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 EU and the United Kingdom, respectively. On January 12, 2023, the FDA signed an MRA with Switzerland. Before this MRA enters into force, the FDA must determine whether Switzerland is capable of conducting inspections that meet U.S. requirements, and the Swiss Agency for Therapeutic Products (Swissmedic), must make a similar determination with respect to the FDA meeting Swiss requirements. 

 

*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), specific to each agreement

The FDA and the UK have considered the issue of expanding the scope of the MRA to include vaccines and plasma-derived pharmaceuticals for human use, and decided to consider the issue again in July 2025 based on further assessment.

The FDA and the EU have considered the issue of expanding the scope of the MRA to include vaccines and plasma-derived pharmaceuticals for human use.  FDA has decided to consider the issue again in July 2025 based on further assessment. 

Excluded from the MRA scope are: Advanced Therapy Medicinal Products (ATMPs), human blood, human plasma, human tissues and organs, cells (Swissmedic MRA), and veterinary immunologicals.

** Malta – capability for human medicines excludes sterile or aseptically processed drugs and biological products; and non-sterile, highly potent drug products.

*** Slovakia – for human medicines 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.

**** Bulgaria – capability for veterinary products excludes sterile veterinary drug products.

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