全球监管机构呼吁在药物全生命周期推进动物试验的替代方法。
正文 · 中文译文
欧洲药品管理局（EMA）认可了国际药品监管机构联盟（ICMRA）的一份联合声明，该声明呼吁药物开发者、生产商、监管机构和国家质控实验室在人类药物全生命周期中，尽可能且尽快地继续推进和实施动物试验的替代方法或途径。 EMA长期以来致力于3Rs原则——在药物开发和监管中替换、减少和优化动物的使用。由于药物在全球环境中开发和监管，减少动物使用的实质性进展取决于全球范围内对科学有效且符合3Rs要求的方法的开发及监管认可。通过ICMRA促进监管方法的国际协调与统一是这一工作的核心。 该联合声明的制定由欧洲药品管理局（EMA）、英国药品和健康产品管理局（MHRA）、爱尔兰健康产品监管局（HPRA）以及瑞士治疗产品管理局（Swissmedic）牵头。该声明经ICMRA全体会议通过，阐述了在药品生命周期的所有阶段取代动物试验的长期目标：从初始候选药物筛选和早期开发，到临床前和非临床测试，再到许可和上市后活动。实现这一目标需要谨慎、分阶段地向非动物方法过渡，这些方法应具有科学有效性并可供监管机构接受，同时需要强有力的证据以及监管机构、药物开发者和替代方法创新者之间开放的国际互动。 对于新药，从开发到上市许可，ICMRA呼吁： 全球药物开发者采用不涉及使用动物且可在监管背景下接受的方法，同时保障科学质量； 国际药品监管机构尽可能支持和促进这些努力。 认识到在满足监管要求方面减少动物使用所能产生的最大影响将通过采用非动物方法进行批次放行检测来实现，ICMRA还呼吁国际监管机构： 鼓励开发和采用用于批次放行目的的非动物试验，并对提出将动物用于批次放行检测的情况提出质疑； 只有在科学上有充分理由证明没有等效或更优的非动物方法可用时，才批准体内批放行试验； 酌情审查和修订现有的批放行体内试验要求。 ICMRA声明承认，不同的地区和国家将以不同的速度接受向不进行动物试验的药物开发、许可和批放行的转变。ICMRA鼓励药品制造商、开发者和监管机构共同努力，以推动这一渐进式范式转变，并尽可能支持协调一致的实施。 在欧盟层面，已经确立了朝着创新性非动物方法迈进的明确方向。6月，欧盟委员会发布了一份关于在化学品安全性评估中逐步淘汰动物试验的路线图，其中列出了确保这一转变的具体步骤。此外，在减少批放行试验中动物使用方面已经取得了很大进展。从2015年到2023年，用于药品监管目的的年度动物使用总数大约减少了一半。 国际药品监管机构联盟（ICMRA） ICMRA关于人用药物动物试验的声明 英国药品和健康产品管理局（MHRA） 瑞士治疗产品管理局（Swissmedic） 委员会加快化学品安全性评估中摆脱动物试验的转型（01/06/2026） ALURES统计——第2部分：用于研究、检测、常规生产以及教育和培训目的的动物使用情况——欧盟关于用于科学目的的动物使用情况统计数据库 电话：+31 (0)88 781 8427 电子邮件：press@ema.europa.eu
正文 · 英文原文
EMA has endorsed a joint statement from the International Coalition of Medicines Regulatory Authorities (ICMRA) calling on medicine developers, manufacturers, regulators and national control laboratories to continue to advance and implement alternative methods or approaches to animal testing throughout the lifecycle of human medicines, wherever, and as soon as possible. EMA has a longstanding commitment to the 3Rs principles – to replace, reduce and refine the use of animals in medicines development and regulation. Because medicines are developed and regulated in a global environment, meaningful progress in reducing animal use depends on the worldwide development and regulatory acceptance of scientifically valid, 3Rs-compliant approaches. Promoting international alignment and harmonisation of regulatory approaches through ICMRA are central to this effort. The development of the joint statement was led by EMA, the UK Medicines and Healthcare products Regulatory Agency (MHRA), the Irish Health Products Regulatory Authority (HPRA) and Swissmedic, the Swiss Agency for Therapeutic products. Adopted by the ICMRA plenary, the statement sets out the long-term goal of replacing animal testing throughout all stages of a medicine’s lifecycle: from initial candidate screening and early development, through pre-clinical and non-clinical testing to licensing and post-authorisation activities. Achieving this will require a cautious and stepwise transition to non-animal methods that are scientifically valid and acceptable for regulatory authorities, supported by robust evidence and open global interaction between regulators, medicine developers and innovators of alternative approaches. For new medicines, from development to authorisation, ICMRA calls on: medicine developers globally to employ methods that do not involve the use of animals and that are acceptable in a regulatory context while safeguarding scientific quality; international medicines regulators to support and facilitate these efforts insofar as possible. Recognising that the greatest impact in reducing the use of animals to meet regulatory requirements would be achieved by the adoption of non-animal methods for batch release testing, ICMRA also calls on international regulators to: encourage the development and adoption of non-animal tests for batch release purposes, and to challenge instances where animal use for batch release testing is proposed; only approve in vivo batch release testing when scientifically justified that there is no equivalent or superior non-animal methodology available; review and amend as appropriate existing in vivo testing requirements for batch release. The ICMRA statement acknowledges that different regions and countries will move at different paces to accept a transition towards drug development, licensing and batch release without testing in animals. ICMRA encourages medicines manufacturers, developers and regulators to work together to enable this progressive paradigm shift, and to support harmonised implementation as much as possible. At the EU level, a clear direction has been set to progress towards innovative non-animal methods. In June, the European Commission presented a roadmap towards phasing out animal testing for chemical safety assessments, which lays out tangible steps to ensure this transition. In addition, much progress has already been achieved to reduce the use of animals in the context of batch release testing. From 2015 to 2023, overall, the number of animal uses per year for regulatory purposes for pharmaceuticals approximately halved. International Coalition of Medicines Regulatory Authorities (ICMRA) Statement from ICMRA on animal testing for human medicines UK Medicines and Healthcare products Regulatory Agency (MHRA) Swiss Agency for Therapeutic products (Swissmedic) Commission accelerates transition away from animal testing in chemical safety assessments (01/06/2026) ALURES statistics - Section 2: Uses of animals for research, testing, routine production and education and training purposes - EU statistics database on the use of animals for scientific purposes Tel. +31 (0)88 781 8427 E-mail: press@ema.europa.eu