The European Medicines Agency (EMA) has adopted a reflection paper (RP) on using artificial intelligence (AI) in drug development after considering feedback from scores of stakeholders who asked for clarifications and more information on the document’s scope during the consultation period. The agency said the updated paper also includes changes based on the recent EU AI Act.
On 30 September, EMA announced that its Committee for Medicinal Products for Human Use (CHMP) Methodology Working Party drafting group had reviewed the feedback on its AI reflection paper from 66 stakeholders, including regulatory bodies and public consortia. Based on the 1,342 comments received, the agency has decided to update key parts of the paper. (RELATED: EMA details lifecycle approach to AI/ML drug development in new reflection paper, Regulatory Focus 20 July 2023)…
