Mutual Recognition Agreements (MRA)
Mutual Recognition Agreements (MRAs) between FDA and foreign regulatory authorities allow drug inspectors to rely upon information from drug inspections conducted within each other’s borders. Under the Food and Drug Administration Safety and Innovation Act, enacted in 2012, FDA has the authority to enter into agreements to recognize drug inspections conducted by foreign regulatory authorities if FDA determined those authorities are capable of conducting inspections that met U.S. requirements.
MRAs:
- Yield greater efficiencies for U.S. and foreign regulatory systems by avoiding duplication of inspections; and,
- Enable reallocation of resources towards inspection of drug manufacturing facilities with potentially higher public health risks across the globe.
FDA has MRAs in force with the EU and the United Kingdom, respectively. On January 12, 2023, the FDA signed an MRA with Switzerland. The MRA entered into force on July 27, 2023, after the FDA determined whether Switzerland is capable of conducting inspections that meet U.S. requirements, and the Swiss Agency for Therapeutic Products (Swissmedic), made a similar determination with respect to the FDA meeting Swiss requirements.
| Country | Regulatory authority for medicinal products for human and/or veterinary use* | Type | Date Recognized |
|---|---|---|---|
| Switzerland | Swissmedic - Swiss Agency for Therapeutic Products/Schweizerisches Heilmittelinstitute |
Human Drugs Animal Drugs |
July 26, 2023 |
| United Kingdom | Veterinary Medicines Directorate |
Animal Drugs |
September 24, 2021 |
| Slovakia | State Institute for Drug Control / Štátny ústav pre kontrolu liečiv (ŠÚKL)** |
Human Drugs |
July 11, 2019 |
| Germany | Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (ZLG) | Human Drugs | June 26, 2019 |
| Luxembourg | Minìstere de la Santé, Division de la Pharmacie et des Médicaments |
Human Drugs Animal Drugs |
June 10, 2019 May 30, 2023 |
| 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 |
| Bulgaria |
Bulgarian Drug Agency |
Human Drugs |
April 29, 2019 |
| Bulgaria | Bulgarian Food Safety Agency / Българска агенция по безопасност на храните**** | Animal Drugs | May 30, 2023 |
| Cyprus | Ministry of Health – Pharmaceutical Services Φαρμακευτικές Υπηρεσίες, Υπουργείο Υγείας |
Human Drugs | April 29, 2019 |
| Poland | The Main Pharmaceutical Inspectorate/ Główny Inspektorat Farmaceutyczny (GIF) |
Human Drugs Animal Drugs |
February 7, 2019 May 30, 2023 |
| 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 |
| Estonia | State Agency of Medicines / Ravimiamet |
Human Drugs Animal Drugs |
November 28, 2019 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 |
| Denmark | Danish Medicines Agency / Laegemiddelstyrelsen |
Human Drugs Animal Drugs |
November 16, 2018 May 30, 2023 |
| Finland | Finnish Medicines Agency / Lääkealan turvallisuus- ja kehittämiskeskus (FIMEA) |
Human Drugs Animal Drugs |
November 16, 2018 May 30, 2023 |
| Latvia | State Agency of Medicines / Zāļu valsts aģentūra | Human Drugs | November 16, 2018 |
| 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 |
| Ireland | Health Products Regulatory Authority (HPRA) |
Human Drugs Animal Drugs |
June 1, 2018 May 30, 2023 |
| Lithuania | State Medicines Control Agency / Valstybinė vaistų kontrolės tarnyba | Human Drugs | June 1, 2018 |
| 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 |
| Czech Republic | State Institute for Drug Control | Human Drugs | March 1, 2018 |
| Romania | National Agency for Medicines and Medical Devices | Human Drugs | March 1, 2018 |
| United States | Food and Drug Administration |
Human Drugs Animal Drugs |
November 1, 2017 May 30, 2023 |
| 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 |
| Croatia | Agency for Medicinal Products and Medical Devices / Agencija za lijekove i medicinske proizvode (HALMED) | Human Drugs | November 1, 2017 |
| 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 |
| Italy | Italian Medicines Agency / Agenzia Italiana del Farmaco | Human Drugs | November 1, 2017 |
| Malta | Medicines Regulatory Authority*** | Human Drugs | November 1, 2017 |
| 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 |
November 1, 2017 |
| United Kingdom | Medicines and Healthcare products Regulatory Agency | Human Drugs | November 1, 2017 |
*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:
For U.S.-EU MRA and U.S.-UK MRA:
- Vaccines for human use
- Plasma derived pharmaceuticals
- Investigational products (clinical trial material), specific to each agreement
For U.S.-Switzerland MRA:
- Vaccines for human use
The FDA and the UK have considered the issue of expanding the scope of the MRA to include vaccines and plasma-derived pharmaceuticals for human use, and decided to consider the issue again in July 2025 based on further assessment.
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, cells (Swissmedic MRA), and veterinary immunologicals.
** Malta – capability for human medicines excludes sterile or aseptically processed drugs and biological products; and non-sterile, 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.
Resources
- Frequently Asked Questions - Mutual Recognition Agreement
- FDA Mutual Recognition Agreement with Swissmedic Enters Into Force - OGPS Statement - (July 27 2023)
- FDA Expands Mutual Recognition Agreement with European Union, OGPS Statement, May 31, 2023
- Agreement on Mutual Recognition between the Swiss Confederation and the United States of America Relating to Pharmaceutical Good Manufacturing Practice, OGPS Statement, January 12, 2023
- FDA and United Kingdom Announce Mutual Recognition Agreement for Pharmaceutical Good Manufacturing Practice Inspections of Animal Drugs
- Ensuring Patient Safety and Drug Manufacturing Quality Through Partnership with European Union Regulators
- U.S.-UK Mutual Recognition Agreement
- 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