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Health Products and Food Branch Direction générale des produits de santé et des aliments Overview of the Canadian Federal Drug Review Process Pharmaceutical.

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Presentation on theme: "Health Products and Food Branch Direction générale des produits de santé et des aliments Overview of the Canadian Federal Drug Review Process Pharmaceutical."— Presentation transcript:

1 Health Products and Food Branch Direction générale des produits de santé et des aliments Overview of the Canadian Federal Drug Review Process Pharmaceutical Marketing Club of Quebec Education Day Seminar Micheline Ho Therapeutic Products Directorate October 19, 2004

2 Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments 2 Responsibilities for Drugs % Federal Regulates the safety, efficacy and quality of drugs Ensures patent linkage (Health Products & Foods Branch) Controls the price of patented medicines (Patented Medicines Prices Review Board) Coordination and leadership on FPT pharmaceutical issues % Provincial Delivery of healthcare Practice of Medicine/Pharmacy Reimbursement issues Drug Formularies

3 Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments 3 Federal Legislation and Guidance for Drugs Food and Drugs Act and Regulations Governs the safety, effectiveness and quality of drugs and medical devices available to Canadians. % Patented Medicines (NOC) linkage Regulation % Financial Administration Act (fees for review-cost recovery) % Access to Information and Privacy Act % Controlled Drugs and Substances Act (governs narcotic & controlled drugs) % Policies and Guidelines (including International Guidelines - ICH) in support of the Acts and Regulations

4 Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments 4 Health Canada

5 Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments 5 Health Products and Food Branch

6 Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments 6 Therapeutic Products Directorate Effective April 1, 2002 Therapeutic Products Directorate

7 Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments 7 Health Products and Food Branch (HPFB) Responsibilities for Drugs % Therapeutic Products Directorate (TPD) Responsible for evaluating the safety, effectiveness and quality of pharmaceutical drugs and medical devices available to Canadians. o Similar to CDER in U.S. – F.D.A. Biologics and Genetic Therapies Directorate (BGTD) Responsible for evaluating the safety, effectiveness and quality of biological and radiopharmaceutical drugs, as well as blood and blood products, viral and bacterial vaccines, genetic therapeutic products, tissues, organs and xenografts. o Similar to CBER in U.S. – F.D.A.

8 Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments 8 Health Products and Food Branch (HPFB) Responsibilities for Human Drugs - contd % HPFB Inspectorate – Compliance & Enforcement n Responsible for delivery of inspections and investigations, and for most establishment licensing and related laboratory analysis functions. % Marketed Health Products Directorate (MHPD) n Responsible for post-market assessment and surveillance of pharmaceutical and biological drugs, medical devices, natural health products, radio- pharmaceuticals.

9 Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments 9 Product Types Regulated as Drugs Pharmaceuticals (prescription, non-prescription, brand name, generic) Biological drugs (vaccines, recombinant drugs, blood products) Radiopharmaceuticals Natural Health Products Homeopathic products Traditional herbal medicines Other Herbals Disinfectants for use on medical instruments, hospital and food preparation surfaces Veterinary Drugs

10 Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments 10 Life of a New Drug Research Create/Isolate Chemicals Tissue/Culture More Specific animal (14,000 tested to get one as marketable) small animals testing and in vitro tests (e.g. carcinogenicity, reproductive studies) Human Testing Special Access Program (SAP) (Clinical Trial) (emergency release) HC approval required (Food & Drug Act & Regulations 30 day default) Post Market Surveillance Provincial Formulary Decisions All testing is done, drug company completes analysis of data, prepares New Drug PMPRB Submission (NDS) (price controls) HC Review Decision

11 Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments 11 Drugs Sold in Canada % All drugs sold in Canada must be approved by Health Canada. These include but are not limited to the following: drugs imported from other countries; drugs manufactured in Canada; Division 8 / C.01.014 (DIN) New drug

12 Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments 12 New Drug Approval Process

13 Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments 13 Submission Processing – more details

14 Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments 14 Priority Review %... for a drug submission for a serious, life threatening or severely debilitating disease or condition for which there is substantial clinical evidence that the drug provides: % effective treatment/prevention/diagnosis of a disease or condition for which no drug is presently marketed in Canada… http://www.hc-sc.gc.ca/hpb-dgps/therapeut/zfiles/english/policy/issued/prirevw_e. pdf

15 Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments 15 Performance Targets % The type of data package (safety, efficacy, quality) submitted and whether or not it is accepted for priority review determines the performance target Examples: % Processing- 10 days* % Screening - 45 days* % NDS – Review : priority - 180 days* non-priority - 300 days* % ANDS - Review : - 180 days* * Calendar days

16 Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments 16 Performance Reporting % Drug submission performance is reported quarterly and annually % Reports are posted on our website: http://www.hc-sc.gc.ca/hpb-dgps/therapeut/htmleng/drug_submission_reports

17 Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments 17 Drug Identification Numbers (DINs) and Notices of Compliance (NOC) DINS are issued to all drugs approved for marketing in Canada. (8 digit number generated by DPD) Must appear on the label Notification of first sale NOC are issued to all new drugs that are approved.

