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EMA has launched various initiatives to better embed women’s health considerations in medicines development and regulation.
These efforts address ongoing challenges, including gaps in understanding how diseases and medicines affect women and men differently, and the need for better treatments for conditions that primarily affect women.
EMA is also strengthening collaboration with a wide range of stakeholders to identify research gaps and support innovation to address unmet needs in women's health.
These stakeholders include EU regulators, patients, healthcare professionals, academia, the pharmaceutical industry and global partners.
In the EU, the Clinical Trials Regulation requires that the participants enrolled in clinical trials reflect the populations likely to use a medicine. This means that if a disease is more common in women, the trial population needs to reflect this.
EMA monitors participation in clinical trials across different population groups, including women.
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 clinical trials environment published on the ACT EU website. 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 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.
This work supports the objectives of the Accelerating Clinical Trials in the EU (ACT EU) initiative, as set out in its 2026-2027 workplan, which aims to strengthen clinical research by improving the inclusion of underrepresented populations, including women, pregnant and breastfeeding individuals.
For more information, see:
Related publication:
EMA encourages developers of medicines addressing women's health needs to make full use of the Agency's early development support tools.
These can help address methodological challenges related to women's health early in the development process.
These tools include:
For more information, see:
Scientific guidelines are available to support the development of medicines in the areas relevant to women’s health, including recommendations on the design and conduct of clinical trials.
These guidelines include:
Guidance is also available on the impact of sex differences in cardiovascular disease:
EU regulators assess differences between women and men in the efficacy, safety and use of medicines before a medicine is authorised, where relevant.
Where these differences have implications for how a medicine is used, they are reflected in the product information.
After a medicine is authorised, companies must continue to monitor and report its safety and efficacy, including data broken down by sex where relevant and available.
They should include any important new findings from company-sponsored clinical trials, published scientific literature and relevant spontaneous adverse reaction reports in periodic safety update reports.
EMA's Pharmacovigilance Risk Assessment Committee (PRAC) assesses these reports. Where necessary, it recommends changes to the product information or other regulatory actions.
EMA is responsible for medicines authorised through the EU's centralised procedure. Many medicines used in women's healthcare in the EU are authorised nationally.
For more information, see:
EMA is playing a leading role in improving knowledge on the use of medicines during pregnancy and breastfeeding.
The Agency identifies data gaps and works to strengthen evidence on medicine safety.
It collaborates with regulatory partners and stakeholders globally, including through the development of the ICH E21 guideline, which supports the inclusion of pregnant and breastfeeding individuals in clinical trials.
The aim is to help healthcare professionals and patients make informed treatment decisions during pregnancy and breastfeeding.
For more information, see:
Through DARWIN EU® (Data Analysis and Real World Interrogation Network), EMA commissions studies on disease patterns, disease burden and medicine use in women.
These studies generate real world evidence to improve understanding of women's health and how medicines are used and perform in different populations, particularly where limited information is available from clinical trials.
Areas of research include:
Information on individual studies is available in the HMA-EMA catalogues of real world data studies. Click on the expandable panel below to find the links to these studies.
Information on the real world evidence studies on pregnancy and breastfeeding is available via the link below:
For more information on DARWIN EU, see:
EMA is organising a dedicated women’s health workshop on 28–29 September 2026.
The workshop aims to review ongoing activities, identify research gaps and priorities, and explore opportunities to strengthen the evidence base and support more inclusive clinical research.
It will bring together a wide range of stakeholders, including:
More information is available on the event page:
An update log is available to show the date and summary of changes to this webpage. It does not include updates to linked documents or minor edits like typos or broken link fixes.
The tracking of updates begins in September 2026.
2 September 2026
Page first published