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Useful Links

We have provided some links that we hope you will find useful. Please revisit this site from time to time as we update it as new sites become available.

USA
Food and Drug Administration (FDA) Home Page

FDA - Center for Biologics Evaluation and Research 

FDA - Center for Devices and Radiological Health

FDA - Center 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

UK
European Pharmacopoeia (EDQM)

Medicines and Healthcare Products Regulatory Agency (MHRA)

National Institute for Biological Standards and Control

UK Statutory Instruments

Pharmaceutical Inspection Co-operation Scheme
PICS



 

Europe
European Medicines Agency (EMEA)

Official Journal of the European Union (OJ)

Quality Working Party Guidelines - for EU Marketing Authorisation Applications

EMEA Inspections Homepage

EU Inspectorates - What's New

GMP Sector of the EMEA Site


International Conference On Harmonisation
International Conference on Harmonisation (ICH) Home Page


(WHO) - World Health Organisation
WHO

Pharmacopoeias
US Pharmacopoeia

European Pharmacopoeia (EDQM)

British Pharmacopoeia

Australia
Therapeutic Goods Administration

Other

AAPS

Medline

USPTO