EU Agencies Develop Strategy for Use of Artificial Intelligence in Medicines Regulation

• 27/12/2023
• News

On 18 December 2023, the European Medicines Agency (EMA) and the Member State Heads of Medicines Agencies (HMA) published an Artificial Intelligence (AI) workplan (Workplan) which runs until 2028 and sets out a strategy designed to maximise the benefits of AI for stakeholders while managing the risks (see, attached copy).

In response to the rapid advancement of AI in the pharmaceutical sector, the Workplan focuses on four key areas to promote the development and use of what is referred to as “responsible and beneficial AI”:

• Guidance, policy and product support: the Workplan outlines a commitment to continuous support for products under development and involves establishing and evaluating appropriate AI guidelines for the entire lifecycle of pharmaceutical products. Work is already underway, demonstrated by the ongoing public consultation of a reflection paper on the use of AI in the medicine product lifecycle. Furthermore, starting in 2024, various initiatives will be launched to aid in the effective implementation of the EU AI Act, regarding which the European Parliament and the Council reached a breakthrough legislative agreement on 9 December 2023. The Workplan also provides for the development of a comprehensive guidance on the use of large language models.
• AI tools and technology: the Workplan considers that Large Language Models, particularly chatbots, are likely to become a dominant tool in intellectual work as personal assistants. In this context, it stresses the need for any AI development to comply with data protection laws. The objective is to establish and provide frameworks across the European Medicines Regulatory Network (EMRN) to use AI tools to boost efficiency, deepen the understanding and analysis of data, and assist in decision-making processes. A Network Tools policy for open and collaborative AI development will be published by the end of 2024.
• Collaboration and training: the EMRN will continue collaborating internationally on AI with the International Coalition of Medicines Regulatory Authorities, EU entities, the medical devices sector, and academia. The European Specialised Expert Community of the EMA's Methodology Working Party will create a Special Interest Area on AI to facilitate a network for collaboration and knowledge sharing.
• Experimentation: the Workplan outlines a series of measures to establish a systematic method for conducting experimentation across the EMRN. Beginning at the end of 2024, technical deep dives that concentrate on particular tools and techniques, like digital twins, will be instrumental in guiding the experimentation process.

The HMA-EMA Big Data Steering Group will provide regular updates of the Workplan. Throughout its implementation, stakeholders and other interested parties will be kept informed and involved.