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