The European Medicines Agency (EMA) has launched a strategic initiative to strengthen women’s health in medicines development through improved clinical trial representation, pregnancy safety research, real-world evidence, and regulatory guidance, with new priorities to be shaped at a September 2026 stakeholder workshop.
Written By: Fariha Sameen, PharmD
Reviewed By: Pharmacally Editorial Team
The European Medicines Agency (EMA) has launched a strategic initiative to better integrate women’s health into medicines development and regulation, aiming to close scientific and clinical evidence gaps that continue to affect healthcare outcomes across Europe. The initiative spans clinical research, medicine assessment, pregnancy safety, and real-world evidence generation, and will culminate in a dedicated Women’s Health Workshop on September 28-29 to define future priorities.
EMA said the initiative reflects growing recognition that although women generally live longer than men, they spend a greater proportion of their lives in poorer health. The disparity is driven by a combination of societal factors and persistent gaps in disease prevention, diagnosis, clinical research, and treatment development.
Why Women’s Health Requires Greater Regulatory Attention
The agency said important sex-based differences in disease biology and treatment response are not always fully reflected during medicines development or regulatory evaluation. As a result, some therapies may not adequately address women’s specific healthcare needs.
EMA also highlighted persistent research gaps affecting conditions such as endometriosis, preeclampsia, and menopausal symptoms, which continue to be under-recognized despite their substantial impact on women’s health.
Emer Cooke: Regulators Have a Key Role
EMA Executive Director Emer Cooke described advancing women’s health as one of the agency’s strategic priorities.
Cooke said strong momentum is building across Europe and globally to improve women’s health, adding that medicines regulators have an important responsibility to support the development of therapies that better address women’s healthcare needs while enabling more inclusive and scientifically robust evidence generation.
Clinical Trial Representation Under Review
One of EMA’s priorities is ensuring women are appropriately represented throughout clinical development.
Under the European Clinical Trials Regulation, clinical trial populations should reflect the patients expected to receive a medicine once approved. Current evidence indicates that women are generally well represented in studies supporting marketing authorisations in Europe.
To better understand participation across different stages of development, EMA will conduct more detailed analyses using data from the Clinical Trials Information System (CTIS). The findings will help identify whether additional measures are needed to improve representation where evidence gaps remain.
Strengthening Assessment of Sex-Specific Differences
EMA will continue evaluating whether biological sex influences medicine efficacy, safety, pharmacology, or dosage requirements during regulatory assessment.
Where clinically meaningful differences are identified, the agency will ensure these findings are accurately reflected in product information and prescribing guidance to support evidence-based treatment decisions.
Improving Evidence for Pregnancy and Breastfeeding
The use of medicines during pregnancy and breastfeeding remains one of the largest evidence gaps in clinical medicine.
EMA is addressing this through coordinated regulatory actions, including funding post-authorisation pregnancy studies, improving methods to detect pregnancy-specific safety signals, strengthening pharmacovigilance guidance, updating product labeling to better reflect available evidence, and contributing to development of the ICH E21 guideline, which supports the safe inclusion of pregnant and breastfeeding individuals in clinical research.
Expanding the Role of Real-World Evidence
EMA is also strengthening the use of real-world evidence through its Data Analysis and Real-World Interrogation Network (DARWIN EU®).
The network is conducting studies on medicine use and disease epidemiology in women, helping regulators understand how medicines perform in routine clinical practice and in patient groups that may be underrepresented in clinical trials. Several studies have been completed, with additional analyses expected to be published through the HMA-EMA Catalogue of Real-World Data Studies during the summer.
September Workshop Will Shape Future Priorities
The Women’s Health Workshop on September 28-29 will bring together regulators, healthcare professionals, researchers, patient representatives, academia, industry, and international partners to review ongoing activities across Europe and identify remaining scientific and regulatory challenges.
Discussions will focus on research gaps throughout the women’s health landscape, opportunities to strengthen inclusive clinical research, and strategies to improve the evidence base supporting medicines used by women.
Path Forward
Beyond the workshop, EMA plans to reduce regulatory uncertainty by encouraging medicine developers to engage earlier through scientific advice, Innovation Task Force consultations, and dedicated support for academic researchers. The agency also intends to strengthen international collaboration and help identify priority areas where medicines development remains limited.
EMA will publish a report following the workshop summarizing the discussions, key findings, and planned follow-up actions, providing a roadmap for advancing women’s health considerations throughout medicines development and regulatory decision-making across the European Union.
References
EMA steps up efforts on medicines for women’s health | European Medicines Agency (EMA)
About the Writer
Fariha Sameen, PharmD (LinkedIn), is a clinical pharmacy professional with hands-on experience in patient counselling, medication review, therapeutic monitoring, and clinical documentation across multiple departments. She has experience identifying and assessing drug-related problems and supporting medication safety practices. Her interests include pharmacovigilance, ADR reporting, clinical research, and medical writing focused on clear, evidence-based communication.