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