Regulators in Europe set out vision for AI in medicines data

Artificial intelligence (AI) will play a role in drug development, including the way in which medicines are regulated, according to European experts.

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMAs) have published an AI workplan, setting out their strategy to maximise the benefits of AI while managing the risks.

The plan, which runs to 2028, sees a role for AI in boosting ‘personal productivity, automating processes and systems, increasing insights into data, and supporting more robust decision-making’.

Prepared by the joint HMA-EMA Big Data Steering Group (BDSG), the workplan aims to keep Europe at the forefront of AI in medicines regulation. While this field is developing swiftly, amid much uncertainty, national authorities in several countries have already begun to develop and use AI tools.

Regulators say there are currently four key ways in which AI will shape the future of medicines development.

• Guidance, policy and product support: Actions focus on continuous support to products in development as well as the development and evaluation of appropriate guidance for the use of AI in the lifecycle of a medicine. Preparation to support the implementation of the EU AI Act will begin later this year.
• AI tools and technology: The aim is to identify and provide frameworks across the network of European regulators to use AI tools to increase efficiency, enhance understanding and analysis of data, and support decision-making.
• Collaboration and training: Initiatives are designed to continuously develop capacity and capability of the network, partners and stakeholders to keep ahead of the evolving field of AI.
• Experimentation: The workplan acknowledges the fundamental role of experimentation in accelerating learning and gaining new insights. Several actions are proposed to ensure a structured approach to experimentation across the network.

As AI technology is fast evolving, including the ethical and policy aspects related to it, the BDSG will regularly update the workplan. Regulators, medicine developers, academics, patient organisations and other interested parties will be informed and engaged throughout the implementation of the plan, the EMA said in a statement.