Historically, women have often been underrepresented in clinical research, resulting in important gaps in evidence on safety, efficacy and dose optimisation across different stages of life. While regulatory expectations have evolved considerably, challenges remain in generating robust data for pregnancy, breastfeeding, menopause and sex-specific differences in treatment response.
The European Medicines Agency (EMA) has now outlined a coordinated strategy to address these gaps. Key initiatives include improving the inclusion of women in clinical trials, strengthening evidence generation throughout the product lifecycle, enhancing information on medicine use during pregnancy and breastfeeding, and increasing the use of real-world evidence to support regulatory decision-making.
The latest Inside EMA podcast provides additional insight into these initiatives and discusses how regulators, academia, healthcare professionals and the pharmaceutical industry can work together to improve the evidence base for medicines used by women.
For regulatory professionals, these developments reinforce the growing importance of proactive evidence planning, inclusive clinical development programmes and lifecycle data generation. As regulatory expectations continue to evolve, integrating sex- and gender-specific considerations into development strategies will become increasingly important—not only to meet regulatory expectations, but ultimately to improve patient care.
