In order to speed up the construction of the evidence system for TCM registration evaluation combining TCM theory, experiences in human use and clinical trials, and standardize the preparation of application dossiers of TCM theory and the package inserts of compound preparations of Chinese medicines in ancient classic prescriptions, under the deployment of the National Medical Products Administration, the CDE has organized to formulate the Guidance for the Preparation of Application Dossiers for TCM Theory of Compound Preparations of New Chinese Medicines (interim) and the Guidance for the Preparation of the Package Inserts of Compound Preparations of Chinese Medicines in Ancient Classic Prescriptions (interim), which has, per the requirements of the Notice of the NMPA Comprehensive Department on Issuing the Release Procedures for Pharmaceutical Technical Guidance, been issued and implemented on October 15, 2021 upon the review and approval by the National Medical Products Administration.