or dosages while providing exemptions that would allow nonprescription status.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult_project_projet_1651-eng.php

Food and Drug Regulations - Project 1656 - Schedule F: A Notice of Intent (NOI) has been issued to provide an opportunity for comment on the proposal to amend the current listings in Part I of Schedule F to the Food and Drug Regulations for three medicinal ingredients to retain prescription status for specific strengths, uses, routes of administration or dosages while providing exemptions that would allow nonprescription status.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult_project_projet_1656-eng.php

National Interest

GAZETTE I

Canadian Environmental Protection Act, 1999: A Notice has been issued of the twelfth release of technical information relevant to substances identified in the Chemical Substances Challenge.
http://www.gazette.gc.ca/rp-pr/p1/2009/2009-12-26/html/index-eng.html

Food and Drug Regulations: The purpose of this Notice of Intent (NOI) is to provide an opportunity for comment on the proposal to amend the current listings in Parts I and II of Schedule F to the Food and Drug Regulations by removing the listings for four medicinal ingredients, thus allowing them to have non-prescription status. (Project No. 1577)
http://www.gazette.gc.ca/rp-pr/p1/2009/2009-12-26/html/index-eng.html

Food and Drug Regulations: The purpose of this Notice of Intent (NOI) is to provide an opportunity for comment on the proposal to amend the current listings in Part I of Schedule F to the Food and Drug Regulations for four medicinal ingredients to retain prescription status for specific strengths, uses, routes of administration or dosages while providing exemptions that would allow non-prescription status. (Project No. 1651)
http://www.gazette.gc.ca/rp-pr/p1/2009/2009-12-26/html/index-eng.html

Food and Drug Regulations: The purpose of this Notice of Intent (NOI) is to provide an opportunity for comment on the proposal to amend the current listings in Part I of Schedule F to the Food and Drug Regulations for three medicinal ingredients to retain prescription status for specific strengths, uses, routes of administration or dosages, while providing exemptions that would allow non-prescription status. (Project No. 1656)
http://www.gazette.gc.ca/rp-pr/p1/2009/2009-12-26/html/index-eng.html

National Association of Pharmacy Regulatory Authorities (NAPRA)

Newsletter: The December 2009 issue of the NAPRA Notes is available.
http://napra.ca/Content_Files/Files/NAPRA_Notes_December2009_Final.pdf

  ~~~~~

HEADS UP - December 14, 2009

Notices of Compliance - December 7 - 11, 2009

•  Precedex (dexmedetomidine (supplied as dexmedetomidine hydrochloride)) was approved as an alpha2-adrenergic agonist on 2009-12-09.

News from Health Canada

Health Canada

Foreign Product Alerts: Foreign Product Alerts have been issued for the following products:

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2009/2009-209-eng.php
(Zeng Da Yan Shi Wan)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2009/2009-208-eng.php
(Show Party [shou-shen pai*])

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2009/2009-207-eng.php
(Power-Plus P (expiry date 03/03/2011))

Natural Health Products Directorate (NHPD)

Information Sheets: The following Natural Health Products information sheets are available.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/fiche_info_sheets-eng.php

http://www.hc-sc.gc.ca/dhp-mps/prodnatur/fiche_info_sheets_1-eng.php
(Information Sheet #1 - for Retailers - Informing Yourself)

http://www.hc-sc.gc.ca/dhp-mps/prodnatur/fiche_info_sheets_2-eng.php
(Information Sheet #2 - for Health Care Professionals - Helping You Inform Others)

http://www.hc-sc.gc.ca/dhp-mps/prodnatur/fiche_info_sheets_3-eng.php
(Information Sheet #3 - for Health Care Professionals - Informing Yourself)

http://www.hc-sc.gc.ca/dhp-mps/prodnatur/fiche_info_sheets_4-eng.php
(Information Sheet #4 - for Pharmacists - Informing Yourself)

http://www.hc-sc.gc.ca/dhp-mps/prodnatur/fiche_info_sheets_5-eng.php
(Information Sheet #5 - for Consumers - Informing Yourself)

Report: The Natural Health Products Directorate has released its Status of Applications Quarterly Report - Quarter 2 (July 1, 2009 to September 30, 2009).
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/report-rapport/qar_tri_2-09-eng.php

Therapeutic Products Directorate (TPD)

Health Care Professional Advisory

Myfortic: Novartis Pharmaceuticals Canada Inc., in consultation with Health Canada, would like to inform you of important new safety information regarding reports of pure red cell aplasia (PRCA) in patients treated with Myfortic* (mycophenolate sodium) in combination with other immunosuppressive agents.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2009/myfortic_hpc-cps-eng.php

Denture Cleansers: Health Canada has issued a Classification Advisory and Labelling Recommendations to promote the safe use of denture cleansers. All denture cleansers are considered to be accessories to medical devices and are classified as Class I medical devices.
http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/announce-annonce/md_notice_cleansers_im_avis_nettoyage-eng.php

Summary Basis of Decision: A Summary Basis of Decision (SBD) has been issued for Abilify.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/sbd_smd_2009_abilify_120192-eng.php

Notice of Decision: A Notice of Decision has been issued for Firmagon.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/nd_ad_2009_firmagon_120421-eng.php

Notice of Decision: A Notice of Decision has been issued for Toctino.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/nd_ad_2009_toctino_119010-eng.php

Consultation: This Notice of Intent (NOI) is to provide an opportunity for comment on the proposal to amend Part I of Schedule F to the Food and Drug Regulations. The proposed amendment would revise the current listing for L-asparaginase (also known, as asparaginase) to maintain prescription status for injectable dosage forms while providing an exemption from prescription status for other dosage forms.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult_project_projet_1652-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: A Notice of Intent has been issued regarding an opportunity for comment on the proposal to amend the current listing for l-asparaginase (also known as asparaginase) in Part I of Schedule F to the Food and Drug Regulations to maintain prescription status for injectable dosage forms while providing an exemption from prescription status for other dosage forms. (Food and Drug Regulations — Project No. 1652 — Schedule F)
http://www.gazette.gc.ca/rp-pr/p1/2009/2009-12-19/html/index-eng.html

Advertising Standards Canada (ASC)

Trade Dispute Procedure: ASC’s Board of Directors recently approved amendments to the Trade Dispute Procedure (Procedure), which are effective as of January 4, 2010.
http://www.adstandards.com/en/MediaAndEvents/tradeDisputesProcedure.aspx

Canadian Agency for Drugs and Technologies in Health (CADTH)

Report: The report entitled, “H1N1 and Seasonal Influenza Vaccine Practices across Canadian Jurisdictions: Issue 6”, is available.
http://www.cadth.ca/index.php/en/hta/reports-publications/search/publication/956

Report: The Technology Report entitled, “Clopidogrel versus Other Antiplatelet Agents in the Secondary Prevention of Vascular Events in Adults with Cerebrovascular Disease: Clinical and Cost-Effectiveness Analyses”, is available.
http://www.cadth.ca/index.php/en/hta/reports-publications/search/publication/947

Addendum: An addendum to the Canadian Agency for Drugs and Technologies in Health Guidelines for the Economic Evaluation of Health Technologies: Specific Guidance for Oncology Product is available.
http://www.cadth.ca/index.php/en/hta/reports-publications/search/publication/953

CDR Update: CDR Update — Issue 65 discusses CDR changes and documents revisions that are effective immediately and will be reflected in the revised Procedure for Common Drug Review and Common Drug Review Submission Guidelines for Manufacturers, which will be posted in early 2010.
http://www.cadth.ca/index.php/en/cdr/cdr-update/cdr-update-issue-65

CDR Update: CDR Update — Issue 64 discusses a consultation on Fixed Dose Combinations.
http://www.cadth.ca/index.php/en/cdr/cdr-update/cdr-update-issue-64

