Peter Arlett, Head of Data Analytics at the European Commission

Developed under the HMA-EMA Big Data Steering Group, the workplan was designed to help the network use AI safely across medicines regulation while managing risks to human and animal health. Its vision extends beyond a single agency, promoting a coordinated European regulatory framework that uses AI for productivity, process automation, stronger data insights and better decision-making.

Over the past three years, the EMRN’s AI work has shifted from exploration to implementation. Early efforts focused on understanding how AI could support the medicines lifecycle and where regulatory risks might emerge. Since then, the network has built internal expertise, developed guiding principles for LLMs, created an AI Observatory for horizon scanning and translated this experience into practical guidance for regulators and industry.

This matters because the EMRN extends beyond the EMA, bringing together national competent authorities across the EEA with the EMA and HMA to regulate medicines. This coordinated approach helps create consistent expectations across Europe rather than fragmented interpretations between national regulators.

Stakeholder engagement has become a defining feature of the workplan. HMA and EMA’s multi-stakeholder AI workshop brought together regulators, patients, HCPs, academia and industry to discuss real use cases, regulatory expectations and the wider legal environment. The workshop concluded that the EMRN had already begun implementing its workplan across guidance, technology and policy.

International alignment is also strengthening. The EMA and FDA have published joint principles for Good AI Practice in drug development, signalling that European regulators are not developing expectations in isolation. For globally operating companies, this convergence will become increasingly important as AI becomes embedded in development, safety monitoring and regulatory operations.

Entering its fourth year, the EMRN’s AI workplan will continue to evolve. Europe’s medicines regulators are no longer focused solely on what AI might do, but on building the governance, guidance and collaborative structures needed to use it responsibly, creating clearer expectations and greater regulatory predictability.