通过学习理解美国食品药品监督管理局(FDA)对植物药的法规和植物药毒理研究审评所依据的指导原则,以及申报植物药的体验,通过分析FDA区别对待植物药的情况,同时对在不同临床申报阶段需开展的毒理研究进行分析,为我国中药制剂在进行FDA申报时所需开展的毒理研究提供参考依据。 Through the study to understand the United States Food and Drug Administration (FDA) guidelines on plant pharmacological regulations and botanical toxicological studies review based on the guidelines and declare the experience of botanicals by analyzing the FDA to distinguish between the situation of botanicals, while The toxicological studies to be carried out in different stages of clinical application are analyzed to provide references for the toxicological studies of Chinese traditional medicine preparations in the process of FDA application.