Presentation on theme: "Micheline Ho Therapeutic Products Directorate October 19, 2004"— Presentation transcript:
1Micheline Ho Therapeutic Products Directorate October 19, 2004 Overview of the Canadian Federal Drug Review Process Pharmaceutical Marketing Club of Quebec Education Day SeminarMicheline HoTherapeutic Products DirectorateOctober 19, 2004
2Responsibilities for Drugs FederalRegulates the safety, efficacy and quality of drugsEnsures patent linkage(Health Products & Foods Branch)Controls the price of patented medicines(Patented Medicines Prices Review Board)Coordination and leadership on FPT pharmaceutical issuesProvincialDelivery of healthcarePractice of Medicine/PharmacyReimbursement issuesDrug Formularies
3Federal Legislation and Guidance for Drugs Food and Drugs Act and RegulationsGoverns the safety, effectiveness and quality of drugs and medical devices available to Canadians.Patented Medicines (NOC) linkage RegulationFinancial Administration Act (fees for review-cost recovery)Access to Information and Privacy ActControlled Drugs and Substances Act(governs narcotic & controlled drugs)Policies and Guidelines (including International Guidelines - ICH) in support of the Acts and Regulations
6Therapeutic Products Directorate Effective April 1, 2002
7Health 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.
8Health Products and Food Branch (HPFB) Responsibilities for Human Drugs - cont’d HPFB Inspectorate – Compliance & EnforcementResponsible 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.
9Product Types Regulated as “Drugs” Pharmaceuticals (prescription, non-prescription, brand name, generic)Biological drugs (vaccines, recombinant drugs, blood products)RadiopharmaceuticalsNatural Health ProductsHomeopathic productsTraditional herbal medicinesOther HerbalsDisinfectants for use on medical instruments, hospital and food preparation surfacesVeterinary Drugs
10Life 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 TestingSpecial Access Program (SAP) (Clinical Trial)(emergency release)HC approval required(Food & Drug Act & Regulations 30 day default) Post Market SurveillanceProvincial Formulary Decisions All testing is done, drug company completes analysis of data, prepares New DrugPMPRB Submission (NDS)(price controls) HC Review Decision
11Drugs Sold in CanadaAll 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 (DIN)New drug
14Priority 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…pdf
15Performance TargetsThe type of data package (safety, efficacy, quality) submitted and whether or not it is accepted for priority review determines the performance targetExamples:Processing days*Screening days*NDS – Review : priority days*non-priority days*ANDS - Review : days** Calendar days
16Performance Reporting Drug submission performance is reported quarterly and annuallyReports are posted on our website:
17Drug 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 labelNotification of first saleNOC are issued to all new drugs that are approved.
18DIN / NOC / NOC-C DINA Authorized labels Prescribing Information NOC NOC LetterProduct MonographLabelsNOC-CNOC LetterProduct MonographLabelsLetter of Undertaking
19NOC-CFor:Serious, life-threateningSeverely debilitating conditions, orSignificant improvement in efficacySignificant decrease in side-effectswhen no marketed treatment to adequately manage the condition
20NOC-C (continued) May provide earlier access Physicians and patients to be awareLetter of UndertakingClinical studiesADR monitoringDistribution / Advertising conditionsPre-clearance by PAAB
21Therapeutic Access Strategy (TAS) Key Business Transformation StrategySpeech from the ThroneAs 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.”BudgetProvide $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.”
22Health Canada’s Response: The Therapeutics Access Strategy In the near term, improve regulatoryperformance around timeliness andtransparency, benchmarked againstleading international practices
23The Initiatives Project Management Good Review Practices International CooperationTransparencyE-ReviewRegulatory PolicyExpert Advisory Capacity
24Post Market Roles and Activities Legislated responsibilities, ‘Duty of Care’ regarding safety of new drugsActivitiesMonitor 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 dataConduct risk/benefit assessments of marketed productsOverview of regulatory advertising activities
25Strengthening Post-Market Safety of New Drugs Measures will include:Moving from reactive to proactive and preventative measuresExpanding network of Regional Adverse Reaction CentersLaunching investigations and requiring manufacturers to conduct post-approval clinical trialsMore timely and accurate advice to health care professionals and the publicOutcomes:Will reduce risks to Canadians from preventable adverse drug events
26International 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).
27Drug Submissions Received Annually (approx.) (TPD & BGTD) Total: 4,400 per year80 – NDS (New Drug Submission)35 for new active substances170 – SNDS (Supplement to NDS)80 – ANDS (Abbreviated New Drug Submission)10 – SANDS (Supplement to ANDS)800 – NC (Notifiable Change)
28Drug Submissions Received Annually (approx.) (TPD & BGTD) – cont’d 1700 – DINA (Drug Identification Number Application)360 – Administrative Change SubmissionsChange in manufacturer’s name and/or product name; cross-reference submissions1200 – Clinical Trial Applications (previously INDs – Investigational New Drug Submissions)
29Drugs Marketed in Canada 22,000 (approx.) Human Drug Products6,000 Prescription9,000 Non-Prescription6,000 Homeopathics1,000 Controlled Drugs, Narcotics & Biologics1,450 (approx.) Veterinary Drug Products
30TPD Websites / Contact Points TPD Main Website:SIPD – Marketing Status (Drug Product Database [DPD]):NOC Database:Food and Drugs Act and RegulationsGuidance Documents, Policies, Templates, Forms:Specific Product Information – RPM’s
31Continuous Balancing Act Drug submission review performance is impacted by the many other issues and challenges which we strive to keep in balance:advancements in science and technologytimeliness vs. ensuring safety / efficacyadhering to strict regulations/policies and being flexible and reasonableparticipating in an international community while respecting our domestic environment
32Lexicon ADR Adverse Drug Reaction ANDS Abbreviated New Drug Submission BGTD Biologic and Genetic TherapiesDirectorateCDER Center for Drug Evaluation & ResearchDIN Drug Identification Number (an 8-digit number that all drugs in Canada must have)DINA Drug Identification Number ApplicationDPD Drug Product DatabaseFDA United States Food and DrugAdministration
33Lexicon- cont’d FPT Federal / Provincial / Territorial ICH International Conference onHarmonizationIND Investigational New Drug SubmissionMHPD Marketed Health Products DirectorateNC Notifiable ChangeNDS New Drug SubmissionNOC Notice of Compliance (an approval letter to market a product in Canada)NOC-C Notice of Compliance with Conditions
34Lexicon - cont’d RPM Regulatory Project Manager SRPM Senior Regulatory Project ManagerPM Product MonographSANDS Supplemental Abbreviated New DrugSubmissionSIPD Submission Information Policy DivisionSNDS Supplemental New Drug SubmissionTAS Therapeutic Access Strategy