Switzerland: GMP Compliance by Foreign Manufacturers

In Switzerland, the Swissmedic has been in direct discussions with industry associations regarding possible simplifications in the assessment of GMP compliance by foreign manufacturers and has clarified outstanding issues.

An extraordinary GMP/GDP roundtable held on 13 August 2026 focused on the GMP compliance of foreign manufacturers in the context of marketing authorisation applications, as well as on possible joint and concrete solutions and approaches.

The aim is to simplify procedures and make them more efficient. Given the importance of the topic, Swissmedic has, as an exception, published the minutes of the roundtable.

The Swissmedic provided information on the new provisions and clarifications regarding evidence for verifying the GMP compliance of foreign manufacturers. Examples of current grounds for rejection were cited, and up-to-date approaches were presented.

The industry presented the current situation, current challenges and its feedback from practical experience. The focus was particularly on implementation issues, existing ambiguities, the impact on the companies concerned and the increasing challenges in the current political and regulatory environment.

Further details can be found in the press release and the meeting minutes (only available in German).