EMA executive director Emer Cooke used the end of her six-year mandate to reiterate concern that women remain under-represented in clinical research. Cooke said the continued imbalance produces inequity in areas of women’s health, pointing to lingering gaps in how treatments are understood across sex-based differences. Her remarks reflect a governance and design issue rather than a single drug decision: trial enrollment practices and subgroup reporting standards remain central to how well regulators can assess benefits and risks across populations. The statement also serves as an external signal to sponsors planning global programs, where demographic recruitment and statistical considerations will increasingly influence study planning. For biotech, the takeaway is that trial design quality increasingly includes representativeness and sex-based analysis plans, not only endpoints and primary efficacy structure.