 ~~~~~

 

HEADS UP - December 4, 2009

Notices of Compliance -November 30- December 4, 2009

•   Silkis (calcitriol) was approved as a topical non-steroidal antipsoriatic agent on 2009-12-01.

                            
News from Health Canada

Health Canada

News Release: The Honourable Leona Aglukkaq, Minister of Health, alongside Pamela Fuselli, Executive Director, Safe Kids Canada and Anu Bose, Head of Ottawa Office for Option Consommateurs, urged all members of the Senate to put the health and safety of Canadians first by restoring Bill C-6, the proposed Canada Consumer Product Safety Act, to its original intended scope.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2009/2009_195-eng.php

News Release: Health Canada will host the 2010 World Health Organization scientific experts meeting on Bisphenol A.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2009/2009_198-eng.php

Foreign Product Alerts: The following foreign product alerts have been issued.

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2009/2009-199-eng.php
(Bodybuilding products manufactured by American Cellular Laboratories that are marketed as containing steroids or steroid-like substances)

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2009/2009-200-eng.php
(S-DROL lot# 810481, expiry date 01/2012)

Newsletter: Health Canada has issued the November 2009 issue of the newsletter, It’s Your Health, which discusses Opioid Pain Medications.
http://www.hc-sc.gc.ca/hl-vs/iyh-vsv/med/ana-opioid-med-eng.php

http://www.hc-sc.gc.ca/hl-vs/iyh-vsv/med/opioid-faq-opioides-eng.php
(Opioid Pain Medications Frequently Asked Questions)

Natural Health Products Directorate (NHPD)

Notice: A notice has been issued on an update on the assessment of naturally-sourced medicinal ingredients found on Schedule F.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/notice-avis_schedulef_annexef-dec2009-eng.php

Therapeutic Products Directorate (TPD)

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

Food and Drug Regulations: The regulatory proposal, Medical Devices Regulations - Amendment - Project 1461 (Quality Management System Certificate) (SOR/2009-303), has been made into a regulation and published in the Canada Gazette Part II.
http://www.hc-sc.gc.ca/dhp-mps/md-im/legislation/gazette2-eng.php

Guidance: The Guidance for Industry entitled, “Preparation of a Premarket Review Document in Electronic Format for a Class IV Medical Device Licence Application”, is available.
http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/announce-annonce/notice_e-form_classiv_avis-eng.php

Guidance: A Guidance Document is available on Voluntary Problem Reporting for Medical Devices (GUI-0060).
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/prob-report-rapport/gui-0060-volu-volo-eng.php

Guidance: A Guidance Document is available on Mandatory Problem Reporting for Medical Devices (GUI-0059).
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/prob-report-rapport/gui-0059-mand-obli-eng.php

Notice of Decision: A Notice of Decision is available for Besivance.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/nd_ad_2009_besivance_123400-eng.php

Notice of Decision: A Notice of Decision is available for Vidaza.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/nd_ad_2009_vidaza_127108-eng.php

Notice of Compliance with conditions: A Notice of Compliance with conditions has been issued for CO Memantine (memantine hydrochloride).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/co-memantine_nocc_122439-eng.php

National Interest

Canadian Agency for Drugs and Technologies in Health (CADTH)

Announcement: The Canadian Agency for Drugs and Technologies in Health (CADTH) has announced a project to pilot conducting therapeutic reviews concurrently with a submission(s) for formulary review.
http://www.cadth.ca/index.php/en/media-centre/2009/12/7/199

Newsletter: The December 10, 2009 issue of the CDR Update — Issue 63 discusses a consultation on Patient Input.
http://www.cadth.ca/index.php/en/cdr/cdr-update/cdr-update-issue-63

National Association of Pharmacy Regulatory Authorities (NAPRA)

Meeting: A meeting of the National Drug Scheduling Advisory Committee (NDSAC) was held on December 6-7, 2009 with the following Initial Recommendations made:

- Fluconazole when sold in a concentration of 150 mg per oral dosage unit and indicated for the treatment of vaginal candidiasis, in package sizes containing no more than 150 mg of fluconazole - be granted Schedule III status*
*Pursuant to removal from Schedule F of the Food and Drug Regulations and the issuance of a Notice of Compliance by Health Canada for the non-prescription product formulation.
- Oral purgatives containing sodium picosulphate 10 mg per pack (when found in preparations with magnesium oxide 3.5g and citric acid 12g) - be granted Schedule II status

