Swissmedic Updates Guidance on GMP Compliance of Foreign Manufacturers
Swissmedic has revised its guidance document “GMP compliance by foreign manufacturers”. The new Version 7.0 has been valid since 7 September 2026. In particular, it introduces new provisions for demonstrating the GMP compliance of manufacturers inspected by the US FDA.
Two new sections have been added for manufacturers of active substances and finished medicinal products, respectively. Under certain conditions, an FDA inspection report or specific documents issued by the FDA may be submitted as evidence of GMP compliance. These include a valid Certificate of Pharmaceutical Product (CPP), a cGMP Declaration or a valid cGMP Certificate.
Swissmedic has also clarified the requirements for GMP certificates and supplemented the provisions concerning the use of inspection reports issued by recognised authorities. Further clarifications concern the documents to be submitted and the accepted document languages.
Source:
Swissmedic: Guidance document GMP compliance by foreign manufacturers
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