Women are missing from medicines development: EMA’s roadmap for change

30 Meán Fómhair 2026

10 priorities proposed to drive change in medicines for women’s health

By the end of 2026, EMA will develop a regulatory roadmap to help drive decisive change on how women’s health is considered across medicines development and regulation. This follows a multistakeholder workshop held on 28 and 29 September in Amsterdam where participants converged on a series of priority actions.

While women represent half of the world’s population, persistent gaps in research, evidence generation, and medicines development mean that many of their specific health needs remain insufficiently understood and addressed, contributing to poorer health outcomes and unmet medical needs. 

Women are still missing: from research and data, prevention, diagnosis and treatment. But the momentum to improve support for women’s health has never been stronger. Over the last two days, we have seen what can be achieved when diverse voices unite behind a common cause. Now is the time to act. EMA will build on this dialogue to shape a roadmap on medicines for women's health that will help drive progress, in Europe and beyond

EMA's Executive Director, Emer Cooke

Meaningful change starts with dialogue and with a shared understanding of the challenges we face. We end this workshop with a clear path to action”, “National regulatory authorities can drive progress across many areas. A key priority is to ensure that women are properly represented in clinical trials and that the data generated capture their experiences and needs, providing the evidence required for informed decisions and better care.

Director of the Spanish Agency for Medicines and Health Products (AEMPS) and Chair of the Heads of Medicines Agencies' (HMA) Management Group, María Lamas

The multistakeholder workshop, broadcast live, brought together over 100 leading voices on women’s health at EU and international level, from regulators to patients, healthcare professionals, non-governmental organisations (NGOs), industry and academia.

Over two days, the participants prioritised 10 proposed actions. These cover areas where EMA could lead, collaborate, or influence. The broad consensus among the diverse participants on the priority actions highlighted clear opportunities for change through greater global alignment.

The priority actions will feed into a roadmap on medicines for women’s health, which will include concrete deliverables with planned short-, medium- and long-term timelines. The roadmap, together with the workshop report, are planned for publication by the end of 2026.

10 actions for women’s health

1. Work together with patients and other stakeholders to identify priorities, evidence gaps and unmet needs.
2. Support research, including with adequate funding, to comprehensively address evidence gaps and unmet needs.
3. Improve enrolment of women in clinical trials and reporting of high-quality sex disaggregated data.
4. Support the inclusion of pregnant and breastfeeding individuals in clinical trials.
5. Ensure, early on and throughout medicines’ life cycle, that evidence is generated with women of all ages and stages of life in mind.
6. Support a sustainable infrastructure for the collection and analysis of real-world data. 
7. Train the European medicines regulatory network on sex- and gender sensitive assessment matters.
8. Improve the communication of benefits, risks and uncertainties related to medicines use in women.
9. Maintain structured collaboration and coordination across stakeholders and with international regulators.
10. Develop a framework of measurable outcomes and key performance indicators (KPIs) and regularly report on progress.