'Now is really the time!' for women's health, says Cooke
EMA steps up efforts to improve medicines for women to address research gaps and accelerate innovation in women's health
The European Medicines Agency (EMA) is taking action to improve medicines for women. Despite living longer than men, women spend more years in poor health, with many conditions still underdiagnosed, under-researched or inadequately treated. EMA says it wants to change that.
“Advancing developments in women’s health is one of my personal priorities before I complete my mandate at EMA next year,” said EMA’s Executive Director Emer Cooke, at a round-table event co-hosted by the Gates Foundation and the Wellcome Trust. “I truly believe we can make a difference. There is currently great momentum on which we can capitalise, and we need both to showcase what the Agency has done and pave a path forward to enable future innovations.”
EMA is organising a workshop on 28-29 September that will bring together regulators, researchers, patients, healthcare professionals and industry to identify research priorities to map the biggest unmet needs.
The agency plans to strengthen women's representation in clinical trials, improve product labelling to reflect sex-specific differences, boost research on medicines during pregnancy and breastfeeding, and expand the use of real-world evidence through its DARWIN EU network.
EMA will also encourage developers to seek earlier scientific advice, deepen collaboration with international partners and identify areas where new medicines are most urgently needed.
The workshop's conclusions will shape future regulatory action, with a report outlining priorities and next steps to accelerate progress in women's health.
“Now is really the time!” said Cooke, pointing to the European Parliament Committee on Women's Rights and Gender Equality's report on inequalities between men and women in healthcare and the explicit inclusion of healthcare in the European Commission’s Gender Equality Strategy 2026-2030.
“There is currently great momentum on which we can capitalise, and we need both to showcase what the Agency has done and pave a path forward to enable future innovations.”