Medicine Regulation Links
Food and Drug AdministrationPrescription Drug User Fee Act (PDUFA) Reports and Plans
United States - Food, Drug and Cosmetic Act
International Agencies
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
World Health Organization
European Medicines Evaluation Agency (EMEA)
European Department for the Quality of Medicines
European Union Drug Regulatory Authority Network (Eudranet)
Leading Industry Organizations
Pharmaceutical Research and Manufacturers Association
Drug Information Association
Biotechnology Industry Organization
International Federation of Pharmaceutical Manufacturers Associations
European Federation of Pharmaceutical Industries and Associations (EFPIA)
Japan Pharmaceutical Manufacturers Association (JPMA)
Canada′s Research-Based Pharmaceutical Companies (formerly PMAC)
The Association of the British Pharmaceutical Industry (ABPI)
American Pharmacists Association (APhA) (the largest professional association of pharmacists in the U.S.)
Academic and Other Independent Research Centers for Pharmaceutical Policy
Center for Medicines Research International (U.K.)
Tufts University Center for the Study of Drug Development
Georgetown University Center for Drug Development Science
National Drug Regulatory Agencies Outside of the U.S.
Scientific Institute of Public Health - Louis Pasteur (IPH), Belgium
Health Canada, Canada
Danish Medicines Agency, Denmark
Agence Francaise de Securite Sanitaire des Produits de Sante, France
National Agency for Medicines, Finland
Federal Institute for Drugs and Medical Devices (BfArM), Germany
National Drug Organisation (EOF), Greece
Irish Medicines Board, Ireland
Istituto Superiore di Sanita (ISS), Italy
Pharmaceutical Food and Safety Bureau (PFSB), Japan
National Institute for Public Health and the Environment (RIVM), The Netherlands
Norwegian Medicines Agency, Norway
Infarmed, Portugal
Spanish Medicines Agency, Spain
Medical Products Agency (MPA), Sweden
Medicines and Healthcare Products Regulatory Agency (MHRA), UK (formerly the British Medicines Control Agency)