EMA Launches New Initiatives to Advance Women's Health Research

The European Medicines Agency (EMA) has launched a series of initiatives to strengthen the integration of women’s health considerations into medicines development and regulation. The measures aim to address long-standing gaps in research, diagnosis, and treatment that continue to affect women’s health outcomes despite women generally living longer than men. Through the initiative, EMA seeks to ensure medicines are developed, assessed, and regulated in ways that better reflect women’s specific healthcare needs.

Key Highlights:

• EMA launches new measures to improve women’s health research and regulation
• Agency to strengthen clinical trials, pregnancy research, and medicine labelling
• Women’s health workshop in September will shape future regulatory priorities

EMA Executive Director Emer Cooke described advancing women’s health as one of the agency’s key priorities. She noted that women spend a larger proportion of their lives in poor health due to persistent inequalities in disease prevention, diagnosis, and treatment. Cooke said the growing momentum across the European Union and internationally provides an opportunity for medicines regulators to support innovation and improve healthcare outcomes for women through more inclusive regulatory practices.

A key part of the initiative will be the Women’s Health Workshop scheduled for 28 and 29 September 2026. The event, which will be broadcast live, will bring together regulators, healthcare professionals, researchers, patients, industry representatives, and international organisations to review ongoing work, identify research gaps, and establish priorities for future medicines development. The workshop will also explore opportunities to strengthen collaboration and support more inclusive clinical research. Its findings will inform future regulatory actions and be published in a follow-up report.

EMA has identified four priority areas that will guide its work. The first focuses on improving women’s representation in clinical trials. Although current evidence indicates women are generally well represented in studies supporting the approval of new medicines in Europe, the agency will conduct more detailed analyses using data from the Clinical Trials Information System to ensure representation remains appropriate throughout every stage of clinical development.

The second priority aims to strengthen the assessment and labelling of medicines by ensuring sex-specific differences, including dosage requirements, treatment effectiveness, and safety profiles, are consistently evaluated and clearly reflected in product information. This approach is intended to provide healthcare professionals and patients with more accurate guidance on medicine use.

The third area addresses the use of medicines during pregnancy and breastfeeding, where important knowledge gaps remain. EMA plans to fund post-authorisation pregnancy studies, improve methods for detecting pregnancy-specific safety signals, strengthen pharmacovigilance practices, develop dedicated methodological guidance, and update medicine labelling to reflect the latest scientific evidence. The agency is also supporting the development of the ICH E21 guideline, which encourages the safe inclusion of pregnant and breastfeeding individuals in clinical trials.

The fourth priority focuses on expanding the use of real-world evidence through DARWIN EU®, which studies medicine use and disease patterns across different populations to provide insights beyond traditional clinical trials.

Looking ahead, EMA will encourage medicine developers to engage earlier with its scientific support programmes, reduce regulatory uncertainty, strengthen international collaboration, and identify research priorities that will help ensure future medicines better meet women’s healthcare needs.