EMA opens first women's health multistakeholder workshop

Purpose

The Executive Director opened EMA’s first women’s health multistakeholder workshop, highlighting persistent gaps in data, research, prevention and diagnostics that leave women under‑represented in clinical research and with poorer health outcomes despite longer lifespans.

EMA actions

EMA said it is monitoring clinical trial representation, issuing targeted guidance, requiring tailored dosages and warnings when necessary, and stepping up work on the safe use of medicines during pregnancy and lactation. The agency is also using real‑world data to understand medicine use and disease patterns in women and strengthening international collaboration.

Workshop goals

The event gathers experts, patients, healthcare professionals, regulators and industry to take stock of gaps and explore actions to speed innovation for women. The intended output is a roadmap of practical, measurable actions and a public report summarising key findings, lessons learned and proposed next steps.

Policy context and rationale

The speech referenced growing political momentum, including the European Commission’s Gender Equality Strategy 2026–2030 and the EU Safe Hearts Plan’s focus on sex‑specific risks and early detection. Better diagnosis and treatments for women were framed as both health imperatives and economic priorities, reducing infertility complications and pressure on healthcare systems.

Commitment

The Executive Director said improving women’s health is a personal and organisational priority to be advanced before the end of her mandate and called for joint action across regulators, clinicians, researchers, patients and industry.