18 Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments 18 DIN / NOC / NOC-C % NOC n NOC Letter n Product Monograph n Labels % NOC-C n NOC Letter n Product Monograph n Labels n Letter of Undertaking % DINA n Authorized labels n Prescribing Information

19 Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments 19 NOC-C % For: n Serious, life-threatening n Severely debilitating conditions, or n Significant improvement in efficacy n Significant decrease in side-effects when no marketed treatment to adequately manage the condition

20 Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments 20 NOC-C (continued) % May provide earlier access % Physicians and patients to be aware % Letter of Undertaking n Clinical studies n ADR monitoring n Distribution / Advertising conditions n Pre-clearance by PAAB

21 Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments 21 Therapeutic Access Strategy (TAS) Key Business Transformation Strategy Speech from the Throne - 2002 As part of its focus on Smart Regulation, the government …. (will) speed up the regulatory process for drug approvals to ensure Canadians have faster access to the safe drugs they need. Budget - 2003 Provide $190 million over 5 years to improve the timeliness of Health Canadas regulatory processes with respect to human drugs – while preserving the principle that safety is of paramount concern.

22 Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments 22 Health Canadas Response: The Therapeutics Access Strategy In the near term, improve regulatory performance around timeliness and transparency, benchmarked against leading international practices

23 Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments 23 The Initiatives Project Management Good Review Practices International Cooperation Transparency E-Review Regulatory Policy Expert Advisory Capacity

24 Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments 24 Post Market Roles and Activities % Role n Legislated responsibilities, Duty of Care regarding safety of new drugs % Activities n Monitor and collect adverse drug reaction and medication incident data and communicate these to health professionals and public (e.g. Advisories for therapeutic products, Canadian Adverse Drug Reaction Newsletter, Health_Prod_Info) n Review and analyze safety data n Conduct risk/benefit assessments of marketed products n Overview of regulatory advertising activities

25 Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments 25 Strengthening Post-Market Safety of New Drugs Measures will include: n Moving from reactive to proactive and preventative measures n Expanding network of Regional Adverse Reaction Centers n Launching investigations and requiring manufacturers to conduct post-approval clinical trials n More timely and accurate advice to health care professionals and the public Outcomes: n Will reduce risks to Canadians from preventable adverse drug events

26 Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments 26 International Harmonization % HPFB has been very active in helping develop and implement international standards for the registration of new drugs. HPFB has contributed significantly to the development of over 45 harmonized technical guidelines. Canada is the only observer country to the International Conference on Harmonization (ICH) and is committed to implementing finalized ICH guidelines and standards including the Common Technical Document (CTD).

27 Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments 27 Drug Submissions Received Annually (approx.) (TPD & BGTD) Total: 4,400 per year % 80 – NDS (New Drug Submission) 35 for new active substances % 170 – SNDS (Supplement to NDS) % 80 – ANDS (Abbreviated New Drug Submission) % 10 – SANDS (Supplement to ANDS) % 800 – NC (Notifiable Change)

28 Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments 28 Drug Submissions Received Annually (approx.) (TPD & BGTD) – contd % 1700 – DINA (Drug Identification Number Application) % 360 – Administrative Change Submissions Change in manufacturers name and/or product name; cross-reference submissions % 1200 – Clinical Trial Applications (previously INDs – Investigational New Drug Submissions)

29 Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments 29 Drugs Marketed in Canada % 22,000 (approx.) Human Drug Products n 6,000 Prescription n 9,000 Non-Prescription n 6,000 Homeopathics n 1,000 Controlled Drugs, Narcotics & Biologics % 1,450 (approx.) Veterinary Drug Products

30 Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments 30 TPD Websites / Contact Points TPD Main Website: www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/index_e.html SIPD – Marketing Status (Drug Product Database [DPD]): www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/index_drugs_dpd_e.html NOC Database: www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/index_drugs_noc_e.html Food and Drugs Act and Regulations www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/index_drugs_regulations_e.html Guidance Documents, Policies, Templates, Forms: www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/index_drugs_information_e.html Specific Product Information – RPMs

31 Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments 31 Continuous Balancing Act % Drug submission review performance is impacted by the many other issues and challenges which we strive to keep in balance: o advancements in science and technology o timeliness vs. ensuring safety / efficacy o adhering to strict regulations/policies and being flexible and reasonable o participating in an international community while respecting our domestic environment

32 Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments 32 Lexicon ADRAdverse Drug Reaction ANDSAbbreviated New Drug Submission BGTDBiologic and Genetic Therapies Directorate CDER Center for Drug Evaluation & Research DIN Drug Identification Number (an 8-digit number that all drugs in Canada must have) DINADrug Identification Number Application DPDDrug Product Database FDAUnited States Food and Drug Administration

33 Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments 33 Lexicon- contd FPTFederal / Provincial / Territorial ICHInternational Conference on Harmonization INDInvestigational New Drug Submission MHPDMarketed Health Products Directorate NCNotifiable Change NDSNew Drug Submission NOC Notice of Compliance (an approval letter to market a product in Canada) NOC-CNotice of Compliance with Conditions

34 Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments 34 Lexicon - contd RPMRegulatory Project Manager SRPMSenior Regulatory Project Manager PMProduct Monograph SANDSSupplemental Abbreviated New Drug Submission SIPDSubmission Information Policy Division SNDSSupplemental New Drug Submission TASTherapeutic Access Strategy


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