Mutual Recognition Agreement (MRA)
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 July 11, 2019
| Country | Regulatory authority for medicinal products for human use* |
|---|---|
| Slovakia | State Institute for Drug Control / Štátny ústav pre kontrolu liečiv (ŠÚKL)** |
Country Recognized June 26, 2019
| Country | Regulatory authority for medicinal products for human use* |
|---|---|
| Germany | Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (ZLG) |
Countries 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) |
Countries 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 |
Countries 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) |
Country Recognized November 28, 2018
| Country | Regulatory authority for medicinal products for human use* |
|---|---|
| Estonia | State Agency of Medicines / Ravimiamet |
Countries 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 |
Country 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 |
Countries 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 |
Countries 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 |
Countries 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
- USTR Signs Mutual Recognition Agreements with the United Kingdom- 02/14/2019
- Mutual Recognition Agreement
- 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.