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EMA women's health research initiative

Updated 1 time since CLSTR started tracking revisions of this situation.

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2026-09-30 20:12 UTC → 2026-10-15 05:45 UTC · added removed

The European Medicines Agency (EMA) has announced plans to develop is developing a regulatory roadmap aimed at addressing to address critical gaps in medical research and drug development gaps in for women’s health. Following an expert workshop in Amsterdam, Amsterdam in late September 2026 involving over 100 stakeholders, the agency intends to publish a strategy by the end of 2026 focusing centered on ten priority actions. Key objectives of the roadmap include increasing female participation in clinical trials and ensuring the availability of high-quality, sex-disaggregated data. EMA Executive Director Emer Cooke noted that women remain “invisible” in many aspects of medical data, prevention, diagnosis, and treatment. The initiative will also seek aims to improve evidence regarding pregnancy and breastfeeding, while utilizing the DARWIN EU network to study conditions such as like endometriosis and metabolic diseases affecting the ovaries ovaries. Recent data highlights the scale of underrepresentation in the European Union, where pregnant women participated in less than 0.4% of reported clinical trials and endometriosis. breastfeeding individuals accounted for approximately 0.1%. To address this, the EMA is working on international guidelines (ICH E21) to standardize research for these groups and improve post-market drug safety monitoring through real-world data. In support of these efforts, the European Parliament’s Committee on Women’s Rights and Gender Equality (FEMM) issued a report calling for action against systemic gender inequalities in healthcare. The report notes that historical focus on male physiology has led to disparities in outcomes, such as higher mortality rates for women from cardiovascular disease due to differing symptomatic presentations.

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  1. 2026-10-15 05:45 UTC EMA women's health research initiative
  2. 2026-09-30 20:12 UTC EMA women's health research initiative

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