EU regulator calls for regulatory overhaul in first AI Observatory report

The European Medicines Agency has called for updated rules and processes to reflect growing use of artificial intelligence in medicines regulation, following the release of the first annual report from its AI Observatory.

The European medicines regulatory network launched the Observatory to monitor and share developments in AI and ensure regulators are equipped to respond. The newly published report outlines how AI tools are being adopted internally and signals that the current regulatory framework is not fully equipped to handle the pace of change.

The report details how EMA is already testing generative AI tools to support productivity, and has put several AI systems into operational use. These include tools that automate document comparisons and remove personal data from submissions.