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FDA Signs Mutual Recognition Agreement between US and Switzerland

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Agreement allowing FDA and Swissmedic to share GMP inspectional findings, reducing unnecessary costs and duplicative efforts

The FDA signed the Agreement on Mutual Recognition between the Swiss Confederation and the U.S. Relating to Pharmaceutical Good Manufacturing Practice.

By signing such an agreement the Swiss Confederation (Switzerland), the FDA, and the Swiss Agency for Therapeutic Products (Swissmedic) will be able to utilize each other’s good manufacturing practice inspections of pharmaceutical manufacturing facilities, avoiding the need for duplicate inspections.

Enacted in 2012, the Food and Drug Administration Safety and Innovation Act, permitted the FDA to enter into agreements to recognize drug inspections conducted by foreign regulatory authorities determined to be capable of conducting inspections that meet U.S. requirements. The FDA already has a Mutual Recognition Agreement (MRA) in place with the European Union and one with the UK. In addition to covering good manufacturing practice inspections of facilities making human drugs, the MRA with Swissmedic also includes veterinary drugs.

The FDA’s Office of Global Policy and Strategy has been negotiating the US-Switzerland MRA for several years. Before the MRA enters into force, the FDA must determine whether Swissmedic is capable of conducting inspections that meet US requirements, and
Swissmedic must make a similar determination with respect to the 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. “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.”

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.

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