European Union (EU) Mutual Recognition Agreement
The U.S.-EU Mutual Recognition Agreement (MRA) Sectoral Annex for Pharmaceutical Good Manufacturing Practices (GMP) MRA entered into force on November 1, 2017. Initially the agreement included only pharmaceuticals intended for human use. On May 31, 2023 the U.S. Food and Drug Administration (FDA) and the European Union (EU) announced their decision to expand the scope of the MRA to include inspections of veterinary pharmaceuticals. To date, the FDA has completed capability for all 27 of the EU countries' human drug regulatory authorities, and 18 of the EU countries’ veterinary drug regulatory authorities.
FDA also has MRAs in force with Switzerland and the United Kingdom.
Country | Regulatory authority for medicinal products for human and/or veterinary use* | Type | Date Recognized |
---|---|---|---|
Austria | Austrian Agency for Health and Food Safety / Österreichische Agentur für Gesundheit und Ernährungssicherheit (GmbH) |
Human Drugs Animal Drugs |
November 1, 2017 May 30, 2023 |
Belgium | Federal agency for medical and health products / Fedraal Agentschap voor geneesmiddelen en gezondheidsproducten/ Agence fédérale des médicaments et produits de santé |
Human Drugs Animal Drugs |
November 16, 2018 May 30, 2023 |
Bulgaria | Bulgarian Drug Agency ИЗПЪЛНИТЕЛНА АГЕНЦИЯ ПО ЛЕКАРСТВАТА |
Human Drugs | April 29, 2019 |
Bulgaria | Bulgarian Food Safety Agency / Българска агенция по безопасност на храните**** | Animal Drugs | May 30, 2023 |
Croatia | Agency for Medicinal Products and Medical Devices / Agencija za lijekove i medicinske proizvode (HALMED) |
Human Drugs |
November 1, 2017 |
Cyprus |
The Cyprus Council of Veterinary Medicinal Products (CyCVMPs) – The Veterinary Services***** |
Animal Drugs | October 8.2024 |
Cyprus | Ministry of Health – Pharmaceutical Services Φαρμακευτικές Υπηρεσίες, Υπουργείο Υγείας |
Human Drugs | April 29, 2019 |
Czech Republic | Institute for State Control of Veterinary Biologicals and Medicines / Ústav pro státní kontrolu veterinárních biopreparátů a léčiv (USKVBL) | Animal Drugs | October 18, 2024 |
Czech Republic | State Institute for Drug Control | Human Drugs | March 1, 2018 |
Denmark | Danish Medicines Agency / Laegemiddelstyrelsen |
Human Drugs Animal Drugs |
November 16, 2018 May 30, 2023 |
Estonia | State Agency of Medicines / Ravimiamet |
Human Drugs Animal Drugs |
November 28, 2019 May 30, 2023 |
Finland | Finnish Medicines Agency / Lääkealan turvallisuus- ja kehittämiskeskus (FIMEA) |
Human Drugs Animal Drugs |
November 16, 2018 May 30, 2023 |
France | French National Agency for Medicines and Health Products Safety / Agence nationale de sécurité du medicament et des produits de santé | Human Drugs | November 1, 2017 |
France | French Agency for Food, Environmental and Occupational Health & Safety – French Agency for Veterinary Medicinal Products / Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail – Agence nationale du médicament vétérinaire (Anses-ANMV) | Animal Drugs | May 30, 2023 |
Germany | Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (ZLG) |
Human Drugs Animal Drugs |
June 26, 2019 August 7, 2024 |
Greece | National Organisation for Medicines |
Human Drugs Animal Drugs |
March 1, 2018 May 30, 2023 |
Hungary |
National Institute of Pharmacy and Nutrition | Human Drugs | March 1, 2018 |
Hungary | National Food Chain Safety Office, Directorate of Veterinary Medicinal Products / Nemzeti Élelmiszerlánc-biztonsági Hivatal, Állatgyógyászati Termékek Igazgatósága (ÁTI) | Animal Drugs | May 30, 2023 |
Ireland |
Health Products Regulatory Authority (HPRA) |
Human Drugs Animal Drugs |
June 1, 2018 May 30, 2023 |
Italy | Italian Medicines Agency / Agenzia Italiana del Farmaco | Human Drugs | November 1, 2017 |
Latvia |
State Agency of Medicines / Zāļu valsts aģentūra | Human Drugs | November 16, 2018 |
Latvia | Food and Veterinary Service | Animal Drugs | November 28,2023 |
Lithuania |
State Medicines Control Agency / Valstybinė vaistų kontrolės tarnyba |
Human Drugs |
