The mutual recognition of GMPs inspections fo pharmaceutical manufacturing facilities between the US and the Swiss Confederation has been established by the signature on 12 January 2023 of a Mutual Recognition Agreement (MRA). The new agreement will allow the two regulatory agencies, the FDA for the US and Swissmedic for Switzerland, to reciprocally use each other’s results of GMP inspections, thus avoiding the need duplicate activities. The agreement – that includes both human and veterinary medicines – is based on the Food and Drug Administration Safety and Innovation Act of 2012, according to which the FDA may enter into agreements to recognise drug inspections conducted by foreign regulatory authorities determined to be capable of conducting inspections that meet US requirements. The entry into force of the MRA shall be preceded by the mutual determination of the capacity of the respective regulatory agencies to conduct inspections that meet each other’s requirements. The FDA already has MRAs in place with the EU and UK, while Switzerland has signed MRA agreements with the EU, Canada and EFTA.