Summary
The European Medicines Agency plans to publish a roadmap by the end of 2026 to improve how women’s health is considered in medicines development and regulation. Ten proposed priorities include better clinical-trial representation, stronger evidence and clearer communication of benefits and risks.
The European Medicines Agency (EMA) plans to publish a regulatory roadmap by the end of 2026 to improve how women’s health is considered in medicines development and regulation. The plan follows a two-day multistakeholder workshop in Amsterdam on 28 and 29 September, where participants prioritised 10 proposed actions.
The EMA says gaps in research, evidence generation and medicines development leave some specific health needs insufficiently understood and addressed. The proposed actions range from improving trial participation and data collection to coordinating work among regulators and other stakeholders.
What the proposed priorities cover
More than 100 participants took part in the workshop, including regulators, patients, healthcare professionals, non-governmental organisations, industry and academia. The EMA said the actions identify areas where it could lead, collaborate or influence.
The priorities include:
- working with patients and other stakeholders to identify evidence gaps and unmet needs, and supporting research to address them;
- improving women’s enrolment in clinical trials and the reporting of high-quality data separated by sex;
- supporting the inclusion of pregnant and breastfeeding individuals in trials;
- generating evidence throughout a medicine’s life cycle with women of different ages and stages of life in mind;
- developing sustainable infrastructure for collecting and analysing real-world data;
- training the European medicines regulatory network in sex- and gender-sensitive assessment;
- improving communication about medicines’ benefits, risks and uncertainties for women;
- strengthening coordination among stakeholders and international regulators; and
- setting measurable outcomes and key performance indicators, with regular progress reports.
The EMA says the roadmap will turn these priorities into concrete deliverables with short-, medium- and long-term timelines. It and a report on the workshop are planned for publication by the end of 2026.
Why trial representation and data matter
A medicine’s evidence base depends on who participates in its studies and what information researchers collect. When women are under-represented, or results are not reported in a way that allows differences by sex to be examined, regulators and clinicians may have less evidence for assessing how well a medicine’s benefits and risks apply to women. Sex-disaggregated data means results are reported separately by sex; it is one of the tools proposed for making evidence more informative.
The workshop’s priorities also extend beyond trial enrolment. They call for evidence that accounts for different ages and life stages, including pregnancy and breastfeeding, and for better use of real-world data collected outside clinical trials. The proposals therefore cover both the generation of evidence and how it is assessed and communicated.
These are priorities for a future roadmap, rather than a set of new requirements already in force. The EMA’s next stated step is to define deliverables, timelines and ways to measure progress.