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  4. Mutual Recognition Agreements (MRA)
  1. International Arrangements

Mutual Recognition Agreements (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 force with the European Union, Switzerland, and the United Kingdom.

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