June 1, 2018 |
Lithuania | State Food and Veterinary Service / Valstybine maisto ir veterinarijos tarnyba | Animal Drugs | July 18, 2024 |
Luxembourg | Minìstere de la Santé, Division de la Pharmacie et des Médicaments |
Human Drugs Animal Drugs |
June 10, 2019 May 30, 2023 |
Malta | Medicines Regulatory Authority*** | Human Drugs | November 1, 2017 |
Netherlands | Healthcare Inspectorate / Inspectie voor de Gezondheidszorg (IGZ) | Human Drugs | June 10, 2019 |
Netherlands | Medicines Evaluation Board (MEB) / College ter Beoordeling van Geneesmiddelen (CBG) Veterinary Medicinal Products Unit / Bureau Diergeneesmiddelen | Animal Drugs | May 30, 2023 |
Poland | The Main Pharmaceutical Inspectorate/ Główny Inspektorat Farmaceutyczny (GIF) |
Human Drugs Animal Drugs |
February 7, 2019 May 30, 2023 |
Portugal |
National Authority of Medicines and Health Products / INFARMED, I.P / Autoridade Nacional do Medicamento e Produtos de Saúde, I.P |
Human Drugs |
September 14, 2018 |
Portugal | General Directorate of Food and Veterinary / Direção-Geral de Alimentação e Veterinária (DGAV) | Animal Drugs | May 30, 2023 |
Romania | National Agency for Medicines and Medical Devices | Human Drugs | March 1, 2018 |
Slovakia | State Institute for Drug Control / Štátny ústav pre kontrolu liečiv (ŠÚKL)** | Human Drugs | July 11, 2019 |
Slovenia | Agency for Medicinal Products and Medical Devices of the Republic of Slovenia Javna agencija Republike Slovenije za zdravila in medicinske pripomočke (JAZMP) |
Human Drugs Animal Drugs |
February 7, 2019 May 30, 2023 |
Spain | Spanish Agency of Medicines and Medical Devices/ Agencia Española de Medicamentos y Productos Sanitarios |
Human Drugs Animal Drugs |
November 1, 2017 May 30, 2023 |
Sweden | Medical Products Agency / Läkemedelsverket |
Human Drugs Animal Drugs |
November 1, 2017 September 26, 2023 |
United States | Food and Drug Administration |
Human Drugs Animal Drugs |
November 1, 2017 May 30, 2023 |
*Limitations: The capability determinations apply to routine surveillance inspections. In the future the following product and inspection types may be included in the coverage of the agreement, pending further consideration:
- Vaccines for human use
- Plasma derived pharmaceuticals
- Investigational products (clinical trial material), specific to each agreement
The FDA and the EU have considered the issue of expanding the scope of the MRA to include vaccines and plasma-derived pharmaceuticals for human use. FDA has decided to consider the issue again in July 2025 based on further assessment.
Excluded from the MRA scope are: Advanced Therapy Medicinal Products (ATMPs), human blood, human plasma, human tissues and organs, and veterinary immunologicals.
** Malta – capability for human medicines excludes sterile or aseptically processed drugs and biological products; and nonsterile, highly potent drug products.
*** Slovakia – for human medicines only for inspections of chemically synthesized active pharmaceutical ingredients intended for use in drug products for human oral administration and manufactured in a dedicated, single product facility.
**** Bulgaria – capability for veterinary products excludes sterile veterinary drug products.
***** Cyprus – capability for veterinary products excludes sterile or aseptically processed drugs and biological products; and nonsterile, highly potent drug products.
Resources
- Frequently Asked Questions - Mutual Recognition Agreement
- FDA Expands Mutual Recognition Agreement with European Union, OGPS Statement, May 31, 2023
- Ensuring Patient Safety and Drug Manufacturing Quality Through Partnership with European Union Regulators
- U.S.-EU Mutual Recognition Agreement Sectoral Annex for GMPs
- Press Release - FDA takes unprecedented step toward more efficient global pharmaceutical manufacturing inspections
- Press Release- Mutual Recognition promises new framework for pharmaceutical inspections for United States and European Union
- Four more EU Member States benefit from EU-US mutual recognition agreement for inspections