EMA Launches Comprehensive Initiative to Address Gender Gap in Medicines Development for Women's Health
核心洞察
The European Medicines Agency (搜索) is launching new initiatives to embed women's health considerations into medicines development and regulation across the EU.
A dedicated women's health workshop on September 28-29 will examine research gaps, identify priorities, and support more inclusive clinical research with input from patients, academia, and industry.
EMA is focusing on four key areas: representation in clinical trials, sex-specific assessment and labelling, medicines use during pregnancy and breastfeeding, and real-world evidence studies.
The European Medicines Agency (搜索) (EMA) is stepping up efforts to address long-standing gender disparities in pharmaceutical research and medicines regulation, launching a series of initiatives aimed at better embedding women's health considerations throughout the drug development lifecycle.
"This is an area where we are seeing strong momentum at EU and global level, and where EMA is well placed to drive meaningful progress and help shape a clear path ahead. As medicines regulators, we have a role to play to enable the development of products that are better tailored to women's needs," said EMA's Executive Director, Emer Cooke.
The current situation regarding women's health is shaped by a combination of factors, including the representation of women in clinical research, persistent gaps in understanding sex-based differences in disease and treatment effect, and the need to better integrate these differences in the development and use of medicines. As a result, some treatments do not fully meet women's specific needs, and certain conditions — such as preeclampsia (搜索), menopausal symptoms, and endometriosis (搜索) — remain insufficiently recognised or addressed.
Women's Health Workshop to Map Research Priorities
Central to EMA's renewed focus is a dedicated women's health workshop scheduled for September 28-29, which will be broadcast live. The workshop will take stock of current activities across the EU, including those from EMA, national regulators, and other organisations. It will examine research gaps across the full spectrum of women's health needs, identify priorities to strengthen the evidence base, and support more inclusive clinical research.
The event will draw on input from patients, healthcare professionals, academia, industry, and global partners. Findings and follow-up actions will be summarised in a report published after the workshop.
Four Pillars of EMA's Women's Health Strategy
EMA is already engaged in four main areas, with further activities planned and guided by the workshop's outcome.
In the area of representation in clinical trials, the European Clinical Trials Regulation requires that enrolled populations reflect those likely to use a medicine. Data so far shows that women are usually appropriately represented in trials supporting approval of new medicines in Europe. However, EMA will conduct more detailed analyses using data held in the Clinical Trials Information System (CTIS) to better understand the situation at different stages of clinical development.
For assessment and labelling of medicines, EMA will continue to ensure that potential sex-specific differences — including differences in dosage requirements, efficacy, and safety — are assessed and appropriately reflected in product labelling.
Regarding use of medicines in pregnancy and breastfeeding, EMA has taken a leading role in identifying opportunities for enhancing information on benefits and risks. Key actions include funding post-authorisation studies of medicines in pregnancy, improving methods for detecting pregnancy-specific safety signals, developing dedicated pregnancy pharmacoepidemiologic methodological guidance, strengthening pharmacovigilance practices with specific guidelines, and updating labelling requirements. EMA has also taken a decisive role in the ongoing development of the ICH E21 guideline, which advocates for the safe inclusion of pregnant and breastfeeding individuals in clinical trials.
Through real-world evidence studies, EMA's Data Analysis and Real World Interrogation Network (DARWIN EU) conducts studies on medicine use and disease epidemiology related to women's health. Some studies have been completed and will be published during the summer in the HMA-EMA Catalogue of RWD studies, with additional studies planned.
Reducing Regulatory Uncertainty and Fostering Collaboration
Going forward, EMA will focus on reducing regulatory uncertainty by encouraging developers to make full use of early development support mechanisms — including the Innovation Task Force, academia briefing meetings, and scientific advice — to tackle methodological challenges linked to developing new medicines for women's health early on. The agency also plans to strengthen dialogue with stakeholders and increase international collaboration with other regulators and organisations around the topic of medicines use in women.
Women live longer than men on average but spend more of their lives in poorer health, a disparity driven by societal aspects as well as gaps in disease prevention, diagnosis, and treatments that do not always fully address the specific health needs of women.