Swissmedic Publishes November Safety Updates for Healthcare Professionals
Swissmedic has issued new safety-related updates this November 2025, designed to inform healthcare professionals and regulatory teams about important changes…
Switzerland
Switzerland updates on medical device regulation and quality.
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156 articles in Switzerland
Europe
Europe
Swissmedic Updates Key Information on Drug Safety Reporting – What You Need to Know
Swissmedic has announced an update to its Drug Safety Reporting Duties in Switzerland information sheet. The adjustments include revised contact…
Europe
Swissmedic Updates Signal Management Guidance in PSUR Reporting
Swissmedic has released an update to its guidance document regarding the Authorisation PSUR Signal Management TAM process, effective November 1,…
Europe
Swissmedic Grants Initial Authorisation for Filsuvez®: A Key Milestone in Advanced Therapies
Swissmedic, the Swiss agency for therapeutic products, has announced the first authorisation of Filsuvez®, marking a pivotal event in the…
Europe
Swissmedic Announces New Role for Laboratory IT Systems Specialist in OMCL
Swissmedic, Switzerland’s surveillance authority for medicines and medical devices, has disclosed an exciting new opportunity in its Laboratory Department, particularly…
Europe
Swissmedic Authorises New Therapeutic Use for Trecondi®
Swissmedic has announced an update regarding the medication Trecondi®. On October 31, 2025, the regulatory body extended the drug’s therapeutic…
Europe
Swissmedic Grants First Authorisation for SWAN-PSMA-1007®: Key Regulatory Insights
On October 31, 2025, Swissmedic announced the first authorisation of SWAN-PSMA-1007®, marking a significant regulatory milestone. This development is relevant…
Europe
Swissmedic Updates Position Paper on Decentralised Clinical Trials: Key Changes Explained
On October 31, 2025, Swissmedic and swissethics announced an update to their position paper on decentralised clinical trials (DCTs) for…
Europe
Swissmedic Approves Extended Therapeutic Indication for Omvoh®
Swissmedic has announced an important update regarding the therapeutic scope of Omvoh®. The newly approved indication offers enhanced application potential…
Europe
Safety Alert: Recall of NaCl B. Braun Infusion Solution Batch
Swissmedic has issued an announcement regarding the immediate recall of batch number 251347651 of NaCl B. Braun infusion solution. This…
Europe
Swissmedic Expands Therapeutic Indication for Palforzia®
Swissmedic, Switzerland’s agency for the authorization and supervision of therapeutic products, has announced an extension of the therapeutic indication for…
Europe
Swissmedic Announces Authorization of Ayvakyt®: A Clinical Update
Swissmedic, the Swiss agency for therapeutic products, has announced the first regulatory authorization for Ayvakyt®. This marks a significant milestone…
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