The U.S.-EU Mutual Recognition Agreement (MRA) Sectoral Annex for Pharmaceutical Good Manufacturing Practices (GMP) MRA entered into force on November 1, 2017. Initially the agreement included only pharmaceuticals intended for human use. On May 31, 2023 the U.S. Food and Drug Administration (FDA) and the European Union (EU) announced their decision to expand the scope of the MRA to include inspections of veterinary pharmaceuticals. To date, the FDA has completed capability for all 27 of the EU countries' human drug regulatory authorities, and 18 of the EU countries’ veterinary drug regulatory authorities. 

FDA also has MRAs in force with Switzerland and the United Kingdom.

 

*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 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, and veterinary immunologicals.

** Malta – capability for human medicines excludes sterile or aseptically processed drugs and biological products; and nonsterile, 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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