| European Union |
EMA, European Medicines Agency
European Commission - Enterprise and Industry, Pharmaceuticals
European Heads of Medicines Agencies
EUR-Lex Access to European Union Law
European Commission (EC) Legislation: EUDRALex
European Directorate for the Quality of Medicines (EDQM) & Healthcare |
| National Competent Authorities in Europe |
Austria - Bundesamt für Sicherheit im Gesundheitswesen
Belgium - Federal Agency for Medicines and Health Products
Bulgaria - The Bulgarian Drug Agency
Cyprus - Ministry of Health of the Republic of Cyprus
Czech Republic - State Institute for Drug Control
Denmark - Danish Medicines Agency
Estonia - Ravimiamet State Agency of Medicines
Finland - National Agency for Medicines
France: Agence nationale de sécurité du médicament et des produits de santé (ansm)
Germany - Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
Germany - Paul-Ehrlich-Institut (PEI)
Greece - National Organisation for Medicines
Hungary - National Institute of Pharmacy
Iceland - Icelandic Medicines Control Agency
Ireland - Irish Medicines Board
Italy - Agenzia Italiana del Farmaco (AIFA)
Latvia - Valsts Zalu Agentura
Liechtenstein - Amt für Lebensmittelkontrolle und Veterinärwesen
Lithuania - State Medicines Control Agency of Lithuania
Luxembourg - Ministère de la Santé
Malta - Medicines Regulatory Unit Health Division
Norway - Medicines Agency
Poland - Urzad Rejestracji Produków Leczniczych, Wyrobów Medycznych i Produktów Biobójczych
Portugal - Instituto Nacional de Farmácia e do Medicamento (Infarmed)
Romania - Agentia Nationala a Medicamentului
Slovakia - Státny Ústav Pre Kontrolu Lieciv
Slovenia - Javna agencija Republike Slovenije za zdravila in medicinske pripomocke
Spain - Agencia Española del Medicamentos
Sweden - Medical Products Agency
Switzerland - Swissmedic
The Netherlands - College ter Beoordeling van Geneesmiddelen
United Kingdom - Medicines and Healthcare products Regulatory Agency (MHRA) |
| United States |
| US Food and Drug Administration (FDA)
National Institutes of Health, NIH
Code of Federal Regulations, CFR (US National Archives and Records Administration)
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| International Organizations |
ICH, International Conference on Harmonisation (of Technical Requirements for Registration of Pharmaceuticals for Human Use)
World Health Organization, WHO |
| Australia |
| Therapeutic Goods Administration, TGA |
| Canada |
| Health Products and Food Branch, Health Canada |
| Japan |
| Ministry of Health, Labour and Welfare |
| Organisations |
AusBiotech - Australia's Biotechnology Organisation
BayBio - Northern California's Life Science Association
London Bioscience Innovation Centre (LBIC)
London Biotechnology Network
Queensland Clinical Trial Network(QCTN) |