Any objections to these Initial Recommendations must be received by the NAPRA office by January 14, 2010.
http://napra.ca/pages/home/default.aspx?id=2620

 

~~~~~

 

HEADS UP - November 30, 2009

Notices of Compliance - November 23 - 27, 2009

•Adcirca (Tadalafil) was approved as a cGMP-specific phosphodiesterase type 5 inhibitor on 2009-11-25.
•Tasigna (Nilotinib Hydrochloride Monohydrate) was issued under NOC/c policy: Commitment 3 as per Letter of Undertaking on 2009-11-26.
                             
 

News from Health Canada

Health Canada

Biologics and Genetic Therapies Directorate (BGTD)

Meeting Minutes: Meeting Minutes are available for the January 20, 2009 meeting between BIOTECanada and Biologics and Genetic Therapies Directorate (BGTD).
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/activit/meet-reunion/biotecanada-mm-crr-2009-01-20-eng.php

Therapeutic Products Directorate (TPD)

Consumer Health Advisory

Zaditen: Health Canada is advising consumers that Montreal-based Paladin Labs Inc., the manufacturer of the prescription asthma drug Zaditen, is recalling lot #440494, which is packaged as blisters of 14 - 1mg tablets.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2009/2009_194-eng.php

Acai Berry Products: Health Canada is advising Canadians not to use certain Acai Berry products after a large number of shipments of adulterated products were stopped at the border. The product names include: Anti-Aging Acai Berry, Guarana Blast, Brazillian Pure, Anti-aging Vital Rez V, Weight Loss VitalAcai, Dietary Supplement Acai Power Blast and Muscle Mass.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2009/2009_197-eng.php

Health Care Professional Advisory

Exjade: There is an advisory concerning proposed changes to the Canadian Product Monograph regarding the use of Novartis Pharmaceuticals Canada Inc.’s Exjade (deferasirox). Review of adverse events for patients treated with Exjade suggests a greater risk of kidney failure, gastrointestinal hemorrhage and death in the elderly and those with myelodysplastic syndrome. Creatinine clearance and/or serum creatinine should be assessed twice before starting therapy, weekly in the first month after start/change of therapy, and then monthly.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2009/exjade_3_hpc-cps-eng.php

Document: Health Canada has published a document entitled, “An Overview of the Marketed Health Products Directorate.”
http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_fs-if/2008-mhpd-dpsc-overview-apercu/index-eng.php

Document: Health Canada has published a document entitled, “Health Product Review: An Ongoing Process.”
http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_fs-if/2008-health-sante-prod-rev-exam/index-eng.php

Document: Health Canada has published a document entitled, “The Post-Market Surveillance Continuum - Maximizing Safety, Minimizing Risk.”
http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_fs-if/2008-pmsc-csamm-max/index-eng.php

Document: Health Canada has published a document entitled, “Working Together for a Better Post-Market Surveillance Program.”
http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_fs-if/2008-pmsp-psamm/index-eng.php

Document: Health Canada has published a document entitled, “Reaching out - Programs, Resources and Tools.”
http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_fs-if/2008-reaching-forger/index-eng.php

Document: Health Canada has published a document regarding the Marketed Health Products Directorate (MHPD) entitled, “Looking Ahead.”
http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_fs-if/2008-looking-regarde/index-eng.php

Notice: Health Canada is pleased to announce the release of the finalized Post-Notice of Compliance (NOC) Changes Guidance Documents.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/postnoc_change_apresac/noc_postnotice_ac_apresavis_change-eng.php

Guidance: A guidance document entitled, “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

Guidance: A guidance document entitled, “Post-Notice of Compliance (NOC) Changes: Quality Document” is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/postnoc_change_apresac/noc_pn_quality_ac_sa_qualite-eng.php

Guidance: A guidance document entitled, “Post-Notice of Compliance (NOC) Changes: Safety and Efficacy Document” is available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/postnoc_change apresac/noc_pn_saf_ac_sa_inn-eng.php

Guidance: The final version of this Health Canada guidance document Human-Use Antiseptic Drugs is now available.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/antiseptic_guide_ld-eng.php

Consultation: Draft (Step 2) International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance: Annex 11 to ICH Q4B: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Capillary Electrophoresis General Chapter has been released for comment.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult_q4b_step2_notice_etape2_avis_annex11-eng.php

http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/q4b_step2_notice_etape2_avis_annex11-eng.php
(Consultation Document)

Consultation: Draft (Step 2) International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance: Annex 12 to ICH Q4B: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Analytical Sieving General Chapter has been released for comment.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult_q4b_step2_notice_etape2_avis_annex12-eng.php

http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/q4b_step2_notice_etape2_avis_annex12-eng.php
(Consultation Document)

Consultation: Draft (Step 2) International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance: S6(R1): Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals has been released for comment.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult_s6_step2_notice_etape2_avis-eng.php

http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/s6_step2_notice_etape2_avis-eng.php
(Consultation Document)

Consultation: Food and Drug Regulations - Project #1596 - Schedule F Amendment has been released for comment.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult_project_projet_1596-eng.php

http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/project_projet_1596-eng.php
(Consultation Document)

National Interest

GAZETTE II

Canadian Environmental Protection Act, 1999: Order 2009-66-11-01 amending the Domestic Substances List is available.
http://www.gazette.gc.ca/rp-pr/p2/2009/2009-12-09/html/sor-dors310-eng.html

Canadian Environmental Protection Act, 1999: Order 2009-87-11-01 amending the Domestic Substances List is available.
http://www.gazette.gc.ca/rp-pr/p2/2009/2009-12-09/html/sor-dors309-eng.html

Food and Drug Regulations: Regulations amending the Food and Drug Regulations (1594 - Schedule F) are available.
http://www.gazette.gc.ca/rp-pr/p2/2009/2009-12-09/html/sor-dors305-eng.html

Food and Drug Regulations: Regulations amending the Medical Devices Regulations (1461 - Quality Management System Certificates) are available.
http://www.gazette.gc.ca/rp-pr/p2/2009/2009-12-09/html/sor-dors303-eng.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Report: The report entitled, “Reassessment of Health Technologies: Obsolescence and Waste,” is available.
http://www.cadth.ca/index.php/en/hta/reports-publications/search/publication/946

http://www.cadth.ca/media/pdf/494_Reassessment_of_HT_Obsolescence_and_Waste_tr_e.pdf
(Full Report)

http://www.cadth.ca/media/pdf/494_Executive_Summary_e.pdf
(Executive Summary)

Newsletter: The November 2009 issue of the Health technology Update is available.
http://www.cadth.ca/media/pdf/hta_htupdate_issue12_e.pdf

Report: The Optimal Therapy Report entitled, “Summary Report: Optimal Prescribing and Use of Blood Glucose Test Strips for Self-Monitoring of Blood Glucose” is available.
http://www.cadth.ca/index.php/en/compus/compus-publications/publication/949

http://www.cadth.ca/media/pdf/C1109_bgts_summary_report_e.pdf
(Report)

Report: The report entitled, “Portable Monitoring Devices for Diagnosis of Obstructive Sleep Apnea at Home: Review of Accuracy, Cost-Effectiveness, Guidelines, and Coverage in Canada”, is available.
http://www.cadth.ca/index.php/en/hta/reports-publications/search/publication/950

http://www.cadth.ca/media/pdf/M0002_Portable_Monitoring_Devices_Obstructive_Sleep_Apnea_L3_e.pdf
(Report)

http://www.cadth.ca/media/pdf/M0002_Executive%20Summary_e.pdf
(Executive Summary)

Newsletter:  The December 8, 2009 issue of the COMPUS Communiqué - Vol.5. No.6 is available.
http://www.cadth.ca/index.php/en/compus/compus-communique/compus-communique-5-6

