FDA signs MRA with Switzerland

Recommendation

14-16 June 2023
Copenhagen, Denmark

The GMP-Auditor
Initial and Continuous Professional Training for GMP Auditors

The FDA has signed a so-called Mutual Recognition Agreement (MRA) with Switzerland on the mutual recognition of good manufacturing practice for medicinal products.

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.

However, before the MRA enters into force, the FDA must determine whether Swissmedic is able to carry out inspections that meet US requirements (and vice versa).

In addition to the FDA and Swissmedic, the Office of the U.S. Trade Representative and the State Secretariat for Economic Affairs of Switzerland have 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.