EMA has published a draft reflection paper on the use of artificial intelligence (AI) to support the safe and effective development, regulation and use of human and veterinary medicines. It reflects on principles relevant to the application of AI and machine learning (ML) at any step of the medicines lifecycle, from drug discovery to the post-authorisation setting.

A public consultation on the draft reflection paper is now open until 31 December 2023 to collect feedback from all stakeholders and to identify opportunities and risks of AI in the field of medicines.

AI and ML tools have the potential to effectively support the acquisition, transformation, analysis and interpretation of data across the medicinal product lifecycle. Their application can include AI/ML modelling approaches to replace, reduce and refine the use of animal models during the preclinical development. In clinical trials, AI/ML systems may support the patients’ enrolment; AI/ML tools can also support data recording and analyses in marketing-authorisation procedures.

At the marketing-authorisation stage, AI applications include tools to draft, compile, translate or review data to be included in the medicine product information. In the post-authorisation phase, such tools can effectively support pharmacovigilance activities including adverse event report management and signal detection.

However, some challenges arise, such as the understanding of the algorithms, notably their design and possible biases, as well as the risks of technical failures.

The reflection paper highlights that a human-centric approach should guide all development and deployment of AI and ML. Moreover, 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.

You can find the reflection paper and the dedicated form here.