Swissmedic: Mutual Recognition Agreement with US FDA in Force
The Mutual Recognition Agreement between Switzerland and the USA signed in January entered into force on 27 July 2023. As already reported, the MRA allows the FDA and the Swissmedic to share and use each other's GMP inspectional findings regarding medicinal products.
Dual inspections at the same site by the FDA and Swissmedic should thus be avoided reducing the workload for the authorities and their costs. In concrete terms, the MRA’s entry into force means that before the FDA conducts an inspection in Switzerland or by Swissmedic in the USA, it will be necessary to check whether the production site in question has already been inspected. If so, GMP documents will be made available to the partner authority subject to consent being given by the manufacturer. These documents can then be used to evaluate the manufacturer instead of conducting an on-site inspection.
In collaboration with the FDA, Swissmedic will optimise the implementation in the coming months and work towards extending the scope to include vaccines.
Source:
Swissmedic: Press releases
Meet the GMP Compliance Adviser
The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business.
The demo access is non-binding and ends automatically.
You may also be Interested in the Following Articles:
