There is high similarity between real-world study (RWS) and the clinical practice of traditional Chinese medicine (TCM). RWS can be used as one of the methods to collect the empirical data of human use normatively, and generate high-quality empirical evidence of human use of TCM. From the perspective of the whole life cycle of TCM, RWS can not only help to choose the subject and set up the project, optimize the strategy of TCM research and develop (R&D), shorten the R&D period, guide the pharmacological and toxicological research and clinical trial design, improve the research efficiency, but also continuously explore the clinical value and extend the life cycle of products. In view of the deficiencies in the quality of real-world data and the methodology for using real-world data needing to be standardized, it is necessary to clean up the data to form applicable analysis data, and form the truth through standardized methodological design, well organized implementation, and reasonable statistical analysis. Exploring the safety and effectiveness of TCM with the real-world evidence would support the research and development of new TCM products with human experience.