Medicines Agency
A drug agency is a government institution. Their task is the sovereign application and implementation of pharmaceutical law to protect public health .
Drug authorities are responsible in particular for drug approval , for monitoring drug production in terms of GMP , for approving and monitoring clinical studies in terms of GCP , for drug safety , and sometimes even for batch release of individual drugs such as vaccines .
In recent years, drug authorities have been transformed into agencies in many countries.
Selected examples
- USA: One of the best-known and oldest drug agencies is the Food and Drug Administration (FDA). She is not only responsible for chemical and biological drugs and medical devices , but also for food monitoring. The FDA has set international standards in many areas of drug approval and monitoring.
- European Union: The drug authority in the EU is the European Commission . This grants the drug approval in a centralized procedure . Many other tasks lie exclusively with the member states. From a technical point of view, the Pharmaceuticals division is part of the European Commission's Directorate-General for Health and Consumers. The European Medicines Agency is often seen as a medicines authority, but strictly speaking it is a coordinating agency. The committees of the European Medicines Agency, made up of employees from national authorities, draw up reports that the EU Commission uses in its decision. The European Medicines Agency also provides various central services such as the EudraVigilance database. At the European level, the national drug authorities of the EU member states work together as " Heads of Medicines Agencies ".
- Council of Europe: The European Directorate for the Quality of Medicines (EDQM) operates on a completely different level . It publishes the European Pharmacopoeia and plays an important role in manufacturing surveillance. Among other things, the EDQM issues certificates of conformity (CEPs) for the production of medicinal substances and pharmaceutical excipients in accordance with the European Pharmacopoeia.
- Germany: Due to the federal structure, a number of authorities in Germany are responsible for drug monitoring. Originally, only federal state authorities were responsible for registering and monitoring medicinal products. These authorities, which work together in the ZLG , are now monitoring the production of drugs on site as well as ongoing clinical studies. According to the German Medicines Act, central tasks are taken over by various higher federal authorities : For example, the Federal Institute for Drugs and Medical Devices (BfArM) in Bonn is responsible for the approval and monitoring of low molecular weight and biotechnologically manufactured drugs and medical devices; the Paul Ehrlich Institute (PEI) in Langen is responsible for biological drugs such as vaccines , drugs for novel therapies (gene therapies, cell therapies) and blood and tissue preparations; the Federal Office for Consumer Protection and Food Safety (BVL) in Berlin is responsible for the approval and monitoring of veterinary drugs.
- Austria: In Austria, the medical market supervision , a division of the Austrian Agency for Health and Food Safety (AGES), is responsible for various tasks such as approval and production monitoring. Legally, the division founded in 2006 under the name AGES-PharmMed is a company on behalf of the Republic of Austria. Some sovereign tasks are carried out by the likewise newly formed Federal Office for Safety in Health Care (BASG). The medical market supervision and the Federal Office have taken over their tasks from the Federal Ministry for Health, Family and Youth .
- Switzerland: In Switzerland, since 2002, Swissmedic , a federal institution under public law with its headquarters in Bern, has been the supervisory authority for drugs, medical devices and veterinary drugs. Swissmedic is affiliated with the Federal Department of Home Affairs .
Tabular list of drug authorities
country | authority | Authority name in English |
---|---|---|
Argentina | Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) | National Administration of Drugs, Foods and Medical Devices |
Australia | Therapeutic Goods Administration (TGA) | - |
Australian Pesticides and Veterinary Medicines Authority (APVMA) | - | |
Belgium | Agence Fédérale des Médicaments et des Produits de Santé (AFMPS) / Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (FAGG) | Federal Agency for Medicines and Health Products (FAMHP) |
Brazil | Agência Nacional de Vigilância Sanitária (ANVISA) | Brazilian Health Regulatory Agency |
Bulgaria | Изпълнителна агенция по лекарствата | Bulgarian Drug Agency |
Българска Агенция по Безопасност на Храните, Ветеринарномедицински продукти | Bulgarian Food Safety Agency, Veterinary medicinal products | |
People's Republic of China | 国家 药品 监督 管理局 ( Chinese ) | National Medical Products Administration (NMPA) |
Germany | Federal Institute for Drugs and Medical Devices (BfArM) | Federal Institute for Drugs and Medical Devices |
Paul Ehrlich Institute (PEI) | Paul Ehrlich Institute | |
Federal Office for Consumer Protection and Food Safety (BVL) | Federal Office of Consumer Protection and Food Safety | |
Denmark | Lægemiddelstyrelsen | Danish Medicines Agency |
Estonia | Ravimiamet | State Agency of Medicines |
Finland | Lääkealan turvallisuus- ja kehittämiskeskus | Finnish Medicines Agency (fimea) |
France | Agence nationale de sécurité du médicament et des produits de santé (ANSM) | The French National Agency for Medicines and Health Products Safety |
Agence Nationale du Médicament Vétérinaire (ANMV) / Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (Anses) | The French Agency for Veterinary Medicinal Products / French Agency for Food, Environmental and Occupational Health & Safety | |
