Switzerland Mutual Recognition Agreement
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.
Resources
- Frequently Asked Questions - Mutual Recognition Agreement
- FDA Mutual Recognition Agreement with Swissmedic Enters Into Force - OGPS Statement - (July 27 2023)
- Agreement on Mutual Recognition between the Swiss Confederation and the United States of America Relating to Pharmaceutical Good Manufacturing Practice, OGPS Statement, January 12, 2023
- Press Release - FDA takes unprecedented step toward more efficient global pharmaceutical manufacturing inspections