~~~~~
 

HEADS UP - November 23, 2009

Notices of Compliance - November 16 - 20, 2009

•  Firmagon (degarelix) was approved as a gonadotropin-releasing hormone receptor antagonist on 2009-11-16.
•  Jurnista (hydromorphone hydrochloride) was approved as an opioid analgesic on 2009-11-18.

 
News from Health Canada

Health Canada

Chemicals Management Plan: The Honourable Leona Aglukkaq, Minister of Health, and the Honourable Jim Prentice, Minister of the Environment, announced the release of the final screening assessments for 14 of the 18 chemicals assessed in Batch 6 of the Chemicals Management Plan.
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2009/2009_192-eng.php

Document: Health Canada has published the document entitled, “Misconceptions about Vaccine Safety”.
http://www.hc-sc.gc.ca/hl-vs/iyh-vsv/med/misconception-eng.php

Biologics and Genetic Therapies Directorate (BGTD)

Guidance: Health Canada has published the guidance document entitled, “Requirements for Efficacy Claims against the 2009 (H1N1) Pandemic Influenza A Virus for Hard Surface Disinfectant Drug Products”.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/disinfect-desinfect/notice_avis_disinfectant_h1n1_ld-eng.php

Therapeutic Products Directorate (TPD)

Consumer Health Advisory

Heparin: Health Canada is informing health care professionals and Canadians of recent changes to heparin manufacturing standards in the United States that will result in a decrease in the potency of certain heparin products by about 10 per cent.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2009/2009_191-eng.php

Health Care Professional Advisory

Rapamune: Wyeth (a Pfizer company), in collaboration with Health Canada, would like to bring your attention to the fact that different laboratory assays used to measure Rapamune trough concentrations generate results that are not interchangeable.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2009/rapamune_4_hpc-cps-eng.php

Unfractionated Heparin Products: Health Canada has issued an advisory on the decreased potency of some Unfractionated Heparin Products as a result of new United States Pharmacopeia (USP) Standards.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2009/heparin_2_nth-aah-eng.php

Summary Basis of Decision: A Summary Basis of Decision (SBD) has been issued for Clolar.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/sbd_smd_2009_clolar_121874-eng.php

Guidance: Health Canada has published the guidance document entitled, “How to Pay Fees”.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/costs-couts/crpay_rcfrais_for-eng.php

Guidance: The Management of Drug Submissions Guidance has been revised to include changes as a consequence of the release on September 30, 2009 of the finalized Post-Notice of Compliance (NOC) Changes Guidance Documents.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/mgmt-gest/mands_gespd-eng.php

National Interest

GAZETTE I

Canadian Environmental Protection Act, 1999: The results of investigations and recommendations for a substance — Phenol, 2,2 ′ -methylenebis[6-(1,1-dimethylethyl)-4-methyl-—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/p1/2009/2009-11-28/html/index-eng.html

Canadian Environmental Protection Act, 1999: The final decision after screening assessment of Phenol, 2-methyl-4,6-dinitro — a substance specified on the Domestic Substances List (subsection 77(6) of the Canadian Environmental Protection Act, 1999) has been published.
http://www.gazette.gc.ca/rp-pr/p1/2009/2009-11-28/html/index-eng.html

Canadian Environmental Protection Act, 1999: The final decision after screening assessment of substances — Batch 6 and publication of results of investigations and recommendations for substances are available.
http://www.gazette.gc.ca/rp-pr/p1/2009/2009-11-28/html/sup1-eng.html

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The November 12, 2009 issue of the COMPUS Communiqué Vol. 5, No. 5, is available.
http://www.cadth.ca/index.php/en/compus/compus-communique/compus-communique-5-5

Report: The report entitled, “The Location of High-Intensity Focused Ultrasound Facilities in Canada for the Treatment of Prostate Cancer and Access to Treatment - Issue 4”, is available.
http://www.cadth.ca/index.php/en/hta/reports-publications/environmental-scans/issue-4

Report: The report entitled, “Implications of ISO Certification and Licensing of Patient Management Software: Issue 5”, is available.
http://www.cadth.ca/index.php/en/hta/reports-publications/environmental-scans/issue-5

Canadian Institute of Health Research

News Release: The Canadian Institutes of Health Research (CIHR), the National Research Council's Canada Institute for Scientific and Technical Information, and the US National Library of Medicine have partnered to create Pub Med Central (PMC) Canada-a free digital archive of peer-reviewed health science research.
http://www.cihr-irsc.gc.ca/e/40685.html

Canadian Institute for Health Information (CIHI)

