A new regulatory roadmap aimed at improving how women’s health is addressed in medicines development and regulation is expected to be published by the end of 2026. The initiative was announced by the European Medicines Agency (EMA) following a multi-stakeholder workshop held in Amsterdam on 28-29 September, which brought together more than 100 participants from across the healthcare ecosystem.
“Women are still missing: from research and data to prevention, diagnosis and treatment,” said EMA Executive Director Emer Cooke. “But the timing for improving support for women’s health has never been better. 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 for medicines addressing women’s health that will help drive progress in Europe and beyond.”
The proposed actions
The Amsterdam workshop identified ten priority actions across areas where EMA can lead, collaborate or influence the development of products for women’s health. While details will be outlined in the forthcoming roadmap, the broad priorities have already been defined. These include stronger engagement with patients and stakeholders to identify priorities, unmet needs and existing gaps, alongside enhanced support for research activities, including funding opportunities. Participants also highlighted the need to improve women’s recruitment into clinical trials, including pregnant and breastfeeding women, while ensuring the collection and reporting of high-quality sex-disaggregated data.
Another priority is to generate evidence throughout the entire lifecycle of medicines by ensuring the inclusion of women of all ages and life stages in research. Greater use of real-world data, supported by sustainable infrastructure, was also identified as a key enabler. At the regulatory level, the roadmap is expected to introduce training initiatives on sex- and gender-sensitive assessments across the European medicines regulatory network. It will also focus on improving communication of benefits, risks and uncertainties related to medicine use in women.
Finally, the roadmap is set to include measurable outcomes, key performance indicators (KPIs) and structured international collaboration to track progress and promote a more gender-responsive approach to medicines development and regulation.
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