EMA and the Heads of Medicines Agencies (HMA) have published high-level principles and recommendations for all staff across the European medicines regulatory network (EMRN) using large language models (LLMs) in their work.

LLMs are a category of generative AI, whose applications can significantly support medicine regulators in their tasks and processes. Whether they are used to query the extensive documentation regulators routinely receive, to automate knowledge/data mining processes, or as virtual AI assistants in everyday administrative tasks – LLMs have enormous transformative potential.

However, LLMs also present challenges, e.g. variability in results, returning of irrelevant or inaccurate responses (so-called hallucinations), and potential data security risks. The purpose of the guiding principles is to build understanding of the capabilities and limitations of these applications among staff at regulatory agencies across the EU so that they can harness the potential of LLMs…