Lead Story
FAST-EU pilot delivers first results: 70-Day approval timelines prove feasible ahead of Biotech Act
The first results from the (Facilitating and Accelerating Strategic Clinical Trials in the EU (FAST-EU) Pilot programme have been published by the Heads of Medicine Agency (HMA). Initial results indicate strong interest and engagement from stakeholders and the possibility of a 70-calendar-day approval timeline for clinical trial applications, indicating operational ...
Industry news
European Commission publishes first joint clinical assessment under EU HTA regulation
The European Commission released the first joint clinical assessment (JCA) report on 9 June for the orphan medicine tovorafenib (Ojemda®), developed by Ipsen, used to treat paediatric low-grade glioma (a type of brain tumour), after being endorsed by all member states. This marks an important milestone for European cooperation on ...
FDA launches Operation TrialBlazer to accelerate US clinical research
The US Food and Drug Administration (FDA) has announced plans to revitalise clinical research in the USA, as part of a US Department of Health and Human Services (HHS) initiative titled ‘Operation TrialBlazer’. The FDA has proposed multiple actions to achieve this aim, targeting both early- and late-stage clinical development. ...
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.
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.
More news
EMA recommends marketing authorisation extension for Wegovy tablets
Harmonisation, fast track and reliance activities in focus at recent EDQM meetings
EMA launches pilot to support breakthrough medical devices
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
