EMA Launches Women's Health Initiative Targeting Clinical Trial Design and Labelling Requirements

Regulatory affairs and R&D teams operating under EMA oversight face a structured reassessment of how sex-specific differences are handled across clinical development and product labelling, as the agency formalises a multi-workstream initiative on women's health ahead of a 28–29 September workshop.

The initiative addresses a documented gap: women are underrepresented in certain stages of clinical development, and conditions including preeclampsia, menopausal symptoms, and endometriosis remain insufficiently characterised in the evidence base. EMA has identified four active workstreams, clinical trial representation, assessment and labelling, real-world evidence, and pregnancy and breastfeeding pharmacovigilance, with further priorities to be shaped by the September workshop's outputs.

On trial representation, EMA will conduct granular analyses of enrollment data held in the Clinical Trials Information System (CTIS), moving beyond aggregate approval-stage figures to examine sex-disaggregated data across earlier development phases. The European Clinical Trials Regulation already requires that enrolled populations reflect likely real-world users; the forthcoming analyses will test whether that requirement is being met consistently across the development continuum.

For labelling, EMA will strengthen requirements to ensure sex-specific differences in dosage, efficacy, and safety are reflected in approved product information. Pregnancy and breastfeeding represent the most acute gap: EMA is funding post-authorisation studies, developing pregnancy-specific pharmacoepidemiologic methodology, and refining pharmacovigilance signal detection for this population. The agency has also taken an active role in developing ICH E21, the guideline advocating for the safe inclusion of pregnant and breastfeeding individuals in clinical trials.

Real-world evidence is a parallel track. Through DARWIN EU, EMA is running studies on medicine use and disease epidemiology in women, with completed studies scheduled for publication in the HMA-EMA Catalogue of RWD Studies during summer 2026. Additional studies are planned, with scope to be refined post-workshop.

The September workshop, broadcast live, will draw on input from national regulators, patients, healthcare professionals, academia, industry, and global partners, positioning its outputs as a direct input into EMA's regulatory planning cycle rather than a standalone consultation exercise.

Regulatory affairs leads should track the CTIS analysis methodology and any draft updates to labelling guidance that emerge from the workshop, as both carry direct implications for dossier preparation and post-authorisation commitments.

Source: European Medicines Agency via ema.europa.eu, 2 July 2026. Workshop scheduled 28–29 September; broadcast live.