Analysis and reflection on the marketing authorization of innovative traditional Chinese medicine drugs since 2020
WU Chen-yue
HAN Wei
QU Jian-bo
TANG Zhen
WANG Zhang-wei
SHEN Xiang-rong
YANG Chang-ming
Abstract：The Chinese government prioritizes the inheritance and innovation development of traditional Chinese medicine(TCM).It emphasizes strengthening innovation in TCM research and development(R&D),focusing on major chronic diseases,refractory disorders,emerging infectious diseases,and environmentally associated conditions,to accelerate the launch of innovative TCM drugs with outstanding clinical efficacy and distinct therapeutic advantages.This article systematically analyzed the innovative TCM drugs approved since the enactment of the Drug Registration Regulation in 2020,aiming to serve as a medication reference for clinicians and promote the clinical use of innovative TCM drugs.Our multidimensional analysis included the quantity and registration categories of approved drugs,composition of ingredients in TCM preparations,routes of administration and dosage forms,therapeutic functions and indications,evidence supporting market approval,as well as the review and approval procedures.The finding revealed that with the implementation of policies supporting the inheritance and innovation of TCM,deeper regulatory science research,continuous enhancement of evaluation standards system including efficacy assessment methods and quality control,and ongoing optimization of the review and approval mechanisms,the R&D of innovative TCM drugs is increasingly prioritizing clinical value-oriented paradigm.Greater emphasis is placed on leveraging human experience as evidence to support R&D decisions and regulatory submissions.Consequently,more high-quality innovative TCM drugs with significant clinical value are anticipated to enter the market,better meeting public medication needs.
Keywords：innovative traditional Chinese medicinemarketing authorizationclinical medicationregistration categoriestraditional Chinese medicine regulatory science
Publication Date：2025-11-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：8( 2358-2365 )