The increasing relevance of artificial intelligence (AI) in the regulatory field has been acknowledged by the publication of a draft reflection paper describing EMA’s current views on the use of AI and machine learning (ML). The draft reflection paper is open to public consultation up to 31 December 2023; it 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. The document discusses possible uses of AI and ML along the entire life cycle of medicinal products.

For example, AI/ML modelling approaches might be of help in reducing the need of animal studies in preclinical development, or the selection of patients to be recruited for clinical trials. AI/ML may also support the analysis of data to be included in regulatory dossiers. In the post-marketing phase, they may prove useful to support adverse event report management and signal detection. According to the reflection paper, a human-centric approach should guide all development and deployment of AI and ML. The use of AI in the medicinal product lifecycle should always occur in compliance with the existing legal requirements, consider ethics and ensure due respect of fundamental rights.