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EMA steps up efforts on medicines for women’s health

Initiatives to map gaps, challenges and prioritise further actions
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EMA is launching initiatives to better embed women’s health considerations in medicines development and regulation. Women live longer than men on average but spend more of their lives in poorer health. This disparity is due to societal aspects as well as gaps in disease prevention, diagnosis, and treatments, which do not always fully address the specific health needs of women. 

Advancing developments in women’s health is one of my personal priorities. 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.

EMA’s Executive Director, Emer Cooke

EMA’s initiatives in this area will be discussed through a dedicated women’s health workshop on 28-29 September. The workshop, broadcast live, will take stock of current activities across the EU, including 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. It will explore further opportunities, drawing on input from patients, healthcare professionals, academia, industry and global partners. 

The current situation with regards to women’s health is influenced 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, menopausal symptoms, and endometriosis, remain insufficiently recognised or addressed.

EMA is already engaged in four main areas, with further activities planned, which will be also guided by the outcome of the workshop: 

  • Representation in clinical trials. The European Clinical Trials Regulation requires that the people enrolled in clinical trials reflect the populations likely to use a medicine. This means that if a disease is more common in women, then the clinical trials population needs to reflect this. So far, data shows that women are usually appropriately represented in trials used to support approval of new medicines in Europe. However, to better understand the situation at different stages of clinical development and ensure that women are appropriately represented, EMA will conduct more detailed analyses on the data held in the Clinical Trials Information System (CTIS).
  • Assessment and labelling of medicines. EMA will continue to make sure that potential sex-specific differences (e.g. differences in dosage requirements, efficacy and safety…) are assessed and appropriately reflected in the product labelling. 
  • The use of medicines in pregnancy and breastfeeding is an area where more information is needed; there are gaps in scientific knowledge and information to women on the benefits and risks of medicines. EMA has taken a leading role in this area and has been actively identifying opportunities for enhancing information on the benefits and risks of medicines in this population. Key actions include funding of post-authorisation studies of medicines in pregnancy, improving methods for the detection of pregnancy-specific safety signals, developing dedicated pregnancy pharmacoepidemiologic methodological guidance and strengthened pharmacovigilance practices with specific guidelines, and updating labelling requirements to better reflect available evidence. EMA has also taken a decisive role on the ongoing development of the ICH E21 guideline, which advocates for the safe inclusion of pregnant and breastfeeding individuals in clinical trials.
  • Real-world evidence studies provide information on how medicines perform in different populations (for example gender-related) or populations that were not studied in clinical trials. Through the Data Analysis and Real World Interrogation Network, DARWIN EU®, EMA conducts studies on medicine use and disease epidemiology related to women’s health. Some studies have now been completed and have been or will be published during the summer in the HMA-EMA Catalogue of RWD studies. Additional studies are planned.

Going forward, EMA will also focus on reducing regulatory uncertainty, by further encouraging developers to make full use of its early development support mechanisms (e.g. Innovation Task Force, academia briefing meetings, scientific advice) to tackle early on any methodological challenges linked to the development of new medicines related to women’s health. EMA will strengthen dialogue with its stakeholders and increase international collaboration with other regulators and organisations, around the topic of use of medicines in women. EMA also aims to help identify research gaps. The workshop on women’s health will map areas where medicines development is most needed. Its findings and follow-up actions will be summarised in a report published after the workshop. 

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