The EMA has published guiding principles that set how EU medicine regulators can use large language models (LLMs), a form of generative AI, focusing on text generation in regulatory science and for regulatory activities.

Artificial intelligence is a general term referring to any machine-based system designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments.

The document provides high-level recommendations to facilitate LLMs’ safe, responsible, and effective use, being of interest to anyone who uses or would like to use such AI models in the future.