This paper describes the reasons for the reform of the evaluation and approval system of traditional Chinese medicine (TCM) in 2020, elaborates the contents of its reform of the registration classification in detail. Several innovative ideas of the reform were discussed, including the three-combined evidence system, the quality control and clinical positioning in new TCM research and development. This paper also announces the schedule of the reform implementation regarding evaluation and approval system of TCM, providing important guidance for the research and development of new TCM.

traditional Chinese medicine  /  evaluation  /  new drug research and development  /  registration  /  reform  /  system