28 August 2025
From the Swissmedic newsfeed, Arex Advisor has rounded up a selection of highlights from July to August 2025.
Swissmedic warns of falsified GLP-1 weight loss products
26 August 2025
Swissmedic has alerted the public to the growing circulation of falsified and unauthorised “GLP-1” weight loss products, which may contain undeclared, harmful, or incorrectly dosed substances. These products, marketed as slimming injections or nutritional supplements, pose serious health risks and often misuse the Swissmedic logo or fake quality marks to mislead consumers. Read more
Medical device registration now available in swissdamed
18 August 2025
The swissdamed platform has launched its new UDI Devices module, allowing registration of medical devices, in vitro diagnostics, as well as systems and procedure packs. Use of the module is currently optional, but will become mandatory from mid-2026. Read more
Switzerland adopts new EU rules on electronic instructions for use
8 August 2025
Swissmedic has implemented the EU Commission’s new regulation on providing electronic instructions for use of medical devices. With the entry into force of Implementing Regulation (EU) 2025/1234, electronic instructions for professional users are now permitted in Switzerland with immediate effect. Read more
International study confirms: Swissmedic's authorisation times are competitive
6 August 2025
A new international study by the Centre for Innovation in Regulatory Science (CIRS) confirms that Swissmedic’s authorisation times for medicines with new active substances remain highly competitive. The agency ranks second globally for scientific assessment speed, just behind Japan, and matches the EMA in overall approval timelines. Many applications were processed via fast-track and international collaboration schemes, further shortening review times. Read more
ICH GCP Guideline E6(R3) coming into effect
23 July 2025
The revised ICH GCP Guideline E6(R3), including the Principles and Annex 1, was adopted internationally on 6 January 2025. These provisions took effect in the EU on 23 July 2025 and will apply in Switzerland from 15 August 2025. Annex 2 is scheduled for separate adoption and will not be implemented in either the EU or Switzerland before early 2026. Read more
How do these changes affect you?
Our experienced specialists are ready to help you navigate the regulatory landscape!
