Real-world studies (RWSs) data are based on real medical scenes and reflect clinical facts. Besides, RWSs adapts to the characteristics of therapeutic principles of traditional Chinese medicine and the medical reality of the combination of Western and traditional Chinese medicine, which makes the safety assessment of herb-drug interaction more efficient and economical. During RWSs, more attention should be paid on the validity and reliability of data, especially the standardization of the data collection process and its contents. The safety assessment of herb-drug interaction will combine the methods of active surveillance study, big data analysis, and be based on precision medicine in the future