The adverse reactions caused by traditional Chinese medicine have occurred frequently, but there is a lack of scientific, objective and standardized methods for safety evaluation of traditional Chinese medicine. In the process of preclinical evaluation of traditional Chinese medicine, it is imperative to form a set of scientific, standardized and feasible evaluation system of modem Chinese herbal drug. We established the preclinical safety evaluation system of modem Chinese herbal drug including the quality control system of samples for the preclinical safety evaluation, the toxicity evaluation system of modem Chinese herbal drug and its preparation and the evaluation management system, and standardized each research link of preclinical evaluation of traditional Chinese medicine. Whether from protecting patients' health and increasing the safety of clinical medication, or from enriching and improving traditional Chinese medicine science, developing traditional Chinese medicine and promoting mutual connection of traditional Chinese medicine and international medicine, it has important instructional significance and application value.