Swissmedic has announced the temporary authorization of Nemluvio—or Nemluvio Pulver und Lösungsmittel zur Herstellung einer Injektionslösung…
Category: Europe
europe updates on medical device regulation and quality.
International Council for Harmonisation Convenes: Regulatory Updates for Pharmaceuticals Highlighted
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) convened its…
Medicine Safety Alert: Baclofen 10mg Tablets Missing Correct Patient Safety Information
A safety advisory has been issued for Baclofen 10mg tablets, manufactured by Special Concept Development UK…
Regulatory Update: MHRA Highlights November 2025’s Key Safety Insights for Medicines and Devices
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued its latest safety roundup for November…
Important Patient-Level Recall: Algifor Junior Suspension 200 ml and Algifor Dolo Junior Suspension 200 ml
Swissmedic issues a patient-centric recall for specific batches of Algifor Junior Suspension 200 ml and Algifor…
Swissmedic Announces New Therapeutic Indication for Tepkinly®
Swissmedic has announced an update to the therapeutic indications for Tepkinly®. This regulatory approval marks an…
Swissmedic Approves Enhertu® for Extended Therapeutic Indications
Swissmedic has granted authorization for the extension of therapeutic indications for Enhertu® as of November 28,…
Temporary Authorization Alert: Ringerfundin B. Braun Infusion Solution Distribution Update
Swissmedic, the Swiss Agency for Therapeutic Products, has granted a temporary approval for the distribution of…
Swissmedic Spotlights Personnel Roles: Essential Update for Teams
On November 28, 2025, Swissmedic released details regarding changes in personnel requirements within its Abteilung Personal…
Swissmedic Announces HR Business Partner Opening: A Strategic Role in Regulatory Support
Swissmedic, the Swiss Agency for Therapeutic Products, has announced an exciting job opportunity for an HR…