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EMA Enhances Focus on Women’s Health in Medicines Development
Developing
In Short: The European Medicines Agency (EMA) has launched initiatives to better integrate women’s health considerations in medicines development and regulation, making clinical trial data publicly available and planning more detailed analyses.
The European Medicines Agency (EMA) has stepped up its efforts to better embed women’s health considerations in medicines development and regulation. As part of these initiatives, the agency has made publicly available information on the representation of women and men in clinical trials authorised under the Clinical Trials Regulation since January 2022, which is detailed in the quarterly monitoring reports on the European clinical trials environment published on the ACT EU website.
The Clinical Trials Information System (CTIS), the EU's central database for clinical trials established under the Clinical Trials Regulation, will further enable EMA to conduct more detailed analyses of representation across different stages of clinical development and across population groups, including women, as well as across life stages, age groups, and ethnicities.
By enhancing transparency and providing more comprehensive data, the EMA aims to ensure that medicines are developed with a better understanding of how they affect women, ultimately improving health outcomes for this demographic.
This move by the EMA aligns with its broader mission to evaluate and supervise pharmaceutical products, reflecting the agency's commitment to advancing public health through more inclusive and representative research.
Background
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products (EAEMP) or European Medicines Evaluation Agency (EMEA).
What's confirmed
What's still developing
- EMA has launched various initiatives to better embed women’s health considerations in medicines development and regulation.
- Information on the representation of women and men in clinical trials authorised under the Clinical Trials Regulation since January 2022 is publicly available in the quarterly monitoring reports on the European…
- It shows whether trials involve women, men or both: The Clinical Trials Information System (CTIS), the EU's central database for clinical trials established under the Clinical Trials Regulation, will also enable EMA…