FDA: Mutual Recognition Agreement with Swissmedic
On 12 January 2023, the FDA signed a Mutual Recognition Agreement between the United States and Switzerland, allowing the FDA and Swissmedic to share each other's GMP inspectional findings, which will reduce unnecessary costs and duplicative efforts.
In addition to the FDA and Swissmedic, the agreement was also signed by the Office of the U.S. Trade Representative and Switzerland’s State Secretariat for Economic Affairs.
The FDA already has MRAs in place with the EU and the UK. The MRA with Swissmedic includes human and veterinary medicines. It is not yet in force as the FDA must determine whether Swissmedic is capable of conducting inspections that meet U.S. requirements, while Swissmedic must undergo a similar determination with respect to the FDA meeting Swiss requirements.
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