5 September 2024 – The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have established guiding principles for integrating large language models (LLMs) into the European Medicines Regulatory Network (EMRN), effective immediately. These guidelines are designed to ensure that LLMs, which offer significant potential for enhancing regulatory tasks through data analysis and automation, are used safely and effectively. The principles address key aspects such as secure data handling, accurate output verification, and the need for continuous staff training. They also stress the importance of developing governance frameworks and defining specific use cases for LLMs.

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