30 September 2025
From the Swissmedic newsfeed, Arex Advisor has rounded up a selection of highlights from September 2025.
Swissmedic shortens timelines for certain authorisation applications
1 September 2025
Swissmedic has updated its guidance on time limits for marketing authorisation applications. The revised rules shorten procedures for medicines with known active substances without innovation (KAS w/o innovation) under Article 13 of the Therapeutic Products Act (TPA). Read more
Swissmedic and swissethics issue guidance on first-in-human trials
1 September 2025
Swissmedic and swissethics have published a position paper outlining key considerations for clinical trials in which medicinal products are tested in humans for the first time. The document highlights specific measures sponsors and trial centres should take to maximise participant protection during planning and conduct. Read more
Swissmedic requests updates on contraception guidance for genotoxic medicines
1 September 2025
Swissmedic has asked marketing authorisation holders to review products with genotoxic potential and, where needed, apply to update the product information. The focus is on clarifying the recommended duration of contraception after treatment ends. Read more
Disposal instructions to be included in patient information
1 September 2025
From 1 September 2025, patient information leaflets will include guidance on the correct disposal of medicines. The measure aims to reduce environmental pollution caused by pharmaceutical residues. medicines and medical devices. Read more
Switzerland publishes Good Practices for endoscope reprocessing
1 September 2025
In September 2025, Switzerland released the Good Practices for the Reprocessing of Flexible, Thermolabile Endoscopes (GPAE), a new reference document for inpatient and outpatient healthcare facilities. The guidance is now available in German and French. Read more
Swissmedic Journal #8/2025 published
4 September 2025
The August 2025 edition of the Swissmedic Journal, the agency’s official monthly periodical, has been released. The issue covers current topics on therapeutic products, regulatory requirements, product risks, and national and international framework conditions, along with announcements on authorisation procedures for medicines and medical devices. Read more
Swissmedic reaffirms safety of paracetamol use in pregnancy
24 September 2025
Swissmedic has reiterated that the benefit–risk balance of paracetamol during pregnancy remains positive. While U.S. authorities are investigating a possible link between paracetamol use in pregnancy and autism in children, Swissmedic emphasises that no scientific evidence has confirmed such an association since the medicine was first authorised. Read more
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