Industry is bringing artificial intelligence (AI) to EU medicines regulators faster than ever before, with the number of new AI applications discussed with applicants as part of regulatory procedures having risen sharply, according to a new report by the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA).
The 2025 AI Observatory Report, recently published by the HMA-EMA Network Data Steering Group (NDSG), provides a clear, system-wide view of ongoing AI initiatives and use in the development of medicines, in line with its 2026-2028 workplan. The NDSG aims to optimise how AI is used by the EU to support public and animal health in line with the European Medicines Agency Network Strategy (EMANS) to 2028. As part of its AI workstream, the Group monitors related activities to provide an overview of developments in the sector, from new AI applications to ongoing regulatory science research.
The report details the areas of collaboration seen in 2025, both at European and global levels, such as the development of the ten guiding principles of good AI practice in the medicines lifecycle by the EMA and the US Food and Drug Administration (FDA), released in January this year. Annex II of the report lists the types of AI applications discussed with applicants as part of regulatory procedures, noting many new applications by industry. While the majority of these focused on data handling and analysis, this extended over several areas of medicines development. Tools rolled out at both the national and network level are also detailed, such as the AI@MPA toolbox, and efforts by the NDSG to support the uptake of these tools into the network.
On the policy and guidance front, the report also notes the development of a coordinated roadmap for future AI-related guidance, as part of the aforementioned workplan. This roadmap will be aligned to the proposed Biotech Act, which is expected to be adopted later this year, and contains articles on AI in Chapter VI. Annex III details EU-funded initiatives exploring how AI is used in the development of medicines, with the report noting areas where future investment is required, such as AI tools for regulatory assessment, and also highlights an absence of initiatives in the veterinary medicines’ domain. In 2025, the NDSG also adopted the ‘Network AI research priorities’, which detailed seven domains where uncertainty remains and provided a guide to the areas for researchers and funding bodies to address, such as research integrity, data governance and bias prevention.
