Expert consensus on applicability assessment of real-world data of hospital-prepared traditional Chinese medicine formulations
LI Qing-na
LU Fang
GAO Rui
Abstract：With the establishment of the"three-pillar"evidence system for traditional Chinese medicine(TCM)registration evaluation,integrating TCM theory,accumulated human experience,and clinical trials,utilization of human experience has become a crucial aspect in the research and development of TCM new drugs.Hospital-prepared TCM formulations,characterized by fixed formulations and advantages in collecting human experience evidence,serve as a vital source for TCM new drug transformation.The applicability assessment of real-world data(RWD)of hospital-prepared TCM formulations to support drug development is a prerequisite for conducting real-world studies(RWS).This article introduces the expert consensus on applicability assessment of real-world data of hospital-prepared traditional Chinese medicine formulations.The consensus encompasses the interpretation of applicability items for general requirements,source data,and governed data,and discusses essential documentation for applicability assessment,presentation of evaluation results,considerations of TCM characteristics,as well as data integrity and security.It is expected that this consensus will further promote the transformation of hospital-prepared TCM formulations into innovative TCM drugs.
Keywords：hospital-prepared traditional Chinese medicine formulationsreal-world dataapplicability assessmenttransformation of traditional Chinese medicine new drugs
Publication Date：2026-01-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：8( 113-120 )