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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 place with the EU and the United Kingdom, respectively. FDA and the EU have collaborated since May 2014 to evaluate the ways in which each regulator inspects drug manufacturers and assesses the risk and benefits of mutual recognition of drug inspections. FDA is continuing its collaboration with the United Kingdom since it exited the EU as of January 1, 2021. 

FDA will continue to perform some inspections in foreign countries with capable inspectorates, such as product manufacturing assessment inspections to support marketing approval decisions. However, FDA expects to perform fewer routine surveillance inspections in foreign countries with a capable inspectorate.

Under the MRAs in place, FDA collaborates with inspectorates in the EU and the United Kingdom and is reviewing their recent inspection reports and related information to determine a manufacturer’s suitability for the U.S. market in lieu of an FDA site inspection.

Authority Recognized July 11, 2019

Country Regulatory authority for medicinal products for human use*
Slovakia State Institute for Drug Control / Štátny ústav pre kontrolu liečiv (ŠÚKL)**

Authority Recognized June 26, 2019

Country Regulatory authority for medicinal products for human use*
Germany Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (ZLG)

Authorities Recognized June 10, 2019

Country Regulatory authority for medicinal products for human use*
Luxembourg Minìstere de la Santé, Division de la Pharmacie et des Médicaments
Netherlands Healthcare Inspectorate / Inspectie voor de Gezondheidszorg (IGZ)

Authorities Recognized April 29, 2019

Country Regulatory authority for medicinal products for human use*
Bulgaria Bulgarian Drug Agency
ИЗПЪЛНИТЕЛНА АГЕНЦИЯ ПО ЛЕКАРСТВАТА
Cyprus Minnistry of Health – Pharmaceutical Services
Φαρμακευτικές Υπηρεσίες, Υπουργείο Υγείας

Authorities Recognized February 7, 2019

Country Regulatory authority for medicinal products for human use*
Poland The Main Pharmaceutical Inspectorate/
Główny Inspektorat Farmaceutyczny (GIF)
Slovenia Agency for Medicinal Products and Medical Devices of the Republic of Slovenia
Javna agencija Republike Slovenije za zdravila in medicinske pripomočke (JAZMP)

Authority Recognized November 28, 2018

Country Regulatory authority for medicinal products for human use*
Estonia State Agency of Medicines / Ravimiamet

Authorities Recognized November 16, 2018

Country Regulatory authority for medicinal products for human use*
Belgium Federal agency for medical and health products / Fedraal Agentschap voor geneesmiddelen en gezondheidsproducten/ Agence fédérale des médicaments et produits de santé
Denmark Danish Medicines Agency / Laegemiddelstyrelsen
Finland Finnish Medicines Agency / Lääkealan turvallisuus- ja kehittämiskeskus (FIMEA)
Latvia State Agency of Medicines / Zāļu valsts aģentūra

Authority Recognized September 14, 2018

Country Regulatory authority for medicinal products for human use*
Portugal National Authority of Medicines and Health Products / INFARMED, I.P / Autoridade Nacional do Medicamento e Produtos de Saúde, I.P

Authorities Recognized June 1, 2018

Country Regulatory authority for medicinal products for human use*
Ireland Health Products Regulatory Authority (HPRA)
Lithuania State Medicines Control Agency / Valstybinė vaistų kontrolės tarnyba

Authorities Recognized March 1, 2018

Country Regulatory authority for medicinal products for human use*
Greece National Organisation for Medicines
Hungary National Institute of Pharmacy and Nutrition
Czech Republic State Institute for Drug Control
Romania National Agency for Medicines and Medical Devices

Authorities Recognized November 1, 2017

Country Regulatory authority for medicinal products for human use*
United States Food and Drug Administration
Austria Austrian Agency for Health and Food Safety / Österreichische Agentur für Gesundheit und Ernährungssicherheit (GmbH)
Croatia Agency for Medicinal Products and Medical Devices / Agencija za lijekove i medicinske proizvode (HALMED)
France French National Agency for Medicines and Health Products Safety / Agence nationale de sécurité du medicament et des produits de santé
Italy Italian Medicines Agency / Agenzia Italiana del Farmaco
Malta Medicines Regulatory Authority***
Spain Spanish Agency of Medicines and Medical Devices/ Agencia Española de Medicamentos y Productos Sanitarios
Sweden Medical Products Agency / Läkemedelsverket
United Kingdom Medicines and Healthcare products Regulatory Agency

Resources

*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)
  • Veterinary products

Excluded from the MRA scope are: Advanced Therapy Medicinal Products (ATMPs), human blood, human plasma, human tissues and organs 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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