Industry is bringing artificial intelligence to EU medicines regulators faster than ever before. The number of new AI applications discussed with applicants as part of regulatory procedures has risen sharply, reflecting how quickly the technology is being adopted across the development and evaluation of medicines.
In Europe, the Heads of Medicines Agencies-European Medicines Agency’s (HMA-EMA) Network Data Steering Group (NDSG) has published their 2025 AI Observatory Report, in line with their 2026-2028 workplan. One of the group’s aims serves to optimise how AI is utilised by the EU to support public and animal health in line with the European Medicines Agency Network Strategy (EMANS) to 2028. As part of their AI workstream, the group monitors related activities, which are summarised in the report to provide an overview of the developments in the sector, from new applications of AI to ongoing regulatory science research.
The report details the areas of collaboration seen in 2025, both at European and global level, such as the development of the ten guiding principles of good AI practice in medicines lifecycle by the EMA and the 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, in which the report notes many new applications by industry. Whilst the majority focussed on data handling and analysis, this extended over several areas of medicines development. Tools rolled at both the national and network level are also detailed, such as the AI@MPA toolbox, and efforts by the Network Data Steering Group (NDSG) to support the uptake of said 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 detailed the 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 highlighting an absence of initiatives in the veterinary medicines’ domain. 2025 also saw the NDSG adopt the ‘Network AI research priorities’, detailing seven domains where uncertainty remains and providing a guide to the areas for researchers and funding bodies to address, such as research integrity, data governance and bias prevention
