AI in lifecycle of medicines: a reflection paper by EMA

The European Medicines Agency has published a draft reflection paper outlining 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.

The paper, which is now open for public consultation, reflects on principles relevant to the application of AI and machine learning (ML) at any step of a medicine’s lifecycle, from drug discovery to the post-authorisation setting.

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, for example, AI/ML modelling approaches to replace, reduce, and refine the use of animal models during preclinical development.

  • In clinical trials, AI/ML systems may support the selection of patients based on certain disease characteristics or other clinical parameters; such tools can also support data recording and analyses which will in turn be submitted to regulators 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 product information of a medicine.
  • In the post-authorisation phase, such tools can effectively support, for example, pharmaco vigilance activities including adverse event report management and signal detection.

This range of applications brings with it challenges such as the understanding of the algorithms, notably their design and possible biases, as well as the risks of technical failures and the wider impact these would have on AI uptake in medicine development and health.

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

This work 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. 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.