Report: The report entitled, “Proton Pump Inhibitor Use in Seniors: An Analysis Focusing on Drug Claims, 2001 to 2008”, is available.
http://secure.cihi.ca/cihiweb/dispPage.jsp?cw_page=media_20091201_e

Patient Cost Estimator: CIHI has announced the availability of the Patient Cost Estimator, a new interactive tool that shows estimated patient costs.
http://secure.cihi.ca/cihiweb/en/downloads/PCE_overview_e.pdf

 

~~~~~

 

 

HEADS UP - November 16, 2009

Notices of Compliance - November 9 - 13, 2009

• Toctino (alitretinoin) was approved as an immunomodulator / anti-inflammatory agent on 2009-11-13.
                             

News from Health Canada

Health Canada

Advisory: Health Canada has issued an advisory entitled, “Buying Drugs over the Internet”.
http://www.hc-sc.gc.ca/hl-vs/iyh-vsv/med/internet-eng.php

Therapeutic Products Directorate (TPD)

Consumer Health Advisory

Herblex "Once More": Health Canada is warning consumers not to use Herblex "Once More", an unauthorized product promoted to enhance male sexual performance, as this product may pose serious health risks.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2009/2009_189-eng.php

Health Care Professional Advisory

Genzyme Corporation Products: Health Canada is informing health care professionals and Canadians that routine quality control testing has discovered foreign particles in a small number of vials of five products filled at a Genzyme Corporation facility in Boston.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2009/2009_190-eng.php

Medical Device Regulations: The following regulatory proposal has been made into a regulation and is published in the Canada Gazette Part II - Medical Devices Regulations - Amendment - Project 1461 (Quality Management System Certificate) (SOR/2009-303).
http://www.hc-sc.gc.ca/dhp-mps/md-im/legislation/gazette2-eng.php

Notice of Decision: A Notice of Decision has been issued for Vibativ.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/nd_ad_2009_vibativ_107792-eng.php

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

Notice of Compliance with conditions: A Notice of Compliance with conditions has been issued for pms-Memantine (memantine hydrochloride).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/pms-memantine_nocc_121144-eng.php

Qualifying Notice: A Qualifying Notice has been issued for ratio-Memantine.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/ratio-memantine_qn_aa_119079-eng.php

National Interest

Federal Government

Chemical Substances Challenge: The Challenge Advisory Panel Summary Reports for Batches 6 and 7 have been published. Government responses to recommendations from the Challenge Advisory Panel are also available.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/panel-groupe/summary-sommaire/_2009/20090727-eng.php

Pharmaceutical Advertising Advisory Board (PAAB)

Guidance: The Guidance for Advertising/Promotional Systems (APS) Which Are Openly Visible in Healthcare Professional (HCP) – Patient Interaction Areas has been revised.
http://www.paab.ca/local/files/Guidance%20for%20APS%20E%2011%2018%202009.pdf

Canadian Intellectual Property Office (CIPO)

Consultation Update: A public consultation on obtaining a filing date during weekends and holidays was held from June 1st to September 14, 2009. Comments were received from six stakeholders. These comments are under consideration, and CIPO would like to thank stakeholders for contributing to the consultative process.
http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr01882.html

The Canadian Institute of Health Information (CIHI)

Report: The report entitled, “National Health Expenditure Trends, 1975 to 2009”, is available.
http://secure.cihi.ca/cihiweb/dispPage.jsp?cw_page=media_20091119_e

http://secure.cihi.ca/cihiweb/products/National_health_expenditure_trends_1975_to_2009_en.pdf
(Report)

 

~~~~~

HEADS UP - November 2, 2009

Notices of Compliance - October 26 - 30, 2009

•  Ixiaro (inactivated Japanese encephalitis virus (attenuated strain SA14-14-2 produced in vero cells)) was approved as an active immunizing agent on 2009-10-29.

News from Health Canada

Health Canada

Statement: Health Canada has issued the 2008-2009 Statement of Management Responsibility.
http://www.hc-sc.gc.ca/ahc-asc/performance/estim-previs/dpr-rmr/2008-2009-smr-drd-eng.php

Natural Health Products Directorate (NHPD)

Report: The NHPD Status of Applications Quarterly Report is available for Quarter 2 (July 1, 2009 to September 30, 2009).
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/report-rapport/qar_tri_2-09-eng.php

Notice: A notice has been issued to Product Licence Applicants regarding the availability of an Evidence Criteria and Evidence Assessment Template.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/notice-avis_evid-preuv_temp-model-eng.php

Therapeutic Products Directorate (TPD)

Consumer Health Advisory

Chaotic Beverages: Health Canada is advising Canadians not to consume Chaotic Beverages sold under the brand names Mind Strike, Fearocity, Elixir of Tenacity and Power Pulse because they are unauthorized products marketed to a vulnerable population (children) with ingredients that may pose a health risk.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2009/2009_180-eng.php

Health Care Professional Advisory

Relenza: There is a possible association of Relenza® (zanamivir) Dry Powder for Inhalation with fatal outcome when administered by nebulization, an unapproved use.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2009/relenza_nth-aah-eng.php

Consultation: An opportunity for comment has been provided on proposed changes to the regulations amending the Food and Drug Regulations 1447 - Good Manufacturing Practices.
http://www.hc-sc.gc.ca/dhp-mps/consultation/compli-conform/2009-reg1447-gmp-bpf-eng.php

http://www.hc-sc.gc.ca/dhp-mps/consultation/compli-conform/2009-reg1447-gmp-bpf-lett-eng.php
(Cover letter - Proposed Amendments)

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

Notice of Compliance with conditions: A Notice of Compliance with conditions has been issued for ratio-Memantine (memantine hydrochloride).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/ratio-memantine_nocc_119079-eng.php

National Interest

The Canadian Institutes of Health Research (CIHR)

Announcement: The Canadian Institutes of Health Research (CIHR) and the Natural Sciences and Engineering Research Council of Canada (NSERC) are pleased to announce the results of the Open Grants Alternative Radiopharmaceuticals for Medical Imaging Competition.
http://webapps.cihr-irsc.gc.ca/cfdd/db_search?p_language=E&p_competition=200909MIS

