Guiding principles set out how EU medicine regulators can use LLMs in a safe, responsible and effective manner, 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.
large language models (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 effectively and avoid pitfalls and risks.
The guiding principles cover various aspects of using LLMs, from ensuring safe input of data, to applying critical thinking and cross-checking outputs, to knowing whom to consult when concerns arise. Responsible use of LLMs requires familiarity with the tools. The importance of continuous learning is emphasised to keep pace with the fast-changing field. Additionally, the principles encourage regulatory agencies to make efforts to support their staff in using LLMs. This includes defining governance on the use of LLMs, specifying permitted use cases, providing training and monitoring risks.
The guiding principles are one of the deliverables of the multiannual AI workplan to 2028 by EMA and the Heads of Medicines Agencies (HMA). This workplan guides EMA and the EMRN in their use of AI, maximising the benefits while managing the risks, and facilitating information sharing. The guiding principles are a living document that will be regularly updated, and EMA will introduce it to the network in a webinar on 13 September 2024. This is one of the various events and information sharing opportunities organised in the context of the AI workplan.
