EMA Opens Its First Multistakeholder Workshop on Women's Health, Sets a Roadmap

The European Medicines Agency (EMA) convened its first dedicated multistakeholder workshop on women’s health on 28 and 29 September 2026 in Amsterdam. More than 100 participants—regulators, patients, healthcare professionals, NGOs, industry representatives and academics—gathered to examine persistent gaps in how women’s health is addressed in medicines development and regulation. The outcome is a set of ten prioritised actions that will form the basis of a regulatory roadmap on medicines for women’s health, scheduled for publication together with a workshop report by the end of 2026. EMA Executive Director Emer Cooke framed the event as the start of a clearer institutional answer to a long-standing question: what concrete steps will the agency take to ensure women are no longer missing from data, research, prevention, diagnostics and treatment.

Why the Workshop Matters Now

Women remain under-represented in many areas of clinical research and evidence generation. Conditions that predominantly affect women, such as endometriosis, preeclampsia and menopausal symptoms, have historically received less systematic attention in drug development. Sex-disaggregated data are often incomplete, and evidence on the use of medicines during pregnancy and breastfeeding remains limited. At European level, momentum has increased: the European Parliament’s FEMM Committee has highlighted women’s health, and healthcare appears explicitly as an action item in the European Commission’s Gender Equality Strategy 2026–2030. The EMA workshop was designed to convert that momentum into practical regulatory priorities.

Structure and Participants

The hybrid meeting, chaired by Emer Cooke and Maria Lamas (Heads of Medicines Agencies / AEMPS), brought together the European Medicines Regulatory Network and external stakeholders. Sessions mapped existing contributions from regulators, reviewed epidemiological and clinical evidence gaps, and explored opportunities for more inclusive trial design and real-world data generation. Live broadcast ensured wider accessibility. The diversity of voices—patients and clinicians alongside industry and academia—was intended to produce shared ownership of the resulting priorities rather than a purely regulator-driven list.

Ten Priority Actions

Participants converged on ten proposed actions covering areas where EMA can lead, collaborate or influence. These include identifying evidence gaps together with patients and stakeholders; supporting research and funding; improving enrolment of women and sex-disaggregated reporting; facilitating the inclusion of pregnant and breastfeeding individuals in trials where appropriate; generating lifecycle evidence for women of all ages; building sustainable real-world data infrastructure; training regulators on sex- and gender-sensitive assessment; improving communication of benefits, risks and uncertainties specific to women; maintaining structured collaboration with stakeholders and international regulators; and developing measurable outcomes and key performance indicators. The breadth of the list reflects consensus that progress requires simultaneous work on research design, data systems, regulatory science and communication.

From Workshop to Roadmap

The prioritised actions will be translated into a formal regulatory roadmap containing concrete deliverables with short-, medium- and long-term timelines. A public workshop report summarising findings, lessons learned and proposed next steps will accompany the roadmap. Both documents are planned for release by the end of 2026. The roadmap is expected to guide EMA’s own work programme and to provide a reference point for national competent authorities, industry and research funders.

Implications for Medicines Development

For pharmaceutical and biotech companies, the emerging roadmap signals that sex- and gender-sensitive evidence generation will receive greater regulatory attention. Trial protocols that systematically under-enrol women or omit sex-disaggregated analysis may face sharper scrutiny. Developers working on conditions that primarily affect women, or on products used across the female life course, can expect clearer expectations around evidence packages. At the same time, improved guidance and data infrastructure could reduce uncertainty for sponsors willing to generate more inclusive evidence.

Broader Regulatory and Policy Context

The workshop sits within EMA’s existing workstreams on women’s health, including efforts to strengthen evidence on medicines in pregnancy and breastfeeding and to leverage real-world data platforms such as DARWIN EU. It also aligns with wider European policy emphasis on gender equality in health. Because medicines development is global, advances in European regulatory practice are expected to influence—and be influenced by—international discussions on sex and gender in clinical research.

Outlook

EMA’s first multistakeholder workshop on women’s health has produced a focused list of ten priority actions and a clear commitment to publish a regulatory roadmap by the end of 2026. The test will be whether those actions translate into measurable changes in trial design, data standards, regulatory assessment and ultimately in the availability of better-evidenced treatments for women. For industry, researchers and patient organisations, the roadmap will provide a concrete framework against which progress can be tracked. For the agency itself, the workshop marks a public pivot from acknowledging long-standing gaps to setting timed, accountable steps toward closing them.

Sources

• https://www.ema.europa.eu/en/news/women-are-missing-medicines-development-emas-roadmap-change

• https://www.ema.europa.eu/en/news/executive-director-speech-ema-womens-health-multi-stakeholder-workshop

• https://chemxplore.com/news/ema-roadmap-womens-health-medicines

• https://www.ema.europa.eu/en/events/multistakeholder-workshop-womens-health

• https://www.ema.europa.eu/en/news/ema-steps-efforts-medicines-womens-health