Swissmedic Grants First Authorization for Pylclari®: Key Updates for Regulatory Teams
On November 14, 2025, Swissmedic officially announced the first regulatory authorization of Pylclari®, marking an important step in medical device…
Switzerland
Switzerland updates on medical device regulation and quality.
156 articles
156 articles in Switzerland
Europe
Europe
Swissmedic Announces Enhanced Use of Enhertu® for Extended Therapeutic Indications
Swissmedic, Switzerland’s regulatory authority for therapeutic products, has announced the authorization of an extended therapeutic indication for Enhertu®. This update…
Europe
Swissmedic Opens Dynamic Role in Information & Documentation Services
Swissmedic has announced a compelling opportunity for professionals within clinical, quality, and regulatory sectors. The agency is recruiting for the…
Europe
Swissmedic Reports Adverse Events from Immunization in 2024: Key Insights
On November 5, 2025, Swissmedic released a comprehensive annual report detailing adverse events following immunization (AEFI) in Switzerland during 2024.…
Europe
Regulatory Update: Swissmedic Confirms Morphinum Capsule Integrity Issues
On November 10, 2025, Swissmedic issued an important notification regarding Sevre-Long® (morphinum), a prescription medication commonly used for pain management.…
Europe
Swissmedic Issues Recall for Amoxicillin OrPha 1g Due to Quality Concerns
Swissmedic has announced a recall of batch B323BE of Amoxicillin OrPha 1g powder for injection or infusion. The recall affects…
Europe
First Swissmedic Authorisation for KIMMTRAK®: A Key Milestone in Oncology Therapy
Swissmedic has released a pivotal regulatory announcement regarding the authorisation of KIMMTRAK®, marking its first approval for clinical use. This…
Europe
Swissmedic Announces Extension of Indication for Retsevmo®: Regulatory Update
On November 7, 2025, Swissmedic officially announced the extension of the therapeutic indication for Retsevmo®, a key development for clinical,…
Europe
Swissmedic Annual Report: GCP Inspections in Clinical Trials Highlight Key Compliance Areas
Swissmedic has released its annual report detailing the results of clinical trial inspections conducted as part of Good Clinical Practice…
Europe
Swissmedic Approves PulmoProDiff®: A Notable Step in Respiratory Diagnostics
Swissmedic has announced the official authorisation of PulmoProDiff®, marking a critical milestone in respiratory diagnostic technology. Clinical, regulatory, and quality…
Europe
Swissmedic Reaffirms Titanium Dioxide Use in Medicinal Products
On November 5, 2025, Swissmedic announced that titanium dioxide will remain authorized as an excipient for use in medicinal products…
Europe
Swissmedic Opens Bids for Advanced Document and Records Management System: A Regulatory Update
On November 3, 2025, Swissmedic, the Swiss agency for therapeutic products, announced its initiative to procure a state-of-the-art Document and…
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