Europe

Breaking Swissmedic News: Critical Quality Issue with Arixtra® Fondaparinux Sodium Prefilled Syringe Needles

M6-C Cervical Disc Updates: Monitoring Rules Tightened Over Osteolysis Concerns

The Medicines and Healthcare products Regulatory Agency (MHRA) has introduced new monitoring requirements following a review of risks associated with…

Swissmedic Approves Redundancy Plan for Headcount Reduction

Swissmedic has finalized a redundancy scheme in response to an announced staff reduction at the organization. The plan has been…

Swissmedic Expands Approval for Calquence® Therapeutic Indication

On January 15, 2026, Swissmedic officially approved an extension of the therapeutic indication for Calquence®, marking a significant regulatory development…

Temporary Authorization for Abilify i.m. Injection Solution Due to Supply Shortage

Swissmedic, Switzerland’s authority for therapeutic products, has announced the temporary authorization for the distribution of Abilify i.m. injection solution (7.5mg/ml)…

Swissmedic Confirms New Blood Donation Guidelines to Address vCJD Concerns

On February 1, 2026, new blood donation criteria from Swiss Transfusion SRC will take effect, marking a critical update in…

Swissmedic welcomes Vincenza Trivigno as new Executive Director

On January 12, 2026, Swissmedic, the Swiss agency responsible for the authorization and monitoring of therapeutic products, announced a significant…

Streamline Medical Device Registration with Swissmedic: Free Webinar Highlights swissdamed Tools

Swissmedic, Switzerland’s national agency for therapeutic products, is offering a complimentary webinar on May 28, 2026. This online session will…

December 2025 MHRA Safety Updates: New Guidance for Medicine and Medical Device Users

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued its December 2025 roundup of the latest safety updates for…

Critical Updates: Field Safety Notices from December 22–26, 2025

The latest Field Safety Notices (FSNs) issued between December 22 and December 26, 2025, are now available. These updates are…

Critical Updates: Field Safety Notices Published Between 29 December 2025 and 2 January 2026

The UK Health Authorities have released an updated list of Field Safety Notices (FSNs) covering the period from 29 December…

Regulatory Update: Swissmedic Expands Therapeutic Indication for Jaypirca®

Swissmedic has announced an extension of the therapeutic indication for Jaypirca®, a development that could impact clinical practice and regulatory…