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[HEALTH] · EU · 2 sources

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European health agencies move to prioritize women in medical research

The European Medicines Agency (EMA) is shifting its approach to drug research to prioritize women's specific health needs. This initiative aims to address scientific data gaps and the insufficient representation of women in clinical trials. The agency seeks to increase female participation, improve gender-disaggregated data analysis, and expand research involving pregnant and breastfeeding women.

Data indicates significant underrepresentation; in the European Union, pregnant women participated in less than 0.4% of reported clinical trials, while breastfeeding individuals accounted for approximately 0.1%. The EMA is also working on international guidelines (ICH E21) to standardize research for these groups and intends to better utilize real-world medical data to monitor drug safety post-market.

In parallel, the European Parliament's Committee on Women's Rights and Gender Equality (FEMM) has issued a report calling for decisive action against systemic gender inequalities in healthcare. The report highlights that medical research, diagnostics, and treatments have historically focused on male physiology, leading to disparities in outcomes. For example, cardiovascular disease remains a leading cause of death in the EU, with higher mortality rates observed in women despite different symptomatic presentations compared to men.

Entities

Committee on Women's Rights and Gender Equality · European Medicines Agency · European Parliament