6 November 2025
From the Swissmedic newsfeed, Arex Advisor has rounded up a selection of highlights from October 2025.
Swissmedic to introduce Clarification Meeting after preliminary decisions
1 October 2025
Following a successful pilot launched on 1 June 2024, Swissmedic will formally introduce the Clarification Meeting procedure for human medicinal products on 1 October 2025. The meeting provides applicants with an opportunity to discuss Swissmedic’s preliminary decision and clarify outstanding issues before the final decision is issued. Read more
Swissmedic strengthens horizon scanning to anticipate regulatory trends
2 October 2025
Swissmedic continuously monitors scientific, regulatory, and technological developments that may affect the regulation of therapeutic products. Through a structured horizon scanning process, the Agency identifies emerging trends early, enabling proactive responses and informed decision-making to address future regulatory challenges. Read more
Swissmedic Journal October
3 October 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
Swissmedic updates policy on participation of patient representatives at congresses
8 October 2025
Swissmedic has reviewed its approach to participation in scientific and professional congresses and will now allow official representatives of patient organisations to be considered exceptions to its general attendance rules. The exemption applies when representatives actively contribute to the event, for instance by giving a presentation or taking part in a panel discussion, recognising the value of patient involvement in a patient-centred healthcare system. Read more
How do these changes affect you?
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