EMA管理委员会：2026年9月会议要点
正文 · 中文译文
EMA向管理委员会提交了其2026年上半年运营的成果与成就。1月至6月期间，新人类药物（孤儿药和非孤儿药）的申请数量与去年持平，保持在同等高水平，共收到29份申请。关于兽药，管理委员会注意到，2026年上半年收到了7份初始上市许可申请，而2025年同期为12份。人类药物和兽药物的科学建议请求均显著增加，这表明开发者对于将其创新药物带给欧盟患者保持持续的兴趣。 管理委员会欢迎欧洲药品管理局（EMA）在准备实施新药品立法和关键药物法案方面取得的进展，包括为加强欧盟范围内关键药物的可及性和供应所采取的措施。管理委员会还注意到该机构通过强化PRIME支持、实施卫生技术评估（HTA）法规、推进ACT EU下的临床试验举措以及扩展DARWIN EU来持续支持创新，以生成高质量的真实世界证据来补充监管决策。它还欢迎欧洲药品监管网络数字化转型方面的持续进展，包括数据和人工智能举措方面的进展。这项工作建立在《欧洲药品机构网络2028年战略》（EMANS 2028）基础之上，并以该机构打造从创新到安全有效药物的快速路径这一愿景为指导。 2026年中期报告将于近期发布。 新欧盟药品立法实施准备工作 实施新欧盟药品立法（NPL）的准备工作正在积极推进。欧洲药品管理局正在与欧盟委员会和欧洲药品监管网络共同推进新立法关键方面的实施。许多领域已完成大量工作。已确定优先推动尽早生效的举措，如优先抗生素的可转让专有权凭证、监管沙箱和短缺管理。 有关实施活动的最新信息将通过欧洲药品管理局（EMA）的各个沟通渠道提供给利益相关方，特别是EMA网站上的NPL中心页面。 关于下一任EMA执行主任提名和任命的实际程序安排已提交给管理委员会。一旦欧盟委员会提交候选人短名单，将召开管理委员会特别会议。概述这些安排的文件已经发布。您也可以参阅我们的信息表中的流程。 临床试验信息系统——为拟议的《生物技术法案》做准备 管理委员会听取了关于临床试验信息系统（CTIS）进展的最新汇报，包括未来发展计划。自2022年启动以来，CTIS已支持欧洲超过14,000项临床试验的授权和管理，每月收到超过200份新的临床试验申请。作为覆盖所有欧盟成员国的单一临床试验系统，CTIS使《临床试验法规》得以实施，加强了跨境合作，并提高了药物开发的透明度，增强了公众对药物开发的信任。一项CTIS现代化计划已于2025年启动，以确保系统能够为随着时间的推移而不断增加的试验数量做好准备。 董事会还听取了在欧盟委员会于2025年12月通过的《生物技术法案》提案的背景下，临床试验信息系统（CTIS）开发计划的介绍。预计在该立法通过后，CTIS将尽快支持《生物技术法案》的关键功能。立法提案中对临床试验授权和监管的拟议变更将影响当前CTIS约70%的功能。这些变更包括：实现更快速的临床试验评估，为正在进行的试验的重大修改提供更大灵活性，加强成员国之间的合作，支持更相称的、基于风险的授权程序，共同药品档案，以及简化涉及药品、医疗器械和体外诊断试剂的联合研究的评估。 目前，《生物技术法案》的提案正在欧洲理事会和欧洲议会讨论中。根据为立法程序设定的雄心勃勃的时间表，对临床试验法规的首次修改可能最早于2028年初生效。欧盟委员会在管理委员会成员的支持下，表示迫切需要EMA加快推进准备工作。在此基础上，管理委员会强调了尽早交付关键的CTIS功能（包括加速审评时间表）并及时赶上《生物技术法案》通过的重要性。为实现这一目标，当前CTIS平台需要立即投资。《生物技术法案》所预见的全部临床试验功能计划将在新的现代化CTIS平台上交付，相关工作将于2027年初启动。一份详细的路线图（包括资源影响），用于交付新的CTIS功能，将于2026年12月提交给管理委员会。 下一位EMA执行主任的提名和任命程序 数据分析和真实世界数据查询网络（DARWIN EU） 电话：+31 (0)88 781 8427 电子邮箱：press@ema.europa.eu
正文 · 英文原文
EMA presented results and achievements of its operations for the first half of 2026 to the Management Board. Between January and June, applications for new human medicines (orphan and non-orphan) remained at the same high level as last year, with 29 applications received. For veterinary medicines, the Board noted that seven initial marketing authorisation applications had been received in the first half of 2026, compared with 12 in the same period in 2025. There has been a significant increase in requests for scientific advice for both human and veterinary medicines, indicating a sustained interest by developers to bring their innovative medicines to patients in the EU. The Board welcomed EMA's progress in preparing for the implementation of the new pharmaceutical legislation and the Critical Medicines Act, including measures to strengthen the availability and supply of critical medicines across the EU. The Board also noted the Agency’s continued support for innovation through enhanced PRIME support, implementation of the Health Technology Assessment (HTA) Regulation, progress in advancing clinical trial initiatives under ACT EU and the expansion of DARWIN EU, to generate high-quality real-world evidence to complement regulatory decision-making. It also welcomed continued progress in the digital transformation of the European Medicines Regulatory Network, including advances in data and artificial intelligence initiatives. This work builds on the European Medicines Agencies Network Strategy to 2028 (EMANS 2028) and is guided by the Agency's vision of creating a fast path from innovation to safe and effective medicines. The 2026 mid-year report will be published shortly. Preparations for implementation of the new EU pharmaceutical legislation Preparations for implementing the new EU pharmaceutical legislation (NPL) are well underway. EMA is advancing the implementation of key aspects of the new legislation jointly with the European Commission and the European Medicines Regulatory Network. Significant work has been done in many areas. Initiatives that are earmarked for early entry into force, such as transferable exclusivity vouchers for priority antibiotics, the regulatory sandbox and management of shortages have been prioritised. Up-to-date information on implementation activities will be provided to stakeholders across EMA’s communication channels, particularly the NPL hub page on the EMA website. The practical procedural arrangements for the nomination and appointment of the next EMA Executive Director were presented to the Board. An extraordinary Board meeting will be convened once the European Commission has submitted a shortlist of candidates. The document outlining the arrangements has been published. You can also refer to the process in our info sheet . Clinical Trials Information System – preparing for the proposed Biotech Act The Board was updated on progress with the Clinical Trials Information System (CTIS) including future development plans. Since its launch in 2022, CTIS has supported the authorisation and management of more than 14,000 clinical trials in Europe, with more than 200 new clinical trial applications received each month. Operating as a single system for clinical trials across all EU Member States, CTIS enables the operation of the Clinical Trials Regulation, enhances cross-border collaboration and increases transparency and public trust in medicines development. A modernisation initiative for CTIS started in 2025 to ensure the system is prepared for the increasing number of trials submitted over time. The Board also heard plans for development of CTIS, in the context of the proposal for a Biotech Act, adopted by the European Commission in December 2025. The expectation is that CTIS will support key Biotech Act functionalities as soon as possible, following the adoption of the legislation. The proposed changes to authorisation and supervision of clinical trials in the legislative proposal impact approximately 70% of the current CTIS functionality. They include enabling faster clinical trial assessments, providing greater flexibility for major modifications to ongoing trials, strengthening collaboration between Member States, supporting a more proportionate, risk-based authorisation procedures, common medicinal product dossiers and simplifying the assessment of combined studies involving medicines, medical devices and in vitro diagnostics. At present, the proposal for the Biotech Act is under discussion in the European Council and Parliament. According to the ambitious timeframe set for the legislative procedure, first changes to the clinical trials regulation could already come into force in early 2028. The European Commission, supported by Board Members, expressed urgency for EMA to advance preparations. On this basis, the Board emphasised the importance of delivering key CTIS functionalities, including accelerated assessment timelines, as early as possible and in time for the adoption of the Biotech Act. To enable this, the current CTIS platform will need immediate investment. All clinical trials functionality foreseen by the Biotech Act is planned to be delivered in a new modern CTIS platform, and work will start on this in early 2027. A detailed roadmap, including resource impact, for the delivery of new CTIS functionalities will be presented to the Board in December 2026. Proceedings for the nomination and appointment of the next EMA Executive Director Data Analysis and Real World Interrogation Network (DARWIN EU) Tel. +31 (0)88 781 8427 E-mail: press@ema.europa.eu