Abstract: Objective To explore toxicity, efficacy and pharmacovigilance of traditional Chinese medicine (TCM) based on the property of TCM so as to provide reference for research on and implementation of Chinese medicine pharmacovigilance. Methods Based on related theories, actual clinical medication and experimental research, the factors that influenced the effectiveness and safety of TCM were analyzed, and the relationship between the property, toxicity and efficacy was studied. Meanwhile, a TCM property-based pharmacovigilance model was established. Results Efficacy and toxicity were positive and negative expressions of TCM property, and one could be transformed into the other. Pharmacovigilance of TCM was supposed to start with the property of TCM, which involved advancing our understanding of properties of TCM, facilitating "toxicity to efficacy" transformation, preventing "efficacy to toxicity" transformation and detoxification. Factors including drugs, patients and medication had to be taken into consideration in the whole process of pharmacovigilance by means of quality control, terminal signal monitoring and process warning. Conclusion The medicinal property is the clinical feature of TCM. Pharmacovigilance of TCM calls for keen insights into the property of TCM while giving weight to toxicity and efficacy so as to establish a model of pharmacovigilance that could provide new ideas and guide rational use of TCM.

Key words: traditional Chinese medicine property, traditional Chinese medicine, toxicity, efficacy, pharmacovigilance