5 December 2025
From the Swissmedic newsfeed, Arex Advisor has rounded up a selection of regulatory highlights from November 2025.
Swissmedic reports on 2022–2024 GCP clinical trial inspections
6 November 2025
Swissmedic has published its latest review of Good Clinical Practice inspections, covering activity between 2022 and 2024. The regulator conducted 114 inspections across 139 drug studies, providing oversight of trial quality and compliance with international ethical and scientific standards. Read more
Swissmedic Journal November
7 November 2025
The Swissmedic Journal, published monthly in German and French, offers updates on current topics related to therapeutic products. It covers legal and regulatory developments in medicines and medical devices, safety information, and both national and international framework conditions. The journal also includes official announcements on the receipt, rejection, or withdrawal of marketing authorisation applications and related extensions. Read more (in German)
Swissmedic to publish monthly updates on safety changes to product information
13 November 2025
Swissmedic will begin issuing a monthly summary of safety-relevant updates to professional information – and patient information where applicable – from 13 November 2025. The new process aims to give healthcare professionals and stakeholders clearer, more regular visibility of important safety changes to authorised medicines. Read more (in German)
Swissmedic updates Vigilance News format and publishes new reports
19 November 2025
Swissmedic will begin issuing a monthly summary of safety-relevant updates to Swissmedic has released Edition 35 of Vigilance News, introducing a new format with English-only full articles and multilingual summaries to reflect readership trends. The issue also includes a selection of current safety topics and two anticipated annual reports, offering readers a concise overview of recent pharmacovigilance developments. Read more
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