背景：基准已越来越多地用于药物监管系统，以实现可持续的药物系统加强。本研究旨在确定研究范围，基准监管能力的工具和好处以及这种现象的最新发展。方法：本研究对来自6个数据库和5个相关组织和政府机构网站的基准药物监管能力的文献和文件进行了综合和严格的审查，符合系统审查首选报告项目（PRISMA）指南。
结果：本综述包括2005年至2022年间发表的43项关于监管基准的研究和6份文件。确定了国际组织或政府机构建议或采用的五种基准评估工具或方案，共涵盖12项主要监管职能(系统一级4项，业务一级8项)，涉及9个指标类别和382个次级指标。据报道，国家采用了基准药物监管系统，区域和国际层面的内部评估(主要是关于监管体系的建立，药物审查过程和上市后监督)或外部评估(主要是监管标准，药物审查过程和药物警戒系统)以评估当前状态，监控性能，确定主要挑战，并为能力建设采取行动提供信息。在监管过程等领域的优先行动，资源分配,合作与沟通,和利益相关者的参与已被建议加强药物监管系统。然而，关于优化监管能力的基准测试的证据仍然被低估。
结论：这一综合审查为决策者描述了一个关于为什么以及如何实施基准药物监管系统的框架。为了有效的基准测试，关于目标的明智决定，范围,参考点和基准工具的选择对于指导实施策略至关重要。有必要对监管基准的积极影响进行进一步的研究，以持续致力于实践。
BACKGROUND: Benchmarking has been increasingly used on drug regulatory systems to achieve sustainable pharmaceutical system strengthening. This study aimed to identify the scope, tools and benefits of benchmarking regulatory capacities and the most recent development in such phenomenon. Method: This study employed an integrative and critical review of the literature and documents on benchmarking drug regulatory capacities identified from 6 databases and 5 websites of related organizations and government agencies in compliance with the Preferred Reporting Items for Systematic Review (PRISMA) guidelines.
RESULTS: Forty-three studies and 6 documents about regulatory benchmarking published between 2005 and 2022 were included in this review. Five benchmarking assessment tools or programmes recommended or adopted by international organizations or government agencies had been identified, which collectively covered 12 major regulatory functions (4 at system level and 8 at operational level) involving 9 indicator categories and 382 sub-indicators. Benchmarking drug regulatory systems was reportedly employed at national, regional and international levels for either internal assessment (mostly on regulatory system establishment, drug review process and post marketing surveillance) or external evaluation (mostly on regulatory standards, drug review process and pharmacovigilance systems) to assess current status, monitor performance, determine major challenges and inform actions for capacity building. Priority of actions in areas such as regulatory process, resources allocation, cooperation and communication, and stakeholder engagement have been suggested for strengthening drug regulatory systems. Nevertheless, the evidence about benchmarking in optimizing regulatory capacities remained underreported.
CONCLUSIONS: This integrative review depicted a framework for decision-makers about why and how benchmarking drug regulatory systems should be undertaken. For effective benchmarking, well-informed decisions about the goals, the scope, the choice of reference points and benchmarking tools are essential to guide the implementation strategies. Further studies about the positive effects of regulatory benchmarking are warranted to engage continuous commitment to the practice.
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