Use of Artificial Intelligence (AI) in the medicinal product lifecycle - Scientific guideline

The reflection paper on the use of artificial intelligence in the lifecycle of medicines outlines the current thinking on the use of artificial intelligence (AI) to support the safe and effective development, regulation and use 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.

Keywords: artificial intelligence, AI, machine learning, ML, regulatory, medicine, human medicinal product, veterinary medicinal product

Current version

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

AdoptedReference Number: EMA/CHMP/CVMP/83833/2023

Document history

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

Draft: consultation closedConsultation dates: 19/07/2023 to 31/12/2023Reference Number: EMA/CHMP/CVMP/83833/2023Summary:

EMA is seeking stakeholder feedback on the draft reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle via an open consultation concerning human and veterinary medicines. This consultation aims to initiate the dialogue with all groups of stakeholders in this fast evolving field. During the consultation a workshop will be organised by EMA on 20-21 November 2023 on AI in the context of medicines.

Please provide feedback by 31 December 2023 using the dedicated form.

Implementation of comments received on the draft “Reflection paper on the use of artificial intelligence in the medicinal product lifecycle” (EMA/CHMP/CVMP/83833/2023)

Reference Number: EMA/CHMP/CVMP/83833/2023