Useful Regulatory Links

Asia Pacific

Health Sciences Authority (HSA)

World Health Organisation (WHO)

Australia:

Australian Therapeutics Goods Administration (TGA) Home page

Agricultural and veterinary chemicals

Singapore:

Medicines Control Council

New Zealand:

Medsafe

Australia:

Australian Therapeutics Goods Administration (TGA) Home page

Agricultural and veterinary chemicals

Europe:

Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme

United States:

FDA Home page

Code of Federal Regulations

Other General Links:

American Association of Pharmaceutical Sciences (AAPS)
 

British Pharmacopoeia (BP)

Drug Information Association (DIA)

European Medicines Agency (EMEA)
European Pharmacopoeia (EP)
European Federation of Pharmaceutical Industries and Associations (EFPIA)
European Generic Medicines Association (EGA)
EU Heads of Agencies (HoA)

Food and Drug Administration, USA (FDA) - CDER
FDA Guidance documents
FDA inspection guides
FDA warning letters

Heads of European Veterinary Regulatory Authorities (HEVRA)
Health on the net foundation

International Conference on Harmonisation (ICH)
International Federation for Animal Health (IFAH)
International Society of Pharmaceutical Engineers (ISPE)

National Institutes of Health, USA (NIH)
National Library of Medicine

PDA (An International Association for Pharmaceutical Science and Technology)
Pharmaceutical Research and Manufacturers of America (PhRMA)
Pharmaceutical Technology
Pharmweb (FIP, ICH, IPEC, Pharmaceutical Quality Group)

United States Pharmacopoeia (USP)

World Health Organization (WHO)

 

 
Validation Master Plans

Software options / review

Looking for Pharmaceutical Software?

Extensive list of pharmaceutical software options summarised for your convenience. LIMS, CAPA, Change Control, CMMS, Sarbanes-Oxley etc software options?

 

 

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