Medicines Agency

from Wikipedia, the free encyclopedia

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

Center for Drug Evaluation and Research of the US-FDA in Silver Spring (USA)
European Medicines Agency building in Amsterdam since 2019
  • 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.
  • 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
ArgentinaArgentina Argentina Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) National Administration of Drugs, Foods and Medical Devices
AustraliaAustralia Australia Therapeutic Goods Administration (TGA) -
Australian Pesticides and Veterinary Medicines Authority (APVMA) -
BelgiumBelgium 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)
BrazilBrazil Brazil Agência Nacional de Vigilância Sanitária (ANVISA) Brazilian Health Regulatory Agency
BulgariaBulgaria Bulgaria Изпълнителна агенция по лекарствата Bulgarian Drug Agency
Българска Агенция по Безопасност на Храните, Ветеринарномедицински продукти Bulgarian Food Safety Agency, Veterinary medicinal products
China People's RepublicPeople's Republic of China People's Republic of China 国家 药品 监督 管理局 ( Chinese ) National Medical Products Administration (NMPA)
GermanyGermany 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
DenmarkDenmark Denmark Lægemiddelstyrelsen Danish Medicines Agency
EstoniaEstonia Estonia Ravimiamet State Agency of Medicines
FinlandFinland Finland Lääkealan turvallisuus- ja kehittämiskeskus Finnish Medicines Agency (fimea)
FranceFrance 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
GreeceGreece Greece Εθνικός Οργανισμός Φαρμάκων (ΕΟΦ) National Organization for Medicines
IndiaIndia India Central Drugs Standard Control Organization (CDSCO) -
IndonesiaIndonesia Indonesia Badan Pengawas Obat dan Makanan ( Badan POM ) National Agency of Drug and Food Control (NA-DFC)
IranIran Iran Iran's Food and Drug Administration (IFDA)
IrelandIreland Ireland To tÚdarás Rialála Táirgá Sláinte Health Products Regulatory Authority (HPRA)
Roinn Talmaíochta, Bia agus Mara Department of Agriculture, Food and the Marine
IcelandIceland Iceland Lyfjastof now Icelandic Medicines Agency (IMA)
IsraelIsrael Israel Ministry of Health - Pharmaceutical Division
ItalyItaly 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
JapanJapan 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)
CanadaCanada Canada Health Canada (HC) / Santé Canada (SC) -
CroatiaCroatia 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
LatviaLatvia Latvia Zāļu valsts aģentūra (ZVA) State Agency of Medicines of Latvia
Pārtikas un veterinārais dienests (PVD) Food and Veterinary Service
LiechtensteinLiechtenstein Liechtenstein Office for Health / Department of Medicines Office of Health / Dpt. of Pharmaceuticals
LithuaniaLithuania 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
LuxembourgLuxembourg Luxembourg Ministère de la Santé / Direction de la Santé Ministry of Health
MalaysiaMalaysia Malaysia National Pharmaceutical Regulatory Agency (NPRA)
MaltaMalta Malta Malta Medicines Authority (MMA)
Veterinary Regulation Directorate
MexicoMexico Mexico Comisión Federal para la Protección contra Riesgos Sanitarios (Cofepris) Federal Commission for the Protection against Sanitary Risk
New ZealandNew Zealand New Zealand New Zealand Medicines and Medical Devices Safety Authority ( Medsafe ) -
NetherlandsNetherlands Netherlands College ter Beoordeling van Geneesmiddelen (CBG) Medicines Evaluation Board (MEB)
NorwayNorway Norway Statens legemiddelverk Norwegian Medicines Agency (NOMA)
AustriaAustria 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
PolandPoland Poland Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
PortugalPortugal 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
RomaniaRomania 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
RussiaRussia Russia Федеральная служба по надзору в сфере здравоохранения (Росздравнадзор) Federal Service for Surveillance in Healthcare (Roszdravnadzor)
Saudi ArabiaSaudi Arabia Saudi Arabia الهيئة العامة للغذاء والدواء Saudi Food and Drug Authority (SFDA)
SwedenSweden Sweden Läkemedelsverket Medical Products Agency
SwitzerlandSwitzerland Switzerland Swissmedic -
SingaporeSingapore Singapore Health Sciences Authority (HSA)
Penguasa Sains Kesihatan ( Malaysian )
卫生 科学 局 ( Chinese )
SlovakiaSlovakia 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
SloveniaSlovenia Slovenia Javna Agencija Republike Slovenije za zdravila in medicinske pripomočke (JAZMP) Agency for Medicinal Products and Medical Devices of the Republic of Slovenia
SpainSpain Spain Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) Spanish Agency of Medicines and Medical Devices
South AfricaSouth Africa South Africa South African Health Products Regulatory Authority (SAHPRA) -
Korea SouthSouth Korea South Korea Ministry of Food and Drug Safety (MFDS)
ThailandThailand Thailand Food and Drug Administration (Thai FDA)
Czech RepublicCzech Republic 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
TurkeyTurkey Turkey Türkiye İlaç ve Tıbbi Cihaz Kurumu (TİTCK) Turkish Medicines and Medical Devices Agency (TMMDA)
UkraineUkraine Ukraine Державна служба України з лікарських засобів та контролю за наркотиками State Service of Ukraine on Medicines and Drugs Control (SMDC)
HungaryHungary 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 KingdomUnited Kingdom United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) -
Veterinary Medicines Directorate (VMD) -
United StatesUnited States United States US Food and Drug Administration (FDA) -
Cyprus RepublicRepublic of Cyprus Cyprus Υπουργείο Υγείας, Φαρμακευτικές Υπηρεσίες Ministry of Health, Pharmaceutical Services

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