A draft reflection paper on the use of artificial intelligence (AI) in the medicinal product lifecycle

We are pleased to inform you that the EMA has published for public consultation a draft reflection paper on the use of artificial intelligence (AI) in the medicinal product lifecycle to support the safe and effective development, use and regulation of human and veterinary medicines. This paper reflects on principles relevant to the application of AI and machine learning (ML) at any step of a medicines’ lifecycle, from drug discovery to the post-authorisation setting.

EMA invites all interested partners and stakeholders to engage in a dialogue on AI in relation to medicines by providing their feedback using this EUSurvey form. The public consultation is open until 31 December 2023.

In addition, during the consultation, a joint HMA/EMA workshop on AI to further discuss the topic will take place on 20-21 November 2023 at EMA. The feedback from partners and stakeholders will be analysed and considered for the finalisation of the reflection paper and future development of guidance as relevant. 

The reflection paper, co-developed by the Big Data Steering Group, the Committee for Medicinal Products for Human Use (and its Methodology Working Party) and the Committee for Veterinary Medicinal Products (CVMP) 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.

For more details, the news announcement and related content are available here.

In case of questions on the paper, please contact AIreflectionpaper@ema.europa.eu