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International Pharmaceutical Regulation and Compliance

International Pharmaceutical Regulation and Compliance

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International Pharmaceutical Regulation and Compliance

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  1. International Pharmaceutical Regulation and Compliance Comparisons and Contrasts Lester M. Crawford, PhD

  2. Hegemony of USFDA • The most utilized model • Singapore • South Korea • Taiwan • India

  3. European Medicines Evaluation Agency (EMEA) • A model for a de-centralized state system containing multiple countries

  4. EMEA Governance • Management board—2 EU reps, 1 rep from each member state, 2 reps EU Parliament, 2 patient organization reps, 1 from medical org, 1 from veterinary org.

  5. EMEA Governance • Four scientific committees—Committee on Human Medical Products, Committee on Veterinary Medical Products, Committee on Herbal Medical Products, Committee on Orphan Medical Products

  6. EMEA Expertise and Personnel • An in-house staff of 300+ • A network of 3,000 European experts

  7. EMEA Marketing Authorization • Member state approvals • Centralized procedures • Requirements are identical

  8. US/Singapore Free Trade Agreement • Singapore/US—Medical Products Working Group (MPWG) • Annual Meeting of MPWG • Annual Report to Secretary of HHS and the Minister of Health

  9. Influence of the China Situation • Report of China Institute, University of Alberta • Internal and External Pressures

  10. FDA—Information Sharing Agreements • Japan and Australia • EMEA • Mexico and Canada • Switzerland

  11. FDA—International Agreements • Australia Singapore • Canada Sweden • France Switzerland • Germany South Africa • Ireland United Kingdom • Israel • Japan • Mexico

  12. FDA—International Regulatory Activities • Drug Export Certificates • Drug Imports • Foreign Inspections: 234 preapproval inspections; 213 GMP inspections • Harmonization

  13. Reconciliation of Regulatory Requirements • International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use • World Trade Organization • Organization for Economic Cooperation and Development • The Food Model

  14. The Critical Need to Harmonize • Cost of development • The public health imperative