On October 10, 2025, Swissmedic issued its first authorization for Balversa®, marking a significant milestone in…
Category: Europe
europe updates on medical device regulation and quality.
Swissmedic Approves Extended Use for Spevigo®: Important Regulatory Update
Swissmedic has officially approved an extension of the therapeutic indication for Spevigo®. This regulatory decision marks…
Swissmedic Grants Initial Authorization for Voxzogo®: A Milestone for Regulatory Compliance
Swissmedic, the Swiss agency for therapeutic products, has officially granted the first authorization for Voxzogo®, marking…
Swissmedic Announces First Authorization for Blenrep®
Swissmedic has officially announced the first authorization of Blenrep®, marking a significant regulatory milestone in its…
Swissmedic Opens Recruitment for Financial Leadership Role in Compliance-Focused Environment
Swissmedic, Switzerland’s authority responsible for the authorization and monitoring of therapeutic products, has announced a new…
Swissmedic Opens Clinical Assessor Positions: A Vital Role in Regulatory Oversight
Swissmedic has officially announced openings for Clinical Assessors within its Division of Clinical Assessment, offering employment…
Swissmedic Issues Recall for Select Batches of ASS Cardio Spirig HC 100 mg Film-Coated Tablets
On October 8, 2025, Swissmedic issued an immediate recall for specified batches of ASS Cardio Spirig…
Swissmedic Updates Guidelines on Professional Advertising at Events with Patient Representatives
Swissmedic has announced a significant update regarding professional advertising practices during medical education events, particularly those…
Safety Update: Key Field Notices Issued in Early October 2025
Between 29 September and 3 October 2025, critical updates were released regarding medical device safety compliance.…
Swissmedic Advisory: Safety Update for Tegretol 2% Oral Suspension Containing Propylene Glycol
Swissmedic has issued an important safety advisory regarding Tegretol 2% oral suspension, which contains propylene glycol.…