On November 26, 2025, Swissmedic announced the temporary approval for distribution of NaCl 0.9% infusion solution…
Category: Europe
europe updates on medical device regulation and quality.
Critical Updates: Field Safety Notices Issued for Medical Devices (Nov 17–21, 2025)
New updates on medical device safety concern all clinical, quality, and regulatory professionals. Between November 17…
Important Safety Notice: Updated Safety Information Missing from Moclobemide 150mg Tablets Packaging
On November 25, 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) issued a Class 4…
Swissmedic Announces Financial Consolidation Plan Amid Regulatory Priorities
Swissmedic, Switzerland’s key regulatory authority for therapeutic products, has outlined measures to strengthen its financial position.…
Critical Updates: Field Safety Notices Issued from 10–14 November 2025
Between 10 and 14 November 2025, significant Field Safety Notices (FSNs) were announced, carrying potential implications…
Swissmedic Confirms First Authorisation for Lutathera®: Key Regulatory Update
On November 22, 2025, Swissmedic published an important regulatory update announcing the first authorisation of Lutathera®,…
Swissmedic Expands Use of Breyanzi®: Updated Authorization Details
On November 22, 2025, Swissmedic announced the extension of the therapeutic indication for Breyanzi® (lisocabtagene maraleucel).…
Swissmedic Authorizes 18F-PSMA-1007 ZRP®: Key Insights for Regulatory and Clinical Teams
On November 22, 2025, Swissmedic officially granted the first authorization of 18F-PSMA-1007 ZRP®. This approval represents…
Swissmedic Grants First Authorisation of Radelumin®: A Regulatory Milestone
Swissmedic has announced the first authorisation of Radelumin®, marking a significant regulatory achievement. Effective November 22,…
Swissmedic Update: Expanded Indication Approval for NexoBrid®
Swissmedic, Switzerland’s medical regulatory authority, has announced an important update regarding NexoBrid®. On November 22, 2025,…