Summary
At EMA’s first multi-stakeholder workshop on women’s health, Executive Director Emer Cooke called for a practical, measurable roadmap to address gaps in research, diagnosis and treatment. The agency plans to publish a report of the workshop’s findings and proposed next steps.
The European Medicines Agency (EMA) wants its first multi-stakeholder workshop on women’s health to lead to a practical, measurable action roadmap. In remarks in Amsterdam on 28 September 2026, Executive Director Emer Cooke said the agency would work with researchers, patients, healthcare professionals, regulators and industry to address gaps in women’s health research and care.
Cooke described the workshop as a chance to take stock of those gaps, identify challenges and consider steps to speed progress. EMA said it would publish a report summarising the workshop’s findings, lessons and proposed next steps for women’s health in the European Union. The roadmap was presented as an intended outcome of the work, not as a completed plan.
Why EMA is calling for action
Cooke said women have historically been underrepresented in clinical research and that gaps remain in understanding sex-based differences in health. She also pointed to conditions affecting many women that can be under-recognised, and said research advances do not always lead to the investment and innovation needed to improve care.
The agency’s stated aim is to help innovative medicines reach women faster, alongside better research, diagnosis and treatment options. Cooke linked the issue to differences in health outcomes and to whether treatments adequately reflect women’s needs.
She also described a wider European policy context. Cooke said healthcare had been included as an action item in the European Commission’s Gender Equality Strategy 2026–2030, and highlighted the EU Safe Hearts Plan’s focus on sex-specific cardiovascular risks, early detection in women and inequalities in cardiovascular care.
EMA’s current areas of work
Cooke said EMA is monitoring representation in clinical trials and issuing targeted guidance. She added that the agency is requiring tailored dosages and warnings where necessary, and increasing its work on the safe use of medicines during pregnancy and lactation.
Other areas she identified include using real-world data to better understand medicine use and disease patterns in women, strengthening dialogue with stakeholders and expanding international collaboration. These activities formed part of the background to the workshop; the speech did not specify a timetable or set out the proposed roadmap’s individual measures.
The planned public report is the next stated step for turning the workshop’s discussions into proposed actions.