Abstract: In 2018， the State Food and Drug Administration issued the administrative provisions on simplified registration and approval of ancient classical prescription， which made it clear that the application for listing of classical prescription could only provide pharmaceutical and non-clinical safety research data. The pharmacodynamic research and clinical trial data were not required to be provided. The regulation caused a heated discussion after its promulgation. In this paper， we briefly discussed the rationality of the drug efficacy and clinical research free of classical prescription， so as to provide a reference for clarifying the connotation of relevant policies， promoting the R&D and approval of classic famous prescription.