Health Council of Canada (HCC)

Report: The report entitled, “Safer Health Care for "Sicker" Canadians: International Comparisons of Health Care Quality and Safety”, is available.
http://healthcouncilcanada.ca/en/index.php?page=shop.product_details&flypage=shop.flypage&product_id=108&category_id=16&manufacturer_id=0&option=com_virtuemart&Itemid=170

 ~~~~~

 

 

HEADS UP - October 5, 2009

Notices of Compliance - September 28 - October 2, 2009

•  Norditropin NordiFlex, Norditropin SimpleXx (somatropin) was approved as a growth hormone on 2009-10-01.

•  Endometrin (progesterone) was approved as a progestin on  2009-10-02.

•  Vibativ (telavancin (supplied as telavancin hydrochloride)) was approved as an antibiotic on 2009-09-29.

On the Move

•  Tim Veregin will be leaving CADTH as of October 8, 2009 to pursue other opportunities. Industry and those filing submissions should contact Trinh Luong, Director, Submissions and Operations, for all CDR submission-related inquiries. Trinh joined CADTH on September 28.
http://www.cadth.ca/index.php/en/cdr/cdr-update/cdr-update-issue-61

News from Health Canada

Health Canada

Foreign Product Alerts: Health Canada is advising consumers not to use the following products due to concerns about possible side-effects.

http://hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2009/2009-168-eng.php
(Syntrax Fyre, Texiao Fengshi Gutong Ling,Kam Yuen Brand Wan Ying Yang Gan Wan)

http://hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2009/2009-167-eng.php
(STEAM)

http://hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2009/2009-166-eng.php
(Dynasty Worldwide Jinglida So Young Formula)

http://hc-sc.gc.ca/ahc-asc/media/advisories-avis/_fpa-ape_2009/2009-165-eng.php
(Bao Ling)

Biologics and Genetic Therapies Directorate (BGTD)

Notice of Compliance with conditions: A Notice of Compliance with conditions has been issued for Cayston (aztreonam for inhalation solution).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/cayston_gilead_nocc_120872-eng.php

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/cayston_gilead_fs_fd_120872-eng.php
(Fact Sheet – Cayston)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/cayston_gilead_dhcpl_lapds_120872-eng.php
(Dear Health Care Professional Letter)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/cayston_gilead_qn_aa_120872-eng.php
(Qualifying Notice)

Therapeutic Products Directorate (TPD)

Health Care Professional Advisory

Recall: Smiths Medical is performing a voluntary Urgent Medical Device Recall regarding Portex® Uncuffed Pediatric Sized Tracheal Tubes.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2009/portex_hpc-cps-eng.php

Summary Basis of Decision: A Summary Basis of Decision has been issued for Natrelle Silicone-Filled Breast Implants: Smooth Shell with Barrier Layer, Textured Shell with Barrier Layer.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/md-im/sbd_smd_2009_natrelleround_61865_60524-eng.php

Notice of Decision: A Notice of Decision is available for Doribax.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/nd_ad_2009_doribax_113640-eng.php

Application Form: An application form for Custom-Made Devices and Medical Devices for Special Access is available.
http://www.hc-sc.gc.ca/dhp-mps/acces/md-im/sap_pas_form-eng.php

Newsletter: The October 2009 issue of the Canadian Adverse Reaction Newsletter, Volume 19 - Issue 4, is available.
http://www.hc-sc.gc.ca/dhp-mps/medeff/bulletin/carn-bcei_v19n4-eng.php

National Interest

GAZETTE II

Food and Drug Regulations: Regulations amending the Food and Drug Regulations (1591 – Schedule F) are available.
http://www.gazette.gc.ca/rp-pr/p2/2009/2009-10-14/html/sor-dors279-eng.html

Pharmaceutical Advertising Advisory Board (PAAB)

Newsletter: The October 2009 issue of the PAAB Review is available.
http://www.paab.ca/local/files/en/newsletter//PAAB%20Review%20Newsletter%20October%202009%20E.pdf

Canadian Agency for Drugs and Technologies in Health (CADTH)

Newsletter: The CDR Update — Issue 61 is available.
http://www.cadth.ca/index.php/en/cdr/cdr-update/cdr-update-issue-61

Report: The Health Technology Assessment Rapid Review report entitled, “Radioimmunotherapies for Non-Hodgkin Lymphoma: Systematic Review of Clinical Effectiveness, Cost-Effectiveness, and Guidelines”, is available.
http://www.cadth.ca/index.php/en/hta/reports-publications/search/publication/930

National Association of Pharmacy Regulatory Authorities (NAPRA)

Meeting: The next meeting of the National Drug Scheduling Advisory Committee (NDSAC) meeting is scheduled for December 6-7, 2009. The primary purpose of the meeting is to consider the following matters:

• Request for Schedule II status for oral purgatives containing sodium picosulphate 10 mg per pack (when found in preparations with magnesium oxide 3.5g and citric acid 12g).

• Request for Schedule III status for fluconazole 150 mg single dose administration for vaginal candidiasis pending final amendment of Part I of Schedule F to the Food and Drug Regulations to remove fluconazole sold in a concentration of 150 mg per oral dosage unit and indicated for the treatment of vaginal candidiasis.

http://napra.ca/pages/home/default.aspx?id=2572

 ~~~~~

 

HEADS UP - September 28, 2009

Notices of Compliance - September 21 - 25, 2009

• Janumet (sitagliptin (supplied as sitagliptin phosphate monohydrate) / metformin hydrochloride) was approved as an oral antihyperglycemic agent / DPP- 4 inhibitor / incretin enhancer on 2009-09-24.

