europe updates on medical device regulation and quality.
258 articles
Swissmedic, Switzerland’s authority for therapeutic products, has announced the self-declaration deadline for the 2025 oversight fee. Medical device manufacturers, clinical…
On December 5, 2025, Swissmedic announced an extension to the therapeutic indication for Jemperli®, emphasizing its crucial role in the…
On December 5, 2025, Swissmedic published an update regarding the therapeutic indication of Tevimbra®. This regulatory decision expands the scope…
Swissmedic, the Swiss Agency for Therapeutic Products, has officially announced the approval of an extended therapeutic indication for Tevimbra®. This…
Swissmedic has issued an important update regarding Rhophylac® (human anti-D immunoglobulin), alerting healthcare professionals of a contamination risk associated with…
Swissmedic, Switzerland’s medical regulatory authority, has announced an extension of the approved therapeutic indication for the cancer treatment Welireg®. This…
Swissmedic, Switzerland’s key authority for the oversight of therapeutic products, has recently issued a call for an experienced Software Architect…
Swissmedic, Switzerland’s authority for medical devices and therapeutic products, announces an exciting cloud engineering position. Key stakeholders in clinical, quality,…
Effective December 1, 2025, Swissmedic, Switzerland’s therapeutic products regulator, has announced a significant change to its packaging guidance for human…
Swissmedic has issued a temporary approval enabling the distribution of Opdivo 240 mg/24 ml concentrate for infusion solution in Italian-language…
Swissmedic has announced the temporary authorization of Nemluvio—or Nemluvio Pulver und Lösungsmittel zur Herstellung einer Injektionslösung im Fertigpen—for distribution within…
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) convened its Assembly meeting in Singapore…