European Medicines Agency to launch roadmap for women's health research

The European Medicines Agency (EMA) has announced the development of a regulatory roadmap to address significant gaps in medical research and drug development concerning women's health. This initiative follows a workshop held in Amsterdam in late September 2026, which brought together over 100 experts from regulatory authorities, the pharmaceutical industry, academia, and patient advocacy groups.

EMA Executive Director Emer Cooke highlighted that women remain “invisible” in much of the data, prevention, diagnosis, and treatment processes. The upcoming roadmap, expected to be published by the end of 2026, will focus on ten priority actions. Key objectives include increasing female participation in clinical trials and ensuring the availability of high-quality, sex-disaggregated data to better understand how medications affect different populations.

The strategy also aims to improve evidence regarding women during pregnancy and breastfeeding, areas where current data is notably scarce. Additionally, the agency plans to leverage “real-world” data through the DARWIN EU network to conduct specific studies on conditions such as endometriosis and metabolic diseases affecting the ovaries.