Artificial Intelligence (AI) is fast evolving and is rapidly transforming the development and supervision of medicines.
The EU AI Act entered into force in 2024 and represents a significant step towards ensuring that AI is developed and used in a trustworthy, transparent and ethical way, while encouraging its uptake and creating a supportive environment for innovation. In 2025, it moved from adoption to practical application.
To keep abreast of such change and to support the development and evaluation of AI in the medicines’ lifecycle, every year the Network Data Steering Group (NDSG) monitors information on activities, trends and emerging AI domains and publishes the network ‘AI observatory’.
In line with the NDSG workplan, the 2025 AI Observatory report provides an overview of guidance and policy, applications of AI, ongoing collaborations and engagement activities with stakeholders and partners, as well as a high-level overview of progress in EU-funded initiatives and regulatory science research. It covers both the human and veterinary domains and does not attempt to be a
comprehensive and systematic review of all applications of AI.