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Mutual Recognition Agreement (MRA)

 

GO Image- A New World for Pharmaceutical Inspections- The Mutual Recognition Agreement

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. Before this MRA enters into force, the FDA must determine whether Switzerland is capable of conducting inspections that meet U.S. requirements, and the Swiss Agency for Therapeutic Products (Swissmedic), must make a similar determination with respect to the FDA meeting Swiss requirements. 

Country Regulatory authority for medicinal products for human and/or veterinary use* Date Recognized
United Kingdom Veterinary Medicines Directorate September 24, 2021
Slovakia State Institute for Drug Control / Štátny ústav pre kontrolu liečiv (ŠÚKL)** July 11, 2019
Germany Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (ZLG) June 26, 2019
Luxembourg Minìstere de la Santé, Division de la Pharmacie et des Médicaments June 10, 2019
Netherlands Healthcare Inspectorate / Inspectie voor de Gezondheidszorg (IGZ) June 10, 2019
Bulgaria Bulgarian Drug Agency
ИЗПЪЛНИТЕЛНА АГЕНЦИЯ ПО ЛЕКАРСТВАТА		 April 29, 2019
Cyprus Ministry of Health – Pharmaceutical Services
Φαρμακευτικές Υπηρεσίες, Υπουργείο Υγείας		 April 29, 2019
Poland The Main Pharmaceutical Inspectorate/
Główny Inspektorat Farmaceutyczny (GIF)		 February 7, 2019
Slovenia Agency for Medicinal Products and Medical Devices of the Republic of Slovenia
Javna agencija Republike Slovenije za zdravila in medicinske pripomočke (JAZMP)		 February 7, 2019
Estonia State Agency of Medicines / Ravimiamet November 28, 2019
Belgium Federal agency for medical and health products / Fedraal Agentschap voor geneesmiddelen en gezondheidsproducten/ Agence fédérale des médicaments et produits de santé November 16, 2018
Denmark Danish Medicines Agency / Laegemiddelstyrelsen November 16, 2018
Finland Finnish Medicines Agency / Lääkealan turvallisuus- ja kehittämiskeskus (FIMEA) November 16, 2018
Latvia State Agency of Medicines / Zāļu valsts aģentūra November 16, 2018
Portugal National Authority of Medicines and Health Products / INFARMED, I.P / Autoridade Nacional do Medicamento e Produtos de Saúde, I.P September 14, 2018
Ireland Health Products Regulatory Authority (HPRA) June 1, 2018
Lithuania State Medicines Control Agency / Valstybinė vaistų kontrolės tarnyba June 1, 2018
Greece National Organisation for Medicines March 1, 2018
Hungary National Institute of Pharmacy and Nutrition March 1, 2018
Czech Republic State Institute for Drug Control March 1, 2018
Romania National Agency for Medicines and Medical Devices March 1, 2018
United States Food and Drug Administration November 1, 2017
Austria Austrian Agency for Health and Food Safety / Österreichische Agentur für Gesundheit und Ernährungssicherheit (GmbH) November 1, 2017
Croatia Agency for Medicinal Products and Medical Devices / Agencija za lijekove i medicinske proizvode (HALMED) November 1, 2017
France French National Agency for Medicines and Health Products Safety / Agence nationale de sécurité du medicament et des produits de santé November 1, 2017
Italy Italian Medicines Agency / Agenzia Italiana del Farmaco November 1, 2017
Malta Medicines Regulatory Authority*** November 1, 2017
Spain Spanish Agency of Medicines and Medical Devices/ Agencia Española de Medicamentos y Productos Sanitarios November 1, 2017
Sweden Medical Products Agency / Läkemedelsverket November 1, 2017
United Kingdom Medicines and Healthcare products Regulatory Agency 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:

  • Vaccines for human use
  • Plasma derived pharmaceuticals
  • Investigational products (clinical trial material), specific to each agreement
  • Veterinary products (for European Union authorities

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 (Swiss MRA), and veterinary immunologicals.

** Slovakia – 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.

*** Malta - capability excludes sterile or aseptically processed drugs and biological products; and non-sterile, highly potent drug products.

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