Greece | Εθνικός Οργανισμός Φαρμάκων (ΕΟΦ) | National Organization for Medicines |
India | Central Drugs Standard Control Organization (CDSCO) | - |
Indonesia | Badan Pengawas Obat dan Makanan ( Badan POM ) | National Agency of Drug and Food Control (NA-DFC) |
Iran | Iran's Food and Drug Administration (IFDA) | |
Ireland | To tÚdarás Rialála Táirgá Sláinte | Health Products Regulatory Authority (HPRA) |
Roinn Talmaíochta, Bia agus Mara | Department of Agriculture, Food and the Marine | |
Iceland | Lyfjastof now | Icelandic Medicines Agency (IMA) |
Israel | Ministry of Health - Pharmaceutical Division | |
Italy | Agenzia Italiana del Farmaco (AIFA) | Italian Medicines Agency |
Istituto Superiore di Sanità (ISS) | National Institute of Health | |
Ministero della Salute, Direzione Generale della Sanità Animale e dei Farmaci Veterinari (DGSAF) | Ministry of Health, Directorate-General for animal health and veterinary medicinal products | |
Japan | (独立 行政 法人) 医 薬 品 医療 機器 総 合 機構, (dokuritsu gyōsei hōjin) iyakuhin iryōkiki sōgō kikō | Pharmaceuticals and Medical Devices Agency (PMDA) |
Canada | Health Canada (HC) / Santé Canada (SC) | - |
Croatia | Agencija za lijekove i medicinske proizvode (HALMED) | Croatian Agency for Medicinal Products and Medical Devices |
Ministarstvo poljoprivrede, Uprava za Veterinarstvo i sigurnost hrane | Ministry of Agriculture, Veterinary and Food Safety Directorate | |
Latvia | Zāļu valsts aģentūra (ZVA) | State Agency of Medicines of Latvia |
Pārtikas un veterinārais dienests (PVD) | Food and Veterinary Service | |
Liechtenstein | Office for Health / Department of Medicines | Office of Health / Dpt. of Pharmaceuticals |
Lithuania | Valstybinė vaistų kontrolės tarnyba | State Medicines Control Agency |
Valstybinė maisto ir veterinaijos tarnyba; Nacionalinis maisto ir veterinarijos rizikos vertinimo institutas |
State Food and Veterinary Service; National Food and Veterinary Risk Assessment Institute |
|
Luxembourg | Ministère de la Santé / Direction de la Santé | Ministry of Health |
Malaysia | National Pharmaceutical Regulatory Agency (NPRA) | |
Malta | Malta Medicines Authority (MMA) | |
Veterinary Regulation Directorate | ||
Mexico | Comisión Federal para la Protección contra Riesgos Sanitarios (Cofepris) | Federal Commission for the Protection against Sanitary Risk |
New Zealand | New Zealand Medicines and Medical Devices Safety Authority ( Medsafe ) | - |
Netherlands | College ter Beoordeling van Geneesmiddelen (CBG) | Medicines Evaluation Board (MEB) |
Norway | Statens legemiddelverk | Norwegian Medicines Agency (NOMA) |
Austria | Agency for Health and Food Safety (AGES) | Austrian Agency for Health and Food Safety |
Federal Office for Safety in Health Care (BASG) | Austrian Federal Office for Safety in Health Care | |
Poland | Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych | Office for Registration of Medicinal Products, Medical Devices and Biocidal Products |
Portugal | INFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde, IP | INFARMED - National Authority of Medicines and Health Products, IP |
Direcção-Geral de Alimentação e Veterinária (DGAV) | Food and Veterinary Directorate General | |
Romania | Agenția Națională a Medicamentului și a Dispozitivelor Medicale (ANMDM) | National Agency of Medicines and Medical Devices |
Institutul pentru Controlul Produselor Biologice si Medicamentelor de Uz Veterinar (ICBMV) | Institute for Control of biological products and veterinary medicines | |
Russia | Федеральная служба по надзору в сфере здравоохранения (Росздравнадзор) | Federal Service for Surveillance in Healthcare (Roszdravnadzor) |
Saudi Arabia | الهيئة العامة للغذاء والدواء | Saudi Food and Drug Authority (SFDA) |
Sweden | Läkemedelsverket | Medical Products Agency |
Switzerland | Swissmedic | - |
Singapore |
Health Sciences Authority (HSA) Penguasa Sains Kesihatan ( Malaysian ) 卫生 科学 局 ( Chinese ) |
|
Slovakia | Štátny ústav pre kontrolu liečiv (ŠÚKL) | State Institute for Drug Control |
Ústav štátnej kontroly veterinárnych biopreparátov a liečiv (ÚŠKVBL) | Institute for State Control of Veterinary Biologicals and Medicaments | |
Slovenia | Javna Agencija Republike Slovenije za zdravila in medicinske pripomočke (JAZMP) | Agency for Medicinal Products and Medical Devices of the Republic of Slovenia |
Spain | Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) | Spanish Agency of Medicines and Medical Devices |
South Africa | South African Health Products Regulatory Authority (SAHPRA) | - |
South Korea | Ministry of Food and Drug Safety (MFDS) | |
Thailand | Food and Drug Administration (Thai FDA) | |
Czech Republic | Státní ústav pro kontrolu léčiv (SÚKL) | State Institute for Drug Control |
Ústavu pro státní kontrolu veterinárních biopreparátů a léčiv (ÚSKVBL) | Institute for State Control of Veterinary Biologicals and Medicaments | |
Turkey | Türkiye İlaç ve Tıbbi Cihaz Kurumu (TİTCK) | Turkish Medicines and Medical Devices Agency (TMMDA) |
Ukraine | Державна служба України з лікарських засобів та контролю за наркотиками | State Service of Ukraine on Medicines and Drugs Control (SMDC) |
Hungary | Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet (OGYÉI) | National Institute of Pharmacy and Nutrition |
Nemzeti Élelmiszerlánc-biztonsági Hivatal (NÉBIH) | National Food Chain Safety Office, Directorate of Veterinary Medicinal Products | |
United Kingdom | Medicines and Healthcare products Regulatory Agency (MHRA) | - |
Veterinary Medicines Directorate (VMD) | - | |
United States | US Food and Drug Administration (FDA) | - |
Cyprus | Υπουργείο Υγείας, Φαρμακευτικές Υπηρεσίες | Ministry of Health, Pharmaceutical Services |