europe updates on medical device regulation and quality.
258 articles
Swissmedic, Switzerland’s regulatory authority for therapeutic products, has announced the authorization of an extended therapeutic indication for Enhertu®. This update…
Sun Pharma UK Limited has issued a precautionary recall of specific batches of their Atorvastatin 20mg and 80mg film-coated tablets.…
Swissmedic has announced a compelling opportunity for professionals within clinical, quality, and regulatory sectors. The agency is recruiting for the…
On November 5, 2025, Swissmedic released a comprehensive annual report detailing adverse events following immunization (AEFI) in Switzerland during 2024.…
Zambon SpA has issued a recall of its Emylif 50mg orodispersible film as a precautionary measure following stability testing concerns.…
On November 10, 2025, Swissmedic issued an important notification regarding Sevre-Long® (morphinum), a prescription medication commonly used for pain management.…
Swissmedic has announced a recall of batch B323BE of Amoxicillin OrPha 1g powder for injection or infusion. The recall affects…
Swissmedic has released a pivotal regulatory announcement regarding the authorisation of KIMMTRAK®, marking its first approval for clinical use. This…
On November 7, 2025, Swissmedic officially announced the extension of the therapeutic indication for Retsevmo®, a key development for clinical,…
Swissmedic has released its annual report detailing the results of clinical trial inspections conducted as part of Good Clinical Practice…
Swissmedic has announced the official authorisation of PulmoProDiff®, marking a critical milestone in respiratory diagnostic technology. Clinical, regulatory, and quality…
On November 5, 2025, Swissmedic announced that titanium dioxide will remain authorized as an excipient for use in medicinal products…