【摘要】 面对生命科学的不断发展和国际地缘政治的急剧变化，全球药品监管环境正处在深刻变革阶段。在传统意义上依托国际标准加强合作，不断提升监管能力的基础上，全球药品监管机构正在探索从协调、趋同直至信赖的通路。为此，世界卫生组织（WHO）在原有的产品预认证和国家监管机构（NRA）评估以及所谓严格监管机构（SRA）认定模式基础上，于2017年提出“WHO列名机构（WLA）”新概念。WLA以全球基准评估工具（GBT）和绩效评估（PE）为核心，旨在为国际药品及疫苗监管构建一个统一、透明和科学的评估平台，并据此推进全球药品监管实质性合作。本文详细回顾了WLA的产生背景与演变历程，系统介绍GBT和PE两大评估工具的构建、内容与实施流程，并对各国和地区监管机构在WLA评估中的实践路径进行分析。最后探讨了WLA在推动全球药品监管信赖、提升监管质量及保障国际药品供应中的战略意义。更多还原

【Abstract】 With the continuous development of life sciences and the dramatic change of global geopolitics, the international drug regulatory landscape is undergoing rapid transformation. Building upon traditional international cooperation mechanisms centered on harmonization through global standards and the strengthening of regulatory capacity, regulatory authorities worldwide are now exploring pathways that progress from harmonization and convergence toward reliance. In response to this trend, the World Health Organization(WHO) introduced the concept of the "WHO Listed Authority"(WLA) in 2017, based on its existing prequalification program and the Global Benchmarking Tool(GBT) for National Regulatory Authorities(NRAs), as well as the recognition model for Stringent Regulatory Authorities(SRAs). Anchored in the GBT and Performance Evaluation(PE) frameworks, the WLA aims to establish a unified, transparent, and science-based evaluation platform to foster effective global cooperation in drug and vaccine regulation. This paper reviews the background and evolution of the WLA framework, systematically presents the structure, content, and implementation processes of the GBT and PE assessment tools, and analyzes the practical approaches taken by various national and regional authorities in their WLA assessments. Finally, it discusses the strategic significance of the WLA framework in strengthening international regulatory reliance, improving regulatory quality, and ensuring the security and stability of the global pharmaceutical supply chain.更多还原