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International Regulatory Agencies Europe   The European Agency for the Evaluation of Medicianal Products (EMEA) European Commission (Eudralex) United States   Food and Drug Administration (FDA) The FDA Center for Biologics Evaluation and Research (CBER) Canada   Health Canada - Federal Department of Health Australia   Therapeutic Goods Administration, Department of Health and Aging, Australia Government New Zealand   MedSafe - New Zealand Medicines and Medical Devices Safety Authority, a business unit of the Ministry of Health South Africa   Medicines Control Council, Department of Health Japan   Ministry of Health, Labour and Welfare The Organization for Pharmaceutical Safety and Research (OPSR/Kiko) Back to top International Sites Canada Health, Therapeutic Products Directorate Commission of the European Communities The European Agency for the Evaluation of Medicinal Products European Compilation of Procedures for GMP Inspections European Directorate for the Quality of Medicines European Federation of Pharmaceutical Industries and Federations European Guide to GMP European Guide to GMP - updates etc European Guidelines on Quality, Safety and Efficacy European Pharmacopoeia: Mutual Recognition Agreements Status International Conference on Harmonisation International Society of Pharmaceutical Engineers International Pharmaceutical Federation International Pharmaceutical Excipients Council Meningitis Vaccine Project Japanese Ministry of Health, Labour and Welfare Mutual Recognition Agreements Therapeutic Goods Administration, Australian Regulatory Agency UK Official Documents including the "Orange Guide" and Medicines Legislation The UK Medicines Control Agency World Health Organisation GMP Information World Health Organization (WHO) Back to top International Conference on Harmonisation (ICH) Related Sites ICH Home Page ICH Guidelines at the IFPMA Site Regulatory Affairs and Resource Sites Regulatory Affairs Information HomePage Regulatory Affairs Professionals Society (RAPS) Canada Health, Therapeutic Products Directorate Back to top United States Regulations and Regulatory Bodies Office of Regulatory Affairs (ORA) FDA GMP Regulations (CFR21) FDA - Inspections Operation Manual Inspection Guides FDA FDA human drugs GMP notes FDA CBER Guidance / Guidelines / Points to Consider The FDA Center for Drug Evaluation and Research (CDER) The FDA Center for Devices and Radiological Health (CDRH) The FDA Center for Food Safety & Applied Nutrition (CFSAN) The FDA Center for Veterinary Medicine (CVM) The Code of Federal Regulations (CFR) Recent FDA News Freedom of Information Reading Room (FOI) FDA Advisory Committee Food and Drug Adminsitration Alumni Association Back to top Related Industrial and Professional Medical Societies Association of American Medical Colleges Asthma and Allergy Foundation of America (AAFA) Regulatory Affairs Professionals Society (RAPS) International Federation of Pharmceutical Manufacturers Associations (IFPMA) Meningitis Vaccine Project Pharmaceutical Research and Manufacturers of America (PhRMA) Pharmaceutical Inspection Co-operation Scheme (GMP Guide and basic standards) Parenteral Drug Association (PDA) Biotechnology Industry Organization (BIO) The Food and Drug Law Institute (FDLI) National Foundation for Infectious Diseases National Organization for Rare Disorders (NORD) United States Pharmacopoeia USP-NF Back to top Scientific Journals on the Web Biolinks (Articles are priced individually) BioMed Central (Free access to articles posted) Blood Cells, Molecules and Diseases British Medical Journal British Pharmacopoeia Doctor's Guide Journal Directory (Articles are priced individually) Free Medical Journals (Free access to articles posted) HighWire (Free access to articles posted) Journal of Biotechnology Journal of Infectious Diseases Journal of Virology Journal of Molecular Biology Journal of the National Cancer Institute MedWorld Bio (Can purchase subscriptions for online biojournals) The New England Journal of Medicine Nature Immunology United States Pharmacopoeia USP-NF Back to top Life Science & Medical Sites American Medical Association (AMA) Center for Human Simulation Development of Polio Vaccines (Access Excellance) DNA Vaccine Information Site Epidemic! The World of Infectious Disease (American Museum of Natural History) Molecular Expressions (Exploring the World of Optics & Microscopy) Vaccines(Access Excellance) The Vaccine Page (Vaccine Database and Vaccine News) The Virtual Cell The Visible Human Project Back to top