# EMA women's health research initiative

> Live situation record from CLSTR: https://clstr.news/situations/ema-womens-health-research-initiative
> Updated: 2026-10-14T10:03:52.000Z. Sources: 8. Developments: 3.

The European Medicines Agency (EMA) is developing a regulatory roadmap to address critical gaps in medical research and drug development for women’s health. Following an expert workshop in Amsterdam in late September 2026 involving over 100 stakeholders, the agency intends to publish a strategy by the end of 2026 centered on ten priority actions.

Key objectives 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 aims to improve evidence regarding pregnancy and breastfeeding, utilizing the DARWIN EU network to study conditions like endometriosis and metabolic diseases affecting the 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 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.

## Timeline

### 2026-10-14: European health agencies move to prioritize women in medical research

The EMA and European Parliament are pushing for greater gender equality in healthcare, focusing on increasing women's participation in clinical trials and addressing systemic biases in medical research.

2 sources. https://clstr.news/cluster/european-health-agencies-move-to-prioritize-women-in-medical-research

### 2026-09-29: European Medicines Agency to launch roadmap for women's health research

The European Medicines Agency is developing a roadmap to address gender gaps in medical research, aiming to increase female participation in clinical trials and improve data on women's health.

4 sources. https://clstr.news/cluster/european-medicines-agency-to-launch-roadmap-for-womens-health-research

### 2026-09-14: EMA issues new guidelines for medicine shortage prevention

The EMA has introduced new guidelines requiring pharmaceutical companies to implement shortage prevention plans and is addressing high demand for scientific advice through potential procedural reforms.

2 sources. https://clstr.news/cluster/ema-issues-new-guidelines-for-medicine-shortage-prevention

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Cite as: EMA women's health research initiative. CLSTR, https://clstr.news/situations/ema-womens-health-research-initiative