Effective December 1, 2025, Swissmedic, Switzerland’s therapeutic products regulator, has announced a significant change to its…
Category: Regulatory Affairs
Global updates on medical device regulation and quality.
Temporary Approval Announced for Sales of Opdivo 240 mg Infusion Solution in Italian Packaging
Swissmedic has issued a temporary approval enabling the distribution of Opdivo 240 mg/24 ml concentrate for…
Swissmedic Grants Temporary Approval for Nemluvio Injection Pen Packaging in German
Swissmedic has announced the temporary authorization of Nemluvio—or Nemluvio Pulver und Lösungsmittel zur Herstellung einer Injektionslösung…
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…
FDA Issues Serious Correction Notification for BD Alaris Pump Modules Due to Safety Risks
The United States Food and Drug Administration (FDA) has released an updated correction notification for BD…
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,…