Essential MHRA Updates: August 2025 Safety Guidance for Medicines and Medical Devices

The Medicines and Healthcare products Regulatory Agency (MHRA) has released its latest safety advice for August…

Review and Provide Feedback on IMDRF Regulatory Updates from the 24th Management Committee Session

The International Medical Device Regulators Forum (IMDRF) has announced updates from its Working Groups, which are…

Medical Device Field Safety Notices: Updates from August 25–29, 2025

Field Safety Notices issued between August 25 and 29, 2025, provide crucial updates for stakeholders involved…

IMDRF’s Safety and Performance Workshop: Key Insights for Regulatory Professionals

The International Medical Device Regulators Forum (IMDRF) held a two-part workshop on September 11 and September…

Profemur Modular Neck Hip Implants: Heightened Risk of Fractures and Revision Surgery Identified

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an important update regarding the risks…

IMDRF Digitalizes Membership Applications: New Online Platform Launches

Clinical, quality, and regulatory teams take note: Starting May 2025, the International Medical Device Regulators Forum…

Scemblix® Gains Extended Therapeutic Indication Approval from Swissmedic

Swissmedic has officially announced an extension of the therapeutic indications for Scemblix®, a drug that plays…

Regulatory Alert: Patient Information Leaflet Defect for Hikma Farmacêutica’s Gemcitabine 2g/52.6ml Infusion Concentrate

On September 30, 2025, Hikma Farmacêutica (Portugal) S.A issued a notification to the Medicines and Healthcare…

Regulatory Update: Swissmedic Confirms Safety of Paracetamol Use During Pregnancy

Swissmedic, Switzerland’s regulatory authority for therapeutic products, has reaffirmed its position on the use of medicines…

Critical Updates: Field Safety Notices Issued from 8–12 September 2025

Important updates for clinical, quality, and regulatory teams: A series of Field Safety Notices (FSNs) were…