On the Move

• The Honourable Leona Aglukkaq, Minister of Health, announced the appointment of Dr. Bernard Prigent to the Governing Council of the Canadian Institutes of Health Research (CIHR) for a three-year term. http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2009/2009_159-eng.php

News from Health Canada

Health Canada

Sleep Aid Drugs: Health Canada is informing consumers and health professionals of recent changes to the labelling information of prescription sleep aid medications used in the short-term treatment of insomnia.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2009/2009_161-eng.php

Biologics and Genetic Therapies Directorate (BGTD)

Summary Basis of Decision: A Summary Basis of Decision is available for Omnitrope.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/sbd_smd_2009_omnitrope_113380-eng.php

Summary Basis of Decision: A Summary Basis of Decision is available for Simponi.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/sbd_smd_2009_simponi_120525-eng.php

Natural Health Products Directorate (NHPD)

Revised Guidelines: Revised Guidelines are available for the use of Stevia in Natural Health Products.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/notice-avis-stevia-eng.php

Notice: The NHPD has issued a Notice concerning Gluten-free Claims for Natural Health Products.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/notice-avis-sans_gluten_free-eng.php

Therapeutic Products Directorate (TPD)

Health Care Professional Advisory

Hospira Devices: Health Canada has endorsed important safety information on Hospira Devices that have defective AC power cords.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2009/hospira_hpc-cps-eng.php

Meeting: A Record of Decisions is available for the March 5, 2009 meeting of the Canadian Society of Hospital Pharmacists.

