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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 Comparisons and Contrasts Lester M. Crawford, PhD
Hegemony of USFDA • The most utilized model • Singapore • South Korea • Taiwan • India
European Medicines Evaluation Agency (EMEA) • A model for a de-centralized state system containing multiple countries
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.
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
EMEA Expertise and Personnel • An in-house staff of 300+ • A network of 3,000 European experts
EMEA Marketing Authorization • Member state approvals • Centralized procedures • Requirements are identical
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
Influence of the China Situation • Report of China Institute, University of Alberta • Internal and External Pressures
FDA—Information Sharing Agreements • Japan and Australia • EMEA • Mexico and Canada • Switzerland
FDA—International Agreements • Australia Singapore • Canada Sweden • France Switzerland • Germany South Africa • Ireland United Kingdom • Israel • Japan • Mexico
FDA—International Regulatory Activities • Drug Export Certificates • Drug Imports • Foreign Inspections: 234 preapproval inspections; 213 GMP inspections • Harmonization
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
The Critical Need to Harmonize • Cost of development • The public health imperative