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Micheline Ho Therapeutic Products Directorate October 19, 2004

Overview of the Canadian Federal Drug Review Process Pharmaceutical Marketing Club of Quebec Education Day Seminar. Micheline Ho Therapeutic Products Directorate October 19, 2004. Responsibilities for Drugs. Federal Regulates the safety, efficacy and quality of drugs Ensures patent linkage

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Micheline Ho Therapeutic Products Directorate October 19, 2004

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  1. Overview of the Canadian Federal Drug Review ProcessPharmaceutical Marketing Club of QuebecEducation Day Seminar Micheline Ho Therapeutic Products Directorate October 19, 2004

  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. 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 Canada

  5. Health Products and Food Branch

  6. Therapeutic Products Directorate Therapeutic Products Directorate Effective April 1, 2002

  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. • 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. • Similar to CBER in U.S. – F.D.A.

  8. Health Products and Food Branch (HPFB) Responsibilities for Human Drugs - cont’d • HPFB Inspectorate – Compliance & Enforcement • Responsible for delivery of inspections and investigations, and for most establishment licensing and related laboratory analysis functions. • Marketed Health Products Directorate (MHPD) • Responsible for post-market assessment and surveillance of pharmaceutical and biological drugs, medical devices, natural health products, radio-pharmaceuticals.

  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. 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. 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. New Drug Approval Process

  13. Submission Processing – more details

  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. 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. 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. 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. DIN / NOC / NOC-C • NOC • NOC Letter • Product Monograph • Labels • NOC-C • NOC Letter • Product Monograph • Labels • Letter of Undertaking • DINA • Authorized labels • Prescribing Information

  19. NOC-C • For: • Serious, life-threatening • Severely debilitating conditions, or • Significant improvement in efficacy • Significant decrease in side-effects when no marketed treatment to adequately manage the condition

  20. NOC-C (continued) • May provide earlier access • Physicians and patients to be aware • Letter of Undertaking • Clinical studies • ADR monitoring • Distribution / Advertising conditions • Pre-clearance by PAAB

  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 Canada’s regulatory processes with respect to human drugs – while preserving the principle that safety is of paramount concern.”

  22. Health Canada’s Response:The Therapeutics Access Strategy In the near term, improve regulatory performance around timeliness and transparency, benchmarked against leading international practices

  23. The Initiatives • Project Management • Good Review Practices • International Cooperation • Transparency • E-Review • Regulatory Policy • Expert Advisory Capacity

  24. Post Market Roles and Activities • Role • Legislated responsibilities, ‘Duty of Care’ regarding safety of new drugs • Activities • 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) • Review and analyze safety data • Conduct risk/benefit assessments of marketed products • Overview of regulatory advertising activities

  25. Strengthening Post-Market Safety of New Drugs Measures will include: • Moving from reactive to proactive and preventative measures • Expanding network of Regional Adverse Reaction Centers • Launching investigations and requiring manufacturers to conduct post-approval clinical trials • More timely and accurate advice to health care professionals and the public Outcomes: • Will reduce risks to Canadians from preventable adverse drug events

  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. 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. Drug Submissions Received Annually (approx.) (TPD & BGTD) – cont’d • 1700 – DINA(Drug Identification Number Application) • 360 – Administrative Change Submissions • Change in manufacturer’s name and/or product name; cross-reference submissions • 1200 – Clinical Trial Applications(previously INDs – Investigational New Drug Submissions)

  29. Drugs Marketed in Canada • 22,000 (approx.) Human Drug Products • 6,000 Prescription • 9,000 Non-Prescription • 6,000 Homeopathics • 1,000 Controlled Drugs, Narcotics & Biologics • 1,450 (approx.) Veterinary Drug Products

  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 – RPM’s

  31. Continuous Balancing Act • Drug submission review performanceis impacted by the many other issues and challenges which we strive to keep in balance: • advancements in science and technology • timeliness vs. ensuring safety / efficacy • adhering to strict regulations/policies and being flexible and reasonable • participating in an international community while respecting our domestic environment

  32. Lexicon ADR Adverse Drug Reaction ANDS Abbreviated New Drug Submission BGTD Biologic 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) DINA Drug Identification Number Application DPD Drug Product Database FDA United States Food and Drug Administration

  33. Lexicon- cont’d FPT Federal / Provincial / Territorial ICH International Conference on Harmonization IND Investigational New Drug Submission MHPD Marketed Health Products Directorate NC Notifiable Change NDS New Drug Submission NOC Notice of Compliance(an approval letter to market a product in Canada) NOC-C Notice of Compliance with Conditions

  34. Lexicon - cont’d RPM Regulatory Project Manager SRPM Senior Regulatory Project Manager PM Product Monograph SANDS Supplemental Abbreviated New Drug Submission SIPD Submission Information Policy Division SNDS Supplemental New Drug Submission TAS Therapeutic Access Strategy

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