Swissmedic, Switzerland’s key authority for the oversight of therapeutic products, has recently issued a call for…
Category: Europe
europe updates on medical device regulation and quality.
Swissmedic Opens Role for Cloud Engineering Expertise in Medical Device Regulation
Swissmedic, Switzerland’s authority for medical devices and therapeutic products, announces an exciting cloud engineering position. Key…
Swissmedic Updates Guidance: Packaging Leaflets for Healthcare-Only Medicines Optional
Effective December 1, 2025, Swissmedic, Switzerland’s therapeutic products regulator, has announced a significant change to its…
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…
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…