MRA between Switzerland and the USA now effective

Recommendation

22/23 May 2024
Bern, Switzerland

The QP in Switzerland
Role, Accountability and Liability of the Responsible Person

The Mutual Recognition Agreement (MRA) between Switzerland and the United States in the area of Good Manufacturing Practice (GMP) for medicinal products signed in January has entered into force with effect from 27 July 2023. In principle each country thus accepts the inspections carried out by the other's regulatory authority (Swissmedic or FDA, as the case may be).

Both authorities are thus able to mutually use GMP inspections and their results in order to avoid duplicate inspections. The FDA has already concluded an MRA with the European Union and one with the United Kingdom. The MRA with Swissmedic covers not only human medicines but also veterinary medicines.

In addition to the FDA and Swissmedic, the Office of the U.S. Trade Representative and the State Secretariat for Economic Affairs of Switzerland had also signed the agreement. The basis is the Food and Drug Administration Safety and Innovation Act enacted in 2012, which allows the FDA to enter into agreements to recognise drug inspections by other surveillance authorities.

The text of the Agreement will shortly be published by the Federal Chancellery.