Lead Story
European Commission targets high-risk AI with new draft guidelines
The European Commission has published draft guidelines to help developers determine whether their artificial intelligence (AI) qualifies as ‘high-risk’ under Article 6 of the AI Act. For developers of AI-enabled medical devices, the stakes are particularly high.
Industry news
The HMA-EMA NDSG publishes report on AI in medicines development
Industry is bringing artificial intelligence (AI) to EU medicines regulators faster than ever before, with the number of new AI applications discussed with applicants as part of regulatory procedures having risen sharply, according to a new report by the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA).
MHRA releases AI Airlock Phase 2 programme report
The AI Airlock Phase 2 Programme Report has been published by the MHRA, providing information on the insights and subsequent recommendations from Phase 2 of the initiative.
The National Commission into the Regulation of AI in Healthcare releases survey findings
A summary of the findings from the UK National Commission into the Regulation of Artificial Intelligence in Healthcare’s Call for Evidence has been published, which highlights the need for a significant overhaul of the current framework.
EMA recommends marketing authorisation extension for Wegovy tablets
The European Medicines Agency (EMA) has endorsed an extension to the marketing authorisation of Wegovy (semaglutide) in the EU for weight management. The extension enables the use of tablets, making it the first glucagon-like peptide (GLP-1) receptor agonist for weight management developed for oral use.
Harmonisation, fast track and reliance activities in focus at recent EDQM meetings
Leaders from the European Directorate for the Quality of Medicines & HealthCare (EDQM), which is home to the European Pharmacopoeia (PhEur), participated in two public outreach events in May 2026. The first was on pharmacopoeial harmonisation in collaboration with United States Pharmacopoeia (USP), and the second on fast track and ...
EMA launches pilot to support breakthrough medical devices
The European Medicines Agency (EMA) has launched a pilot programme to support the development of breakthrough medical devices in the EU. This tests a new regulatory pathway that supports patient access to highly innovative technologies while maintaining rigorous safety and performance standards and will offer enhanced support for ...
More news
Gene therapies, first-in-class medicines and label updates: CHMP delivers a busy April session
MHRA publishes draft 2026 medical device regulations for GB market
CVMP advances discussions on AMR and quality guidance
Clinical trials amendment regulations to take effect from 28 April 2026
FDA advances commitment to moving beyond animal testing
ACT EU issues draft guidance on clinical trials during emergencies
FDA launches new consolidated adverse event reporting system
