EMA Publishes Guide for Use of AI in Medicine Regulation

The European Medicines Agency (EMA) announced on Dec. 18, 2023 that it has, along with the Heads of Medicines Agencies (HMAs), published a strategy for coordinating the use of artificial intelligence (AI) in medicines regulation. The Multi-annual AI Workplan 2023–2028 was developed by the HMA-EMA Big Data Steering Group (BDSG) to coordinate a strategy to best use the benefits of AI and minimize any risks associated with its use and help the European medicines regulatory network (EMRN) to utilize AI for the automation of processes and evaluating data.

“The increasingly sophisticated nature and the pace of change of AI bring opportunities but also challenges. The application of AI requires a collaborative, coordinated strategy to maximize the benefits from AI while ensuring that uncertainty is adequately explored, and risks are mitigated,” the document states.

The workplan focuses on four key elements:

• Guidance, policy, and product support. The plan will give support for products in development and for guidance in development regarding the use of AI in a drug’s lifecycle. Preparations for the implementation of the EU AI Act will begin in 2024.
• AI tools and technology. Frameworks will be identified and provided for the use of AI tools for data analysis and decision-making.
• Collaboration and training. Initiatives will be created to develop capacity and capability of the EMRN, partners, and stakeholders.
• Experimentation. Actions will ensure a structured approach to accelerated learning of AI.

“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 organizations, and other interested parties will be informed and engaged throughout the implementation of the plan,” EMA stated in a press release.

Source: EMA