摘要
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 Chi-nese 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",incor-porated"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 characteris-tics 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 pharmaceu-tical regulation.In recent years,the"three-in-one"review evidence system(including TCM theory,human use experi-ence,and clinical trials)has emerged as a novel,more inclusive,and scientifically sound new tool for comprehensive per-formance evaluation in TCM regulatory science.This system can reshape the complete logic of new TCM drug develop-ment 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 a vital 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 institu-tions,personalized clinical study design,registration communication,and post-marketing dynamic evaluation.关键词
中药新药注册/有效性/安全性/质量/性能/"三结合"审评证据体系/获益-风险评估/中药监管科学Key words
Registration of new traditional Chinese medicines/Efficacy/Safety/Quality/Performance/"Three-in-one"review evidence system/Benefit-risk assessment/Traditional Chinese medicine regulatory science
