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Abstract：
The UK National Centre for the Replacement, Refinement, and Reduction of Animals in Research (NC3Rs) is reviewing World Health Organization (WHO) manuals, guidelines and recommendations for vaccines and biotherapeutics to identify the extent to which animal-based testing methods are described. The aim is to recommend where updates to these documents can lead to an increased and more harmonised adoption of 3Rs principles (i.e. Replacement, Reduction and Refinement of animal tests) in the quality control and batch release testing requirements for vaccines and biotherapeutics. Improved adoption of 3Rs principles and non-animal testing strategies will help to reduce the delays and costs associated with product release testing. Developing recommendations that are widely applicable by both the manufacturers and national regulatory authorities for vaccines and biological therapeutics globally requires a detailed understanding of how different organisations view the opportunities and barriers to better integration of the 3Rs. To facilitate this, we developed and distributed a survey aimed at individuals who work for national regulatory authorities (NRAs) and/or national control laboratories (NCLs). In this paper, we present the key findings from this survey and how these will help inform the recommendations for wider integration of 3Rs approaches by WHO in their guidance documents applicable to the quality control and batch release testing of vaccines and biotherapeutics.
摘要：
英国国家置换中心，精炼,和减少研究中的动物（NC3Rs）正在审查世界卫生组织（WHO）手册，关于疫苗和生物治疗的指南和建议，以确定描述基于动物的测试方法的程度。目的是建议这些文件的更新可以导致更多和更协调地采用3Rs原则(即替换，减少和改进动物试验）在疫苗和生物治疗剂的质量控制和批量释放试验要求中。改进采用3Rs原则和非动物测试策略将有助于减少与产品发布测试相关的延迟和成本。在全球范围内制定广泛适用于疫苗和生物治疗的制造商和国家监管机构的建议，需要详细了解不同组织如何看待3R更好整合的机会和障碍。为了促进这一点，我们针对为国家监管机构(NRA)和/或国家控制实验室(NCLs)工作的个人制定并分发了一项调查.在本文中,我们介绍了本次调查的主要结果,以及这些结果将如何帮助世卫组织在其适用于疫苗和生物治疗药物质量控制和批量释放测试的指导文件中更广泛地整合3Rs方法的建议.
