EMA roadmap to improve women's inclusion in medicines development

Background

EMA committed to develop a regulatory roadmap by the end of 2026 to improve how women’s health is considered across medicines development and regulation, citing persistent gaps in research, evidence generation and clinical data that leave many women’s health needs insufficiently understood and addressed.

Workshop

The multistakeholder workshop on 28 and 29 September in Amsterdam brought together over 100 participants from regulators, patients, healthcare professionals, NGOs, industry and academia. Speakers highlighted that meaningful change requires dialogue, shared understanding and national regulatory action to ensure women are properly represented in clinical trials and that their experiences are captured.

Priority actions

Participants prioritised 10 actions for EMA to lead, collaborate on or influence: identify priorities and evidence gaps with patients and stakeholders; support research and funding; improve enrolment of women and sex‑disaggregated reporting; include pregnant and breastfeeding individuals in trials; generate lifecycle evidence for women of all ages; build sustainable real‑world data infrastructure; train regulators on sex‑ and gender‑sensitive assessment; improve communication of benefits, risks and uncertainties for women; maintain structured collaboration with stakeholders and international regulators; and develop measurable outcomes and KPIs.

Next steps

The prioritised actions will feed into the roadmap and a workshop report, both planned for publication by the end of 2026, with concrete deliverables and timelines for short-, medium- and long‑term implementation.