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The agreement will be able to let FDA and the Swiss Agency for Therapeutic Products (Swissmedic) utilize each other’s GMP inspections of manufacturing facilities, avoiding the need for duplicate inspections.
FDA signed an agreement on Mutual Recognition between the Swiss Confederation and the United States Relating to pharmaceutical good manufacturing practice (GMP). The agreement will be able to let FDA and the Swiss Agency for Therapeutic Products (Swissmedic) utilize each other’s GMP inspections of manufacturing facilities, avoiding the need for duplicate inspections.
The Food and Drug Administration Safety and Innovation Act, enacted 2012, permits FDA to enter into agreements to recognize drug inspections conducted by foreign regulatory authorities determined to be capable of conducting inspections that meet US requirements. Mutual Recognition Agreements (MRAs) are already in place by FDA with the European Union and the United Kingdom. The MRA with Swissmedic includes veterinary drugs, in addition to covering GMP inspections of facilities making human drugs.
Further, FDA’s Office of Global Policy and Strategy has been negotiating the US-Switzerland MRA for several years. Before the MRA is in control, FDA must determine whether Swissmedic can conduct inspections that meet US requirements. Similarly, Swissmedic must decide with respect to FDA meeting Swiss requirements.
“In today’s global pharmaceutical market, MRAs offer a way for the FDA to work more efficiently and maximize its resources,” said Andi Lipstein Fristedt, FDA deputy commissioner for Policy, Legislation, and International Affairs, who signed the agreement on behalf of the FDA, in a company press release. “Once the MRA enters into force, the FDA will be able to rely on the factual findings of Swissmedic experts in many cases, thus avoiding duplicate inspections and allowing the FDA to expand its inspectional reach.”