Mutual Recognition Agreement (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 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
- 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
- Frequently Asked Questions -Mutual Recognition Agreement
- 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
*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.