UK


Medicines and Healthcare products Regulatory Agency (MHRA)

MHRA Medicines Section

MHRA Medicines Section - MAIL

MHRA Medicines Section - Recalls/DMRC

MHRA Medical Devices Section

Veterinary Medicines Directorate (DEFRA)

National Institute for Biological Standards and Control

UK Statutory Instruments


USA


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

FDA - Warning Letters - General Searches


Pharmaceutical Inspection Co-operation Scheme


PICS


Australia


Therapeutic Goods Administration


Jargon Buster


Jargon Buster Document


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Europe


European Medicines Agency (EMEA)

"Eudralex" Rules Governing Medicinal Products In The EU

Quality Working Party Guidelines - for EU Marketing Authorisation Applications

EMEA Inspections Homepage

EU Inspectorates - What's New

GMP Sector of the EMEA Site


Qualified Person


Guidance Notes to Assist the QP

Royal Society of Chemistry

Institute of Biology

Royal Pharmaceutical Society of Great Britain


International Conference On Harmonisation


International Conference on Harmonisation (ICH) Home Page


(WHO) - World Health Organisation


WHO


Pharmacopoeias


US Pharmacopoeia

European Pharmacopoeia (EDQM)

British Pharmacopoeia


Risk Assessment


Risk Assessment