On November 7, 2025, Swissmedic officially announced the extension of the therapeutic indication for Retsevmo®, a…
Category: Europe
europe updates on medical device regulation and quality.
Swissmedic Annual Report: GCP Inspections in Clinical Trials Highlight Key Compliance Areas
Swissmedic has released its annual report detailing the results of clinical trial inspections conducted as part…
Swissmedic Approves PulmoProDiff®: A Notable Step in Respiratory Diagnostics
Swissmedic has announced the official authorisation of PulmoProDiff®, marking a critical milestone in respiratory diagnostic technology.…
Swissmedic Reaffirms Titanium Dioxide Use in Medicinal Products
On November 5, 2025, Swissmedic announced that titanium dioxide will remain authorized as an excipient for…
Key Updates in Field Safety Notices: Impact on Medical Devices and Compliance
Between 27 and 31 October 2025, several Field Safety Notices (FSNs) were issued, highlighting critical updates…
Swissmedic Opens Bids for Advanced Document and Records Management System: A Regulatory Update
On November 3, 2025, Swissmedic, the Swiss agency for therapeutic products, announced its initiative to procure…
Swissmedic Publishes November Safety Updates for Healthcare Professionals
Swissmedic has issued new safety-related updates this November 2025, designed to inform healthcare professionals and regulatory…
Swissmedic Updates Key Information on Drug Safety Reporting – What You Need to Know
Swissmedic has announced an update to its Drug Safety Reporting Duties in Switzerland information sheet. The…
Swissmedic Updates Signal Management Guidance in PSUR Reporting
Swissmedic has released an update to its guidance document regarding the Authorisation PSUR Signal Management TAM…
Urgent Recall Alert: Baxter Healthcare’s Hartmann’s Solution Packaging Mix-up
Baxter Healthcare Limited has issued a Class 2 medicines recall after identifying a packaging error involving…