 

~~~~~

HEADS UP September 21, 2009

Notices of Compliance - September 14 - 18, 2009

  •  GlucaGen, GlucaGen HypoKit (glucagon (supplied as glucagon hydrochloride)) was approved as a hyperglycemic agent on 2009-09-17.
  • Onglyza (saxagliptin (supplied as saxagliptin hydrochloride) was approved as an oral antihyperglycemic agent, DPP-4 inhibitor, incretin enhancer on 2009-09-16

News from Health Canada

Health Canada

 FDA Alert: Health Canada is aware of an alert issued by the U.S. Food and Drug Administration (FDA) regarding dosing errors associated with the liquid form of Tamiflu (the brand name for the drug oseltamivir) and is investigating the issue in Canada.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2009/2009_158-eng.php
 
Biologics and Genetic Therapies Directorate (BGTD)
 
Notice of Decision: A Notice of Decision has been issued for Cimzia.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/nd_ad_2009_cimzia_120296-eng.php
 
Therapeutic Products Directorate (TPD)
 
Summary Basis of Decision: A Summary Basis of Decision has been issued for Mentor MemoryGel CPG Breast Implants Cohesive III.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/md-im/sbd_smd_2009_mentorcpg_86150-eng.php
 
Guidance: A Guidance Document is available on Post-Notice of Compliance (NOC) Changes.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/noc_postnotice_interim_ac_apresavis_entre-eng.php
 
Guidance: A Guidance Document is available on Post-Drug Identification Number (DIN) Changes.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/change_din-eng.php
 
Consultation: An opportunity for comment has been provided on the proposed addition of three medicinal ingredients to Part I of Schedule F to the Food and Drug Regulations.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult_project_projet_1597-eng.php
 
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/project_projet_1597-eng.php
(Consultation Document)
 
Consultation: An opportunity for comment has been provided on the proposed addition of four medicinal ingredients to Part I of Schedule F to the Food and Drug Regulations.
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult_project_projet_1623-eng.php
 
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/project_projet_1623-eng.php
(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
 
National Interest
 
Federal Government
 
Chemicals Management Plan: On September 26, 2009, the Minister of the Environment and the Minister of Health released a Notice in the Canada Gazette for the eleventh group of substances identified under the Chemicals Management Plan.
http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot_11_e.html
 
GAZETTE I
 
Food and Drug Regulations: Regulations amending the Food and Drug Regulations (1447 — Good Manufacturing Practices) are available.
http://www.gazette.gc.ca/rp-pr/p1/2009/2009-09-26/html/reg2-eng.html
 
Canadian Environmental Protection Act, 1999: Information is available on the eleventh release of technical information relevant to substances identified in the Chemicals Management Plan.
http://www.gazette.gc.ca/rp-pr/p1/2009/2009-09-26/html/index-eng.html
 
Canadian Environmental Protection Act, 1999: The twelfth batch of substances in the Chemicals Management Plan has been identified.
http://www.gazette.gc.ca/rp-pr/p1/2009/2009-09-26/html/index-eng.html
 
Canadian Agency for Drugs and Technologies in Health (CADTH)
 
Report: The Health Technology Assessment Rapid Review report entitled, “Computed Tomography for Pediatric Patients: Review of Clinical Effectiveness and Indications for Use”, is available.
http://www.cadth.ca/index.php/en/hta/reports-publications/search/publication/929

 

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HEADS UP - September 14, 2009

Notices of Compliance - September 8 - 11, 2009

  • Priorix-Tetra (live attenuated measles virus (Schwarz strain); live attenuated mumps virus (RIT4385 strain); live attenuated rubella virus (Wisar RA 27/3 strain); live attenuated varicella virus (OKA strain)) was approved as an active immunizing agent on 2009-09-08.
  •  Cayston (aztreonam), issued under the NOC/c policy, was approved as an antibiotic on 2009-09-11.
 
News from Health Canada
 
Therapeutic Products Directorate (TPD)
 
Consumer Health Advisory
 
Apotex Health Products: Health Canada is informing Canadians that Apotex has voluntarily recalled selected lots of Apo-Amilzide (5-50mg), Apo-Meloxicam (7.5 & 15mg) and Apo-Ranitidine (75 & 150 mg).
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2009/2009_155-eng.php
 
Health Care Professional Advisory
 
PediCap End-Tidal CO2 Detector: There is an urgent voluntary medical device recall regarding the PediCap End-Tidal CO2 Detector (PediCap and PediCap 6).
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2009/pedicap_nth-aah-eng.php
 
Consultation: Health Canada has opened a consultation on the draft guidance entitled, “Keyword Index to Assist Manufacturers in Verifying the Class of In Vitro Diagnotics Devices (IVDD)”.
http://www.hc-sc.gc.ca/dhp-mps/consultation/md-im/consult_draft_md_ivdd_key_ebauche_im_ivid-eng.php
 
http://www.hc-sc.gc.ca/dhp-mps/consultation/md-im/draft_g_md_ivdd_key_ebauche_ld_im_ivid-eng.php
(Consultation Document)
 
Consultation: Health Canada is conducting a consultation on the creation of a regulatory framework for the implementation of Good Manufacturing Practices for active pharmaceutical ingredients.
http://www.hc-sc.gc.ca/dhp-mps/consultation/compli-conform/2009-api-ipa-eng.php
 
http://www.hc-sc.gc.ca/dhp-mps/consultation/compli-conform/2009-api-ipa-lett-eng.php
(Cover Letter)
 
http://www.ich.org/LOB/media/MEDIA433.pdf
(International Conference on Harmonization (ICH) guideline Q7)
 
Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php
 
Meeting: A Record of Proceedings is available for the December 9, 2008 meeting of the Scientific Advisory Committee on Respiratory and Allergy Therapies.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-com/resp_allerg/sacrat_rop_ccstrta_crd_2008-12-09-eng.php
 
National Interest
 
Canadian Agency for Drugs and Technologies in Health (CADTH)
 
Report: The Health Technology Assessment Rapid Review report entitled, “Fecal Immunochemical Tests for Colorectal Cancer Screening: A Systematic Review of Accuracy and Compliance”, is available.
http://www.cadth.ca/media/pdf/M0010_FIT_for_colorectal_cancer_L3_e.pdf
 
Report: The Issues in Emerging Health Technologies report entitled, “Laparoscopic Diaphragm Pacing for Tetraplegia”, is available.
http://www.cadth.ca/media/pdf/R0003_Laparoscopic_Diaphragm_Pacing_Tetraplegia_cetap_e.pdf
 
National Association of Pharmacy Regulatory Authorities (NAPRA)
 
Meeting:  A meeting of the National Drug Scheduling Advisory Committee (NDSAC) was held on September 13-14, 2009 with the following Initial Recommendations made:
 
  • Methocarbamol (except for parenteral use) be retained in Schedule III.
 
  • Diphenhydramine and its salts and preparations (for topical use in concentrations of 2% or less) when sold in containers of 300 mg or less of diphenhydramine hydrochloride – Unscheduled (from Schedule III).
 
Any objections to these Initial Recommendations must be received by the NAPRA office by October 21, 2009.
http://napra.ca/pages/home/default.aspx

 

 

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HEADS UP - September 7, 2009

Notices of Compliance - August 31 - September 4, 2009

  • Doribax (doripenem (supplied as doripenem monohydrate)) was approved as an antibacterial agent on 2009
  • Rasilez HCT (aliskiren (supplied as aliskiren fumarate), hydrochlorothiazide) was approved as a renin inhibitor/diuretic on 2009-09-04.

 News from Health Canada


 Marketed Health Products Directorate (MHPD)
 
Retrospective Document: The document entitled, “Marketed Health Products Directorate: Retrospective - The First Five Years | 2002-2007”, is available.
http://www.hc-sc.gc.ca/ahc-asc/pubs/hpfb-dgpsa/2007-retro-eng.php
 
Biologics and Genetic Therapies Directorate (BGTD)
 
Expert Advisory Committee: The membership list of the Expert Advisory Committee on Cells, Tissues, and Organs (EAC-CTO) has been updated as of April 9, 2009.
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/activit/com/eaccto-ccecto/memb-eng.php
 
Meeting: A record of the April 24, 2008 meeting of the Expert Advisory Committee on Blood Regulation is available.
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/activit/com/eacbr-ccers/_meet-reunion/mm-crr_2008-04-24-eng.php
 
Summary Basis of Decision: A Summary Basis of Decision has been issued for NPLATE.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/sbd_smd_2009_nplate_117327-eng.php
 
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/pm_mp_2009_nplate_117327_partiii-eng.php
(Product Monograph Part III for NPLATE)
 
Therapeutic Products Directorate (TPD)
 
Consumer Health Advisory
 
Cesium Chloride: Health Canada is warning Canadians that the use of stable cesium compounds (non-radioactive form of cesium salts, primarily cesium chloride) may pose the risk of life-threatening heart problems.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2009/2009_153-eng.php
 
Consultation: Health Canada is currently conducting a review of its Good Manufacturing Practices (GMP) inspection program for drug establishments in an effort to make the program more risk-based.
http://www.hc-sc.gc.ca/dhp-mps/consultation/compli-conform/2009gmp-bpf-index-eng.php
 
http://www.hc-sc.gc.ca/dhp-mps/consultation/compli-conform/2009gmp-bpf-book-cahier-eng.php
(Consultation Workbook)
 
Agenda: The Agenda is available for the December 9-10, 2008 meeting of the Scientific Advisory Committee on Respiratory and Allergy Therapies.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-com/resp_allerg/sacrat_a_ccstrta_o_2008-12-09-eng.php
 
Meeting: A Record of Proceedings is available for the August 27, 2008 meeting of the Scientific Advisory Committee on Respiratory and Allergy Therapies (SAC-RAT).
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-com/resp_allerg/sacrat_rop_ccstrta_crd_2008-08-27-eng.php
 
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-com/resp_allerg/sacrat_a_ccstrta_o_2008-08-27-eng.php
(Agenda - Scientific Advisory Committee on Respiratory and Allergy Therapies, August 27, 2008)
 
Summary Basis of Decision: A Summary Basis of Decision has been issued for Zeftera.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/sbd_smd_2009_zeftera_112752-eng.php
 
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/pm_mp_2008_zeftera_112752_partiii-eng.php
(Product Monograph Part III for Zeftera)
 
Register of Innovative Drugs: The Register of Innovative Drugs has been updated.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php
 
National Interest
 
Federal Government: The President of the Treasury Board has tabled the 2009-2010 Supplementary Estimates to obtain the authority of Parliament to adjust the government's expenditure plan.
http://www.tbs-sct.gc.ca/est-pre/20092010/sups-eng.asp
 
Canadian Agency for Drugs and Technologies in Health (CADTH)
 
Report: The Health Technology Assessment Rapid Review Report entitled, “TomoTherapy, Gamma Knife, and CyberKnife Therapies for Patients with Tumours of the Lung, Central Nervous System, or Intra-abdomen: A Systematic Review of Clinical Effectiveness and Cost-Effectiveness”, is available.

http://www.cadth.ca/index.php/en/hta/reports-publications/search/publication/926

 

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Regulatory Notes Archive