Circular of Center for Drug Evaluation, NMPA on Publishing the Guideline for Writing of Application Documents for Traditional Chinese Medicine (TCM) Theory of New TCM Compound Preparations (Trial)

In order to speed up the establishment of an evidence system for the registration and evaluation of Chinese medicine which combines the traditional Chinese medicine (TCM) theory, human experience and clinical trial, standardize the writing of application documents for TCM theory and package inserts for TCM compound preparations of classic famous formula, under NMPA deployment, the Center for Drug Evaluation has coordinated formulation of the Guideline for Writing of Application Documents for Traditional Chinese Medicine (TCM) Theory of New TCM Compound Preparations (Trial) (Attachment 1), and the Guideline for Writing of Package Inserts for TCM Compound Preparations of Classic Famous Formula (Trial) (Attachment 2). In accordance with the Notice of Comprehensive Division, NMPA on Releasing the Technical Guideline for Pharmaceutical Products (YJZYG [2020] 9), after NMPA review and approval, it's hereby released and implemented since the date of release.