On 18 December 2023, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMAs) of the Member States published a five-year "Workplan" on Artificial Intelligence (AI), aimed at defining a strategy to maximise the benefits of AI for stakeholders while managing its risks.
Responding to the rapid advancement of AI in the life sciences sector, the Workplan focuses on four key areas in order to promote the development and use of what is defined as 'responsible and beneficial AI'.
- Guidelines, policies and product support: the Workplan outlines a commitment to provide ongoing support for products under development and includes the definition and evaluation of appropriate AI guidelines for the entire life cycle of pharmaceutical products. Furthermore, starting in the year just begun, various initiatives will be launched to facilitate the effective implementation of the AI ACT, on which the European Parliament and the Council reached a groundbreaking legislative agreement on 8 December 2023.
- AI tools and technologies: the Workplan considers that Large Language Models, especially chatbots, are likely to become a dominant tool in intellectual work as personal assistants. In this context, it will be necessary for any AI development to comply with data protection laws. The aim is to establish and provide a framework throughout the European Medicines Regulatory Network (EMRN) for the use of AI tools to increase efficiency, deepen understanding and analysis of data, and assist decision-making processes.
- Collaboration and education: the EMRN will continue to collaborate internationally on AI with the International Coalition of Medicines Regulatory Authorities, various EU bodies, the medical device industry and academia. The European community of specialised experts of the EMA methodology working group will create a special area of interest on AI to facilitate a network of collaboration and knowledge sharing.
- Experimentation: the Workplan outlines a series of measures to establish a systematic method for conducting experimentation throughout the EMRN. From the end of 2024, insights that focus on particular tools and techniques, such as Digital Twins, will be key to guiding the experimentation process.