女性在药物开发中缺位：欧洲药品管理局（EMA）的变革路线图
正文 · 中文译文
到2026年底，EMA将制定一份监管路线图，以帮助推动在药物开发和监管中如何考虑女性健康方面发生决定性变革。此前，9月28日至29日在阿姆斯特丹举行了一次多方利益相关者研讨会，与会者就一系列优先行动达成了共识。 尽管女性占世界人口的一半，但研究、证据生成和药物开发方面持续存在的差距意味着，她们的许多特定健康需求仍未得到充分理解和解决，导致较差的健康结果和未满足的医疗需求。 女性仍然缺失：从研究和数据、预防、诊断和治疗中。但改善女性健康支持的势头从未如此强劲。在过去两天里，我们看到了当不同的声音为了共同的事业而团结起来时可以实现什么。现在是采取行动的时候了。EMA将在此次对话的基础上，制定一份关于女性健康药物的路线图，以帮助推动欧洲及其他地区的进步。 有意义的改变始于对话和对我们所面临挑战的共同理解。我们带着一条明确的行动路径结束本次研讨会”，“国家监管机构可以在许多领域推动进步。一个关键优先事项是确保女性在临床试验中得到充分代表，并确保生成的数据反映她们的经历和需求，为知情决策和更好的护理提供所需证据。 多利益相关方研讨会以直播形式举行，汇集了100多位欧盟和国际层面女性健康领域的权威声音，包括监管机构、患者、医疗保健专业人员、非政府组织（NGO）、行业和学术界。 在两天的时间里，参与者确定了10项拟议行动的优先顺序。这些行动涵盖欧洲药品管理局（EMA）可以牵头、合作或影响的领域。不同参与者对优先行动形成的广泛共识，凸显了通过加强全球协调实现变革的明确机会。 优先行动将纳入一份女性健康药物路线图，该路线图将包含具有计划短期、中期和长期时间表的具体交付成果。路线图连同研讨会报告计划于2026年底前发布。 与患者及其他利益相关方合作，确定优先事项、证据缺口和未满足的需求。 支持研究（包括提供充足资金），以全面解决证据缺口和未满足的需求。 提高女性在临床试验中的入组率，并报告高质量按性别分类的数据。 支持将孕妇和哺乳期个体纳入临床试验。 确保在药物生命周期的早期及整个过程中，都考虑到所有年龄和生命阶段的女性来生成证据。 支持建立可持续的基础设施，用于收集和分析真实世界数据。 对欧洲药品监管网络进行生理性别和社会性别敏感性评估事项方面的培训。 改善与女性用药相关的获益、风险和不确定性的沟通。 维持各利益相关方之间以及与国际监管机构之间的结构化协作与协调。 制定可衡量结局和关键绩效指标（KPI）的框架，并定期报告进展。 关于女性健康的多利益相关方研讨会（2026年9月28日至29日） 电话：+31 (0)88 781 8427 电子邮箱：press@ema.europa.eu
正文 · 英文原文
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. Women are still missing: from research and data, prevention, diagnosis and treatment. But the momentum to improve support for women’s health has never been stronger. Over the last two days, we have seen what can be achieved when diverse voices unite behind a common cause. Now is the time to act. EMA will build on this dialogue to shape a roadmap on medicines for women's health that will help drive progress, in Europe and beyond Meaningful change starts with dialogue and with a shared understanding of the challenges we face. We end this workshop with a clear path to action”, “National regulatory authorities can drive progress across many areas. A key priority is to ensure that women are properly represented in clinical trials and that the data generated capture their experiences and needs, providing the evidence required for informed decisions and better care. 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. Work together with patients and other stakeholders to identify priorities, evidence gaps and unmet needs. Support research, including with adequate funding, to comprehensively address evidence gaps and unmet needs. Improve enrolment of women in clinical trials and reporting of high-quality sex disaggregated data. Support the inclusion of pregnant and breastfeeding individuals in clinical trials. Ensure, early on and throughout medicines’ life cycle, that evidence is generated with women of all ages and stages of life in mind. Support a sustainable infrastructure for the collection and analysis of real-world data. Train the European medicines regulatory network on sex- and gender sensitive assessment matters. Improve the communication of benefits, risks and uncertainties related to medicines use in women. Maintain structured collaboration and coordination across stakeholders and with international regulators. Develop a framework of measurable outcomes and key performance indicators (KPIs) and regularly report on progress. Multistakeholder workshop on women’s health (28-29/09/2026) Tel. +31 (0)88 781 8427 E-mail: press@ema.europa.eu