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.

Country Recognized July 11, 2019

Country Recognized June 26, 2019

Countries Recognized June 10, 2019

Countries Recognized April 29, 2019

Countries Recognized February 7, 2019

Country Recognized November 28, 2018