Artificial intelligence workplan to guide use of AI in medicines regulation

18 December 2023

EMA and the Heads of Medicines Agencies (HMAs) have published an artificial intelligence (AI) workplan to 2028, setting out a collaborative and coordinated strategy to maximise the benefits of AI to stakeholders while managing the risks.

The workplan will help the European medicines regulatory network (EMRN) to embrace the opportunities of AI for personal productivity, automating processes and systems, increasing insights into data and supporting more robust decision-making to benefit public and animal health.

The AI workplan, prepared under the joint HMA-EMA Big Data Steering Group (BDSG), ensures the EMRN remains at the forefront in benefiting from AI in medicines regulation. The workplan was adopted by EMA’s Management Board at its December meeting.

The field of AI is developing swiftly. Pharmaceutical companies increasingly use AI-powered tools in research, development and monitoring of medicines. National competent authorities are responding to the new opportunities and challenges by starting to use and develop AI tools. The workplan focuses on four key dimensions:

• 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. Work has already begun with the ongoing public consultation on the AI reflection paper, open until the end of December 2023. Furthermore, in 2024 preparations to support the implementation of the EU AI Act will start.
• AI tools and technology: The aim is to identify and provide frameworks across the network to use AI tools to increase efficiency, enhance understanding and analysis of data and support decision-making. Full compliance with data protection legislation will be ensured.
• 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.