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Please note this is an extract of the original bulletin.

MRA between Switzerland and the USA on the manufacturing practice for medicinal products takes effect

Mutual recognition in principle of inspections by Swissmedic and the FDA. 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).