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Switzerland Mutual Recognition Agreement

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On January 12, 2023, the FDA signed an MRA with Switzerland. The MRA entered into force on July 27, 2023, after the FDA determined whether Switzerland was capable of conducting inspections that met U.S. requirements, and the Swiss Agency for Therapeutic Products (Swissmedic), made a similar determination with respect to the FDA meeting Swiss requirements. 

FDA also has MRAs in force with the European Union and the United Kingdom

Country Regulatory authority for medicinal products for human and/or veterinary use* Type Date Recognized
Switzerland Swissmedic - Swiss Agency for Therapeutic Products/Schweizerisches Heilmittelinstitute

Human Drugs

Animal Drugs

July 26, 2023
United States Food and Drug Administration

Human Drugs

Animal Drugs

July 18, 2023

*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

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



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