Objective: To discuss the evaluation of new traditional Chinese medicines (TCM) which differ from new chemical drugs. Methods: The evaluation idea of new TCM was innovated by using the tool of the realworld evidence (RWE), the method of overall evidence evaluation, and the technical support of the electronic patient-reported outcome (PRO). Results: 1) This article put forward the idea of quality consistency evaluation in the quality control of new TCM. Under the premise of unsatisfactory evaluation of the quality consistency of new TCM in a single angle, the multi-angle review concept of the overall evidence method was used to evaluate the consistency of the efficacy of multiple batches of drugs with RWE, and to appropriately relax the requirements on consistency of the quality of new TCM. It was required to make the consistency evaluation of the efficacy of new TCM as a powerful supplement to the quality consistency evaluation. 2) The idea of clinical efficacy evaluation of new TCM was proposed. Based on the evaluation of traditional clinical trials, the patient-focused clinical trial design was conduted to create electronic PRO, focus on improving the life quality of patients and form supporting evidence for clinical efficacy. Conclusion: To encourage the use of new tools, new methods, new technologies, new ideas, fully embody the pioneering nature of TCM clinical efficacy evaluation methods in the evaluation of new TCM, and innovate the evaluation ideas of new TCM.