On September 30, 2025, Hikma Farmacêutica (Portugal) S.A issued a notification to the Medicines and Healthcare…
Category: Europe
europe updates on medical device regulation and quality.
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…
Swissmedic Grants Initial Authorisation for VANFLYTA®: Impact on Clinical and Regulatory Practices
Swissmedic has officially authorised VANFLYTA®, marking its initial regulatory approval. This announcement, dated September 30, 2025,…
Critical Updates: Field Safety Notices Issued for Medical Devices (15–19 September 2025)
Healthcare professionals and regulatory teams, please take note. Between 15 and 19 September 2025, a range…
GHWP Announces Voluntary Withdrawal from IMDRF Membership
On June 24, 2025, the Global Harmonization Working Party (GHWP) officially withdrew as a member of…