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

The Federal Council already approved the agreement with the USA for mutual recognition of inspections relating to the manufacture of medicinal products on 16 December 2022. On 12 January 2023, this agreement was signed in Washington, D.C. by delegations from Switzerland and the United States. Subsequently, the two partner authorities – the Food and Drug Administration (FDA) and Swissmedic – scrutinised each other’s processes for monitoring medicinal product manufacturers in their respective countries and found them to be comparable.

The MRA shall guarantee that safe, effective, and high-quality medicinal products will continue to be available to patients in both countries while aiming to avoid dual inspections by the FDA and Swissmedic at the same locations. The State Secretariat for Economic Affairs (SECO) thus welcomed the entry into force of this agreement between the two countries. SECO expects that the MRA will simplify trade in medicines between Switzerland and the USA and reduce the administrative burden on the industry.

In future before an inspection is conducted by the FDA in Switzerland or Swissmedic in the United States, it will be necessary to determine if the production site in question has already been inspected under the terms of the MRA. If so, GMP documents will be made available to the partner authority, pending the manufacturer’s approval. These documents can then be used in lieu of an on-site inspection to evaluate the manufacturer.