5 February 2026
From the Swissmedic newsfeed, Arex Advisor has rounded up a selection of regulatory highlights from the past month.
Revised Annex 7 variation list takes effect from February 2026
6 January 2026
An updated list of variations under Annex 7 of the TPLRO has entered into force as of 1 February 2026, reflecting changes adopted under Articles 21–24 TPO. The revision updates how variations are categorised and handled, with implications for companies managing post-authorisation changes. Read more
Swissmedic offers Scientific GMDP Meetings for GMP and GDP queries
7 January 2026
Swissmedic is offering Scientific GMDP Meetings to companies holding, or applying for, a Swissmedic establishment licence to discuss project-specific questions related to Good Manufacturing Practice and Good Distribution Practice. The meetings provide an opportunity to clarify regulatory expectations early and support compliance during manufacturing and distribution activities. Read more
Swissmedic aligns requirements for integral combination products with EU MDR
21 January 2026
Swissmedic has updated its authorisation requirements for medicinal products that include an integral medical device component to reflect the EU Medical Devices Regulation. The changes clarify expectations for integral combination products, helping applicants ensure compliance when device and medicine elements are assessed together. Read more
Swissmedic findings highlight gaps in medical device market surveillance
30 January 2026
Swissmedic inspected 30 medical device importers in 2025 as part of a targeted market surveillance campaign, testing 232 product samples. The results point to ongoing compliance issues, particularly around formal product verification, importer labelling, and storage and transport conditions, signalling a continued need for regulatory action. Read more
Swiss Pharmacopoeia marks evolution into mandatory quality standard
30 January 2026
Since 1865, the Swiss Pharmacopoeia has evolved from a Latin recipe book for pharmacists into a cornerstone of medicines regulation. Used alongside the European Pharmacopoeia, it now serves as a mandatory reference, underpinning the quality, safety, and uniformity of medicinal products in Switzerland. Read more
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