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International Pharmaceutical Regulation and Compliance

International Pharmaceutical Regulation and Compliance. Comparisons and Contrasts Lester M. Crawford, PhD. Hegemony of USFDA. The most utilized model Singapore South Korea Taiwan India. European Medicines Evaluation Agency (EMEA).

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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

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