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Useful Links to Regulatory Agencies

UK MHRA logo
Medicines and Healthcare products Regulatory Agency (MHRA)

MHRA Medicines Directorate

     Click here for a link to the UK (MHRA) Defective Medicines Reporting Centre

MHRA Devices Directorate
Veterinary Medicines Directorate (DEFRA)
UK Acts of Parliament eg Medicines Act 1968
UK Statutory Instruments (these amend UK Acts)

European Medicines Agency (EMA)

European Medicines Agency (EMA)
Eudralex Rules Governing Medicinal Products In The EU

Eudralex Volume 4 – GMP Guide

Official Journal of the European Union (OJ)
Quality Working Party Guidelines - for EU Marketing Authorisation Applications
EMA Inspections Homepage
EU Inspectorates - What's New
EU Compilation of Community Procedures on Inspections and Exchange of Information

EU Product Defect and Recall Procedures


       Click here for a link to the UK (MHRA) Defective Medicines Reporting Centre

USA U.S. Food and Drug Administration
Food and Drug Administration (FDA) Home Page

FDA - Centre for Biologics Evaluation and Research

FDA - Centre for Drug Evaluation and Research

FDA - Codes of Federal Regulations

FDA - Inspection References: Index
FDA - Inspection Guides
FDA - Guidance Documents: Index
JAPAN Ministry of Health, Labour and Welfare
Ministry of Health, Labour and Welfare
PMDA - Pharmaceuticals and Medical Devices Agency
PMDA webpage on Japanese GMPs and Product Applications
Japan Pharmaceutical Manufacturers Association
JPMA webpage covering Japanese Laws (PAL - Pharmaceutical Affairs Law)
Japanese Pharmacopoeia
International Conference on Harmonisation (ICH) Home Page

ICH Quality Guidelines



Pharmaceutical Inspection Co-operation Scheme

Pharmaceutical Inspection Co-operation Scheme
PIC/S Guidelines
PIC/S Recommendations
WHO WHO logo
World Health Organisation
US Pharmacopoeia

European Pharmacopoeia (EDQM)

Japanese Pharmacopoeia
British Pharmacopoeia