MRA GMP Switzerland - USA

Medicine manufacturers in Switzerland and the United States have to comply with the standards of good manufacturing practice (GMP). The GMP rules are agreed at international level (PIC/s). They ensure that products are manufactured and continuously monitored according to the quality requirements aimed at patient safety. These rules must be followed during manufacture as a precondition for the approval of medicines by the national regulatory authorities. Pharmaceutical production facilities are periodically inspected by the certifying authorities, i.e. Swissmedic in Switzerland and the US Food and Drug Administration (FDA) in the United States.

In January 2023, Switzerland and the US signed an agreement on the mutual recognition of inspections in relation to good manufacturing practice (GMP) for medicinal products, meaning that each country accepts the inspections carried out by the other's regulatory authority. This avoids the need for duplicate inspections of production facilities, thereby saving both time and money..

The MRA is based on the two authorities' mutual recognition of each other's inspections. Before it could come into force, a mutual assessment of each authority's procedures had to be carried out. Following the positive outcome of the assessment between Swissmedic in Switzerland and the FDA in the United States, the agreement entered into effect on 27 July 2023.

The agreement is intended to facilitate trade in medicinal products and reduce the administrative and financial burden for both the industry and the respective authorities. In doing so, it also helps strengthen global value chains and secure the supply of medicinal products.

Implementation of the GMP agreements in Switzerland is the responsibility of Swissmedic.


Specialist staff
Last modification 09.01.2024

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