International Programs

Mutual Recognition Agreement (MRA)

A New World for Pharmaceutical Inspections- The Mutual Recognition Agreement

The Mutual Recognition Agreement (MRA) between FDA and European Union allows 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 the FDA determined those authorities are capable of conducting inspections that met U.S. requirements.  FDA and the EU have collaborated since May 2014 to evaluate the way they each inspect drug manufacturers and assess the risk and benefits of mutual recognition of drug inspections.

MRA:

  • Yields greater efficiencies for U.S. and E.U. regulatory systems by avoiding duplication of inspections
  • Enables reallocation of resources towards inspection of drug manufacturing facilities with potentially higher public health risks across the globe

FDA will continue to perform some inspections in EU 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 EU countries with a capable inspectorate.

FDA is collaborating with the following inspectorates it has assessed as capable and is reviewing their recent inspection reports and related information in determining each manufacturer’s suitability for the U.S. market in lieu of an FDA site inspection. FDA expects to complete its capability assessment of all EU inspectorates by July 2019. 

Country Recognized November 28, 2018

CountryRegulatory authority for medicinal products for human use*
EstoniaState Agency of Medicines / Ravimiamet

Countries Recognized November 16, 2018

CountryRegulatory authority for medicinal products for human use*
BelgiumFederal 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)

LatviaState Agency of Medicines / Zāļu valsts aģentūra

Country Recognized September 14, 2018

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

Countries Recognized June 1, 2018

CountryRegulatory authority for medicinal products for human use*
IrelandHealth Products Regulatory Authority (HPRA)
LithuaniaState Medicines Control Agency / Valstybinė vaistų kontrolės tarnyba

Countries Recognized March 1, 2018

CountryRegulatory authority for medicinal products for human use*
GreeceNational Organisation for Medicines
HungaryNational Institute of Pharmacy and Nutrition
Czech RepublicState Institute for Drug Control
RomaniaNational Agency for Medicines and Medical Devices

Countries Recognized November 1, 2017

CountryRegulatory authority for medicinal products for human use*
United StatesFood and Drug Administration
AustriaAustrian Agency for Health and Food Safety / Österreichische Agentur für Gesundheit und Ernährungssicherheit (GmbH)
CroatiaAgency for Medicinal Products and Medical Devices / Agencija za lijekove i medicinske proizvode (HALMED)
FranceFrench National Agency for Medicines and Health Products Safety / Agence nationale de sécurité du medicament et des produits de santé
ItalyItalian Medicines Agency / Agenzia Italiana del Farmaco
MaltaMedicines Regulatory Authority
SpainSpanish Agency of Medicines and Medical Devices/ Agencia Española de Medicamentos y Productos Sanitarios
SwedenMedical Products Agency / Läkemedelsverket
United KingdomMedicines 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 human blood, human plasma, human tissues and organs and veterinary immunologicals.

 

 

 

Page Last Updated: 11/29/2018
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