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United Kingdom (UK) Mutual Recognition Agreement

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The U.S.-UK Mutual Recognition Agreement (MRA) Sectoral Annex for Pharmaceutical Good Manufacturing Practices (GMP) entered into force on January 1, 2021. Initially the agreement included only pharmaceuticals intended for human use. On September 27, 2021, the U.S. Food and Drug Administration (FDA) and the United Kingdom’s Veterinary Medicines Directorate (VMD) announced their decision to expand the scope of the MRA to include inspections of veterinary pharmaceuticals. 

FDA also has MRAs in force with the European Union and Switzerland. 

Country Regulatory authority for medicinal products for human and/or veterinary use* Type Date Recognized
United Kingdom Veterinary Medicines Directorate Animal Drugs September 24, 2021
United Kingdom Medicines and Healthcare products Regulatory Agency Human Drugs November 1, 2017
United States Food and Drug Administration

Human Drugs

Animal Drugs

November 1, 2017

September 27, 2021

*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. 

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

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