EMA Urges Regulatory Updates Amid Rising AI Use In Medicines Oversight

In its first annual report from the artificial intelligence (AI) Observatory, the European Medicines Agency (EMA) has urged a review of existing regulatory processes to reflect the growing role of artificial intelligence in medicines regulation.

The AI Observatory, set up by the European medicines regulatory network, is designed to track AI developments and support regulatory readiness. The report highlights that while AI tools are being adopted internally, existing frameworks may not be adequate to address the speed of technological change. The EMA is currently testing generative AI tools to improve productivity and has implemented several AI systems, such as document comparison and anonymisation tools.

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