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2010年国际上将药品监管科学的重点领域定为四个维度：安全、有效、质量和性能，强化药品综合性能评估成为贯穿药物全生命周期监管的新标杆。中药监管的本质就是全生命周期的获益-风险评估，中药监管科学新工具新方法在推进构建符合中药特点的审评审批体系发挥重要作用。2023年发布的中药监管科学定义，立足“安全、有效、质量、性能”多维评估整合理念，首次将性能纳入中药新药注册监管第四个核心评价维度，可以更好适配中药整体观、复方配伍、长期临床应用的特点，进一步强化了中药获益-风险评估(Benefit-risk assessment, BRA)的多元化系统性评估范式转变，反映出中西医药监管相互借鉴、协同发展的大势。近年发展起来“中医药理论、人用经验和临床试验相结合”(“三结合”)证据体系作为一种全新的、更具包容性与科学性的中药监管科学综合性能评估新工具，能够重塑中药新药从临床发现到注册上市的完整逻辑，驱动研发理念从“被动合规”向“主动价值创造”深刻转型。“三结合”可以作为中药新药性能评估的重要工具，在研发早期通过中医药理论及人用经验识别临床价值、评估前置风险，并依据证据强度灵活决定临床试验路径，实现“按需供给证据”的最优化决策，对于医疗机构新药研发、个性化临床研究设计、注册沟通交流及上市后动态评估，加快中药新药上市发挥重要作用。
Abstract：In 2010,the international community identified four core dimensions as the key areas of pharmaceutical regulatory science: safety, efficacy, quality, and performance. Strengthening the comprehensive performance assessment of drugs has become a new benchmark for regulation throughout the entire drug life cycle. The essence of traditional Chinese medicine(TCM) regulation lies in conducting benefit-risk assessments throughout the entire life cycle, and new tools and methods in TCM regulatory science play a crucial role in advancing the establishment of a review and approval system that conforms to the characteristics of TCM. The definition of TCM regulatory science published in 2023,based on the integrated concept of multi-dimensional assessment encompassing “safety, efficacy, quality, and performance”,incorporated “performance” as the fourth critical dimension for the registration and regulation of new TCM drugs for the first time. This better accommodates the holistic view, compound compatibility, and long-term clinical application characteristics of TCM,further reinforces the diversified and systematic paradigm shift in benefit-risk assessment(BRA) of TCM,and reflects the broader trend of mutual learning and coordinated development between Chinese and Western pharmaceutical regulation. In recent years, the “three-in-one” review evidence system(including TCM theory, human use experience, and clinical trials) has emerged as a novel, more inclusive, and scientifically sound new tool for comprehensive performance evaluation in TCM regulatory science. This system can reshape the complete logic of new TCM drug development from clinical discovery to registration and marketing, driving a profound transformation in research and development(R&D) philosophy from “passive compliance” to “active value creation”. The “three-in-one” system can serve as avital tool for performance assessment of new TCM drugs. In the early stages of R&D,it identifies clinical value and pre-assesses risks through TCM theory and human use experience, while flexibly determining the clinical trial pathways based on evidence strength, thereby achieving optimal decision-making with “on-demand evidence supply”. This system plays an important role in accelerating the market launch of new TCM drugs in areas such as new drug R&D in medical institutions, personalized clinical study design, registration communication, and post-marketing dynamic evaluation.
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基本信息:
DOI：10.13412/j.cnki.zyyl.20260428.002
中图分类号:R288
引用信息:
[1]李东影,华桦,房军,等.中药新药的性能评估：“三结合”证据体系作为中药监管科学新工具的重要作用[J].中药药理与临床,2026,42(05):2-14+47.DOI:10.13412/j.cnki.zyyl.20260428.002.
2026-04-29
2026-04-29
2026-04-29