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EMA - European Medicines Agency · EU-wide · 30 Mar 2023 · News & press

Women are missing from medicines development: EMA's roadmap for change

Original title: Women are missing from medicines development: EMA’s roadmap for change

AI-generated summary

The European Medicines Agency will develop a regulatory roadmap by end of 2026 to address gaps in women's health medicines development and regulation. Following a September multistakeholder workshop in Amsterdam with over 100 participants from regulators, patients, healthcare professionals, industry and academia, 10 priority actions were identified covering areas where EMA could lead, collaborate or influence. The roadmap will include concrete deliverables with short-, medium- and long-term timelines and will be published alongside a workshop report by end of 2026.

Dates and deadlines
Regulatory deadline
31 Dec 2026
From EMA - European Medicines Agency

Image credit: © Sabrina | stock.adobe.com

Women are missing from medicines development: EMA’s roadmap for change

10 priorities proposed to drive change in medicines for women’s health

By the end of 2026, EMA will develop a regulatory roadmap to help drive decisive change on how women’s health is considered across medicines development and regulation. This follows a multistakeholder workshop held on 28 and 29 September in Amsterdam where participants converged on a series of priority actions.

While women represent half of the world’s population, persistent gaps in research, evidence generation, and medicines development mean that many of their specific health needs remain insufficiently understood and addressed, contributing to poorer health outcomes and unmet medical needs.

The multistakeholder workshop, broadcast live, brought together over 100 leading voices on women’s health at EU and international level, from regulators to patients, healthcare professionals, non-governmental organisations (NGOs), industry and academia.

Over two days, the participants prioritised 10 proposed actions. These cover areas where EMA could lead, collaborate, or influence. The broad consensus among the diverse participants on the priority actions highlighted clear opportunities for change through greater global alignment.

The priority actions will feed into a roadmap on medicines for women’s health, which will include concrete deliverables with planned short-, medium- and long-term timelines. The roadmap, together with the workshop report, are planned for publication by the end of 2026.

Excerpt from the official page. The original is authoritative.