临床试验申请咨询试点转为常设
正文 · 中文译文
欧盟加速临床试验（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月起成为永久性举措。该举措通过加强欧洲药品监管网络内的合作，有助于提高申请质量，提升临床试验评估流程的效率。 该咨询程序由药品机构负责人（HMA）通过其临床试验协调组（CTCG）协调，在申办者通过临床试验信息系统（CTIS）提交临床试验申请之前，为其提供技术和监管支持。自2024年启动以来，该试点项目通过汇集相关成员国对关键的提交前主题的整合反馈意见，帮助申办者提高了申请质量。 在该试点项目推出之前，申办者只能从负责评估其申请的成员国处获得国家层面的技术和监管支持。 转为永久性举措将确保持续为在通过CTIS提交临床试验申请前寻求指导的申办者提供支持。ACT EU将继续管理在试点项目下已提交的申请，直至2026年底。一份总结约30份试点申请经验教训的最终报告将在2026年底前发布。供申办者使用的最新指南文件和模板将于2027年1月在CTCG网站上提供。 向永久性举措的过渡通过帮助临床试验申办者更有效地驾驭欧盟临床试验框架，支持了欧洲生物技术法案的目标。 电话 +31 (0)88 781 8427 电子邮件：press@ema.europa.eu
正文 · 英文原文
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. The initiative contributes to higher-quality applications and more efficient clinical trial assessment processes, by strengthening cooperation across the European medicines regulatory network. The advice procedure, coordinated by the Heads of Medicines Agencies (HMA) through its Clinical Trials Coordination Group (CTCG), provides sponsors with technical and regulatory support before they submit a clinical trial application through the Clinical Trials Information System (CTIS). Since its launch in 2024, the pilot has helped sponsors improve the quality of their applications by providing consolidated feedback from the Member States concerned on key pre-submission topics. Before the introduction of this pilot, sponsors could only receive technical and regulatory support at a national level from the Member State responsible for evaluating their application. The transition to a permanent initiative will ensure continued support for sponsors seeking guidance before submitting clinical trial applications through CTIS. ACT EU will continue to manage applications already submitted under the pilot until the end of 2026. A final report summarising lessons learned from approximately 30 pilot applications will be published before the end of 2026. Updated guidance documents and templates for sponsors will be made available on the CTCG website in January 2027. The transition to a permanent initiative supports the objectives of the European Biotech Act by helping clinical trial sponsors navigate the EU clinical trials framework more effectively. Tel. +31 (0)88 781 8427 E-mail: press@ema.europa.eu