The latest report on EMA’s stakeholder engagement activities for 2024–2025 highlights an intensification of dialogue and collaboration aimed at integrating external contributions into both the evaluation and safety monitoring of medicines. The Agency confirms a structured and increasingly inclusive approach, designed to ensure that multiple perspectives are reflected throughout regulatory processes.
At the core of this strategy is a multi-stakeholder model that continues to evolve into a dynamic platform for exchange. Within this framework, patient-centricity has consolidated its role as a guiding principle, consistently considered across all phases of a medicinal product’s lifecycle—from development to post-market surveillance.
Growing participation and structured collaboration
One of the most tangible signals of this strengthened engagement is the increase in participation within EMA’s key working groups. Representatives from patient and consumer associations involved in the Patients’ and Consumers’ Working Party rose from 22 to 25 member organisations, reflecting a broader inclusion of patient voices. A similar upward trend was observed in the Healthcare Professionals’ Working Party (HCPWP), confirming the Agency’s effort to expand the contribution of healthcare professionals in regulatory discussions.
Engagement also extended to the academic and research community. Independent and not-for-profit research was supported through dedicated dialogue channels such as Academia Briefing Meetings (ABMs) and Innovation Task Force (ITF) meetings. These initiatives were complemented by concrete support measures, including fee reductions for scientific advice, the qualification of novel methodologies, and procedural assistance—tools aimed at fostering innovation while maintaining regulatory rigor.
Industry engagement and regulatory alignment
Parallel to this, EMA maintained regular exchanges with industrial stakeholders. Interactions took place both within the Industry Standing Group (ISG) and through bilateral meetings with individual organisations. These discussions focused primarily on the implementation of new legislative requirements, as well as on assessing the broader impact of cross-sectoral regulations, an increasingly relevant aspect in a complex and interconnected regulatory landscape.
Overall, the report outlines a stakeholder engagement model that is becoming more structured, participatory and aligned with the evolving needs of the European healthcare ecosystem.