Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle

The European Medicines Agency (EMA) has released a draft reflection paper that explores the use of artificial intelligence (AI) throughout the lifecycle of human and veterinary medicines. The paper, open for public consultation, covers the application of AI and machine learning (ML) in various stages, from drug discovery to post-authorisation activities.

AI and ML tools can effectively support data acquisition, transformation, analysis, and interpretation across the entire lifecycle of medicinal products. Jesper Kjær, co-chair of the BDSG acknowledges the regulatory challenges that arise within this evolving ecosystem and emphasizes the need to engage in dialogue with developers, academics, and regulators to fully realize the potential and risks of these innovations. Stakeholders are encouraged to provide feedback on the draft reflection paper and identify opportunities and risks associated with AI in the field of medicines.

View the draft

Recommended on behalf of EASE by Silvia Maina, Italy


Written by: European Medicines Agency