欧洲药品管理局（EMA）紧急任务小组（ETF）与非洲药品管理局（AMA）发布了一份联合立场文件，以支持潜在……的临床试验及时启动
EMA’s Emergency Task Force (ETF) and the African Medicines Agency (AMA) have published a joint position paper to support the timely start of clinical trials for potential…
六种新药获推荐批准 欧洲药品管理局（EMA）的人用药品委员会（CHMP）在其2026年10月会议上推荐批准六种药物。Rasonque（daraxonrasib）…，CHMP统计 2026年10月CHMP会议的关键数据展示于下图。© 欧洲药品管理局，CHMP统计：…，对新药的肯定性推荐，Foundayo 国际非专利名称（INN）orforglipron 上市许可申请人 Eli Lilly Nederland B.V. 治疗适应证 …的治疗，Rasonque INN daraxonrasib 上市许可申请人 Revolution Medicines Netherlands B.V. 治疗适应证 转移性胰腺…的治疗，Yuviwel INN navepegritide 上市许可申请人 Ascendis Pharma Growth Disorders A/S 治疗适应证
Six new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended six medicines for approval at its October 2026 meeting.Rasonque (daraxonrasib)…, CHMP statistics Key figures from the October 2026 CHMP meeting are represented in the graphic below. © European Medicines Agency , CHMP statistics:…, Positive recommendations on new medicines, Foundayo International non-proprietary name (INN) orforglipron Marketing authorisation applicant Eli Lilly Nederland B.V. Therapeutic indication Treatment of…, Rasonque INN daraxonrasib Marketing authorisation applicant Revolution Medicines Netherlands B.V. Therapeutic indication Treatment of metastatic pancreatic…, Yuviwel INN navepegritide Marketing authorisation applicant Ascendis Pharma Growth Disorders A/S Therapeutic indica
欧洲药品管理局的人用医药产品委员会（CHMP）已建议授予Rasonque（daraxonrasib）在欧盟的上市许可，该药是一种口服治疗药物，用于患有……的成人患者。
EMA’s human medicines committee (CHMP) has recommended granting a marketing authorisation in the European Union for Rasonque (daraxonrasib), an oral treatment for adults with…
今天，作为其加强卫生信息系统和改善健康[1]承诺的一部分，尤其是在COVID-19大流行的背景下，世界卫生组织宣布了一项改善救生数据可及性的新方法：SCORE卫生数据技术包。COVID-19大流行突显了及时可靠的数据对推动战略卫生行动的迫切需要。仍有太多国家既缺乏常规收集卫生数据的基础设施，也缺乏利用这些数据开展有效卫生行动和应急响应的分析能力。“各国必须能够衡量进展，才能取得进展，”世卫组织总干事谭德塞博士说。“尤其是在COVID-19期间，可靠的数据是协调应对工作、改善对公共卫生威胁的应对和恢复的最佳途径。”
Today, as part of its commitment to strengthening health information systems and improving health[1], especially in the context of the COVID-19 pandemic, WHO announced a new approach to improving access to life-saving data: the SCORE for Health Data Technical Package. The COVID-19 pandemic has highlighted the urgent need for timely and reliable data to drive strategic health action. Too many countries still lack both the infrastructure to routinely gather health data and the analytical capacity to use these data for effective health actions and emergency response. “Countries must be able to measure progress to make progress,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus. “Particularly during COVID-19, reliable data is the best way to coordinate response efforts and improve healt
兽用药品委员会关于兽用药品的意见委员会在特殊情况下通过了关于Bovilis Lumpyvax（疙瘩…）上市许可的积极意见。
CVMP opinions on veterinary medicinal productsThe Committee adopted a positive opinion, in exceptional circumstances, for a marketing authorisation for Bovilis Lumpyvax (lumpy…
欧盟临床试验加速计划（ACT EU）咨询试点项目旨在帮助申办者准备临床试验申请，将从2027年1月起成为一项常设举措……
The Accelerating Clinical Trials in the EU (ACT EU) advice pilot, which helps sponsors prepare clinical trial applications, will become a permanent initiative from January 2027…
在月度会议上，EMA的安全委员会（PRAC）履行了其管理药品安全的广泛职责，包括安全性评估…，议程 2026年9月28日至10月1日PRAC会议议程草案参考编号：EMA/PRAC/204838/2026…，PRAC统计：2026年10月 基于草案议程的PRAC结果月度数据。© 欧洲药品管理局，PRAC统计：…，进行中的转介 程序：肠外给药的含铁药品——转介，术语表 安全性信号评估。安全性信号是指提示存在新的潜在因果关联，或已知关联的新方面的信息…
At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities to manage the safety of medicines, including the assessment of safety…, Agenda Agenda of the PRAC meeting 28 September - 1 October 2026Draft Reference Number: EMA/PRAC/204838/2026…, PRAC statistics: October 2026 Monthly figures for PRAC outcomes based on the draft agenda. © European Medicines Agency, PRAC statistics:…, Ongoing referrals Procedure: Parenteral iron-containing medicinal products - referral, Glossary Safety signal assessments. A safety signal is information which suggests a new potentially causal association, or a new aspect of a known association between…
希望在2026年收到结果的上市许可持有人应提交IA类年度更新、单独的IA类和IAIN类变更，以及超级分组……
Marketing authorisation holders wishing to receive an outcome in 2026 should submit type IA annual updates, individual type IA and type IAIN variations, and super-groupings…
执行董事的2026年年中报告EMA向管理委员会提交了其2026年上半年的运营成果和成就。在一月和……之间。
Mid-year report 2026 from the Executive DirectorEMA presented results and achievements of its operations for the first half of 2026 to the Management Board. Between January and…
欧洲药品管理局（EMA）已认可国际药品监管机构联盟（ICMRA）的联合声明，该声明呼吁药物开发者、制造商、监管机构以及……
EMA has endorsed a joint statement from the International Coalition of Medicines Regulatory Authorities (ICMRA) calling on medicine developers, manufacturers, regulators and…
阿姆斯特丹，2026年9月28日 以实际演讲为准（正式发布的文本基于事先准备的讲稿。实际演讲中可能有细微差异） 早上好，……
Amsterdam, 28 September 2026Check against delivery (The published text is based on the prepared speech. Minor differences may have occurred during delivery)Good morning,…
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全过程中如何考虑女性健康方面作出决定性变革。这……，女性仍然缺位：从研究到数据、预防、诊断和治疗中皆是如此。但改善女性健康支持的势头从未如此强劲。……，有意义的变革始于对话，始于对我们所面临挑战的共同理解。我们以一条明确的行动路径结束本次研讨会。“国家监管……”，本次多方利益相关者研讨会进行了直播，汇集了来自欧盟和国际层面100多位女性健康领域的权威声音，涵盖从监管者到患者、医疗保健……
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…, 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.…, 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…, 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…