Paper outlines EMA's early thoughts on AI

19 July 2023

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The European Medicines Agency (EMA) has published a draft reflection paper outlining the current thinking on the use of artificial intelligence (AI) to support the safe and effective development, regulation and use of medicines.

This paper, which is now open for public consultation, reflects on principles relevant to the application of AI and machine learning (ML) at any step of a medicine’s lifecycle, from drug discovery to the post-authorization setting.

The paper is part of the joint HMA-EMA Big Data Steering Group (BDSG) initiatives to develop the European Medicines Regulatory Network’s capability in data-driven regulation.

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