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TGA_PMDA_HealthCanada_Org_Structure_PPT.pptx
- 1. Organizational Structure ofTGA, PMDA & Health Canada (HPFB)
- 2. Introduction to TGA •TGA is Australia’s regulatory authority for therapeutic goods. • Functions under the Department of Health and Aged Care. • Ensures safety, efficacy, and quality of medicines, medical devices, and biologicals.
- 3. Parent Organization (TGA) •Department of Health and Aged Care • - Oversees national health policy and regulatory bodies. • - TGA is part of the Health Products Regulation Group (HPRG).
- 4. Top-Level Structure ofTGA • Department of Health and Aged Care • ↓ • Health Products Regulation Group (HPRG) • ↓ • Therapeutic Goods Administration (TGA)
- 5. Key Leadership (TGA) •National Manager – TGA • - Heads the organization. • - Reports to Deputy Secretary of HPRG.
- 6. Core Divisions ofTGA • Market Authorisation Group – Evaluates applications for new drugs and devices • Monitoring & Compliance – Conducts inspections, post-market surveillance • Regulatory Support – Legal, IT, policy, and stakeholder functions
- 7. Scientific and RegulatoryUnits (TGA) • Office of Chief Scientist • Medicines Regulation Division • Medical Devices & Product Quality Division • Office of Manufacturing Quality (GMP Inspections)
- 8. Key IT andLegal Support Units (TGA) • Regulatory Legal Services • Risk Management & Evaluation • IT & Business Systems (eBS Portal)
- 9. Systems Managed byTGA • ARTG: Australian Register of Therapeutic Goods • DAEN: Database of Adverse Event Notifications • eBS: eBusiness Portal for submissions and tracking
- 10. Visual Summary (TGA) •Department of Health & Aged Care • ↓ • Health Products Regulation Group • ↓ • Therapeutic Goods Administration • └─ Market Authorisation • └─ Monitoring & Compliance • └─ Regulatory Support
- 11. Introduction to PMDA(Japan) • PMDA: Pharmaceuticals and Medical Devices Agency • Functions under the Ministry of Health, Labour and Welfare (MHLW) • Regulates pharmaceuticals, biologics, and medical devices • Responsible for pre- and post-market safety, clinical trials, and relief compensation
- 12. Structure of PMDA •Ministry of Health, Labour and Welfare (MHLW) • ↓ • Pharmaceuticals and Medical Devices Agency (PMDA) • ─ ├ Office of New Drug Review • ─ ├ Office of Medical Device Evaluation • ─ ├ Office of Safety (Pharmacovigilance) • ─ ├ Relief Services Division
- 13. Key Responsibilities ofPMDA • Evaluate new drug and generic applications (NDA) • Review medical devices and biologics • Ensure GCP and GMP compliance • Monitor post-market safety via J-ADR system • Provide relief compensation for ADR-related injuries • Offer scientific advice to manufacturers
- 14. PMDA Regulatory Applications •NDA – New drug approvals • Generic Drug Approval – Based on bioequivalence and quality data • Medical Device Review – Evaluation of safety and efficacy • Clinical Trial Notification (CTN) – To begin human clinical trials in Japan
- 15. PMDA Global Roleand Systems • Member of ICH and PIC/S • Collaborates with USFDA, EMA, TGA, CDSCO • Uses J-ADR for adverse drug event reporting • Coordinates with MHLW for final regulatory decisions
- 16. Introduction to HealthCanada • Health Canada is the federal department responsible for helping Canadians maintain and improve their health. • The Health Products and Food Branch (HPFB) is the main regulatory authority for therapeutic products. • Ensures safety, efficacy, and quality of drugs, biologics, and medical devices.
- 17. Structure of HealthCanada (HPFB) • Health Canada • ↓ • Health Products and Food Branch (HPFB) • ─ ├ Therapeutic Products Directorate (TPD) • ─ ├ Biologics and Radiopharmaceuticals Directorate (BRDD) • ─ ├ Marketed Health Products Directorate (MHPD) • ─ ├ Medical Devices Directorate (MDD)
- 18. Key Responsibilities ofHealth Canada • Review and approval of prescription and non- prescription drugs • Regulation of biologics and radiopharmaceuticals • Market surveillance and post-marketing safety (MHPD) • Regulation of medical devices and natural health products
- 19. Regulatory Systems andGlobal Role • Member of ICH and PIC/S • Uses the Drug Product Database (DPD) and Clinical Trials Database • Collaborates with USFDA, EMA, TGA, PMDA • Issues Notice of Compliance (NOC) and Drug Identification Number (DIN)
- 20. Conclusion • TGA, PMDA,and Health Canada are central to drug/device regulation in their countries • They ensure public health through rigorous safety and efficacy standards • Collaboration and harmonization with global agencies improve global drug access
- 21. References • https://www.tga.gov.au • https://www.health.gov.au •https://www.pmda.go.jp/english • https://www.mhlw.go.jp • https://www.canada.ca/en/health-canada