Although women generally live longer than men, they often face a greater burden of chronic illnesses and health limitations. Responding to this reality, the European Medicines Agency (EMA) has intensified its efforts to enhance the pharmaceutical care of women. Going forward, gender-specific differences in diseases and therapies will be more thoroughly incorporated into the development, assessment, and monitoring of medications.
Identifying Research Gaps
The initiative kicks off with a two-day workshop on September 28 and 29, involving representatives from regulatory authorities, academia, industry, healthcare professions, and patient organizations. This workshop will focus on identifying research gaps across the entire spectrum of women’s health. Additionally, priorities for a more robust evidence base and inclusive clinical research will be established.
According to the EMA, significant knowledge gaps still exist regarding gender-specific differences in disease progression and treatment effects. Conditions such as preeclampsia, endometriosis, and menopausal symptoms remain inadequately researched and are not sufficiently addressed in drug development.
Four Key Focus Areas of the EMA
Initially, the agency will concentrate on four central action areas. First, it will examine the representation of women in clinical trials more closely. While women are generally well-represented in regulatory studies for new medications in Europe, there is a need for a more detailed analysis of data from the Clinical Trials Information System (CTIS) to identify potential care gaps in specific developmental phases.
Secondly, the EMA aims to ensure that gender-specific differences in dosage, efficacy, and safety are consistently evaluated and included in product information and usage guidelines.
Enhancing Evidence for Pregnancy and Lactation
A special emphasis will be placed on the use of medications during pregnancy and breastfeeding. The EMA acknowledges that substantial knowledge gaps persist in this area. Consequently, the agency will promote post-approval studies, develop methods for better identification of pregnancy-specific safety risks, and devise new pharmacoepidemiological guidelines. Furthermore, product information will be updated to better reflect current knowledge.
Moreover, the EMA is contributing to the development of the international ICH Guideline E21, which aims to promote the safe inclusion of pregnant and breastfeeding women in clinical trials.
Utilizing Real-World Data
The fourth focus area concerns the use of real-world data. Through the European research network DARWIN EU®, the EMA is already investigating medicine applications and disease patterns across various population groups, including women. Initial studies are expected to be published in the summer, with additional analyses already planned.
Increased Support for Developers
In the future, the EMA also intends to reduce regulatory uncertainties and provide early guidance to new drug developers through scientific consultations and its Innovation Task Force. At the same time, international collaboration will be expanded to systematically identify research gaps and foster innovations in women’s health. The results of the workshop will be summarized in a report and serve as a foundation for further actions.
