OBJECTIVE:To provide suggestions for the development of training mode for pharmaceutical monitoring personnel in China.METHODS:The training mode of Office of Regulatory Affair University(ORA U) was introduced to analyze the difference of training mode for pharmaceutical monitoring personnel between China and America.RESULTS & CONCLUSIONS:America has established a systematic,continuous and uniform pharmaceutical monitoring personