Swissmedic has announced an important update for stakeholders involved in authorisation procedures for human medicinal products.…
Category: Regulatory Affairs
Global updates on medical device regulation and quality.
MHRA’s Latest Safety Guidance: Key Updates for Medical and Device Users – June 2025 Edition
The Medicines and Healthcare products Regulatory Agency (MHRA) has released the latest safety guidance for medication…
Swissmedic Introduces Horizon Scanning Platform to Enhance Regulatory Oversight
Swissmedic has unveiled a new horizon scanning website to improve proactive regulatory measures. This initiative aims…
IMDRF Working Group Updates Open for Feedback: Key Regulatory Insights
The International Medical Device Regulators Forum (IMDRF) has announced the availability of updates from its Working…
Critical Updates on Field Safety Notices Issued Between 16 to 20 June 2025
The UK Government has released a detailed summary of Field Safety Notices (FSNs) issued from 16…
Building Global Capacity for Medical Device Safety: IMDRF Workshop Insights
The International Medical Device Regulators Forum (IMDRF) held a pivotal two-part workshop on 11 and 19…
FDA Reacts to Florida’s Ban on 7-OH Opioid Products: What You Need to Know
Meta description: The FDA addresses Florida’s new restrictions on 7-OH opioid products, discussing implications for clinical…
Regulatory Alert: Recall of Kimmtrak 200 micrograms/mL Due to Potency Issues
Immunocore Limited is urgently recalling specific batches of its Kimmtrak 200 micrograms/mL concentrate for solution for…
IMDRF Launches Online Membership Forms: A Streamlined Submission Process
From May 2025, regulatory professionals and other stakeholders involved with medical device oversight will benefit from…
FDA Greenlights Papzimeos: First Immunotherapy for Recurrent Respiratory Papillomatosis
On October 2, 2025, the U.S. Food and Drug Administration (FDA) announced the approval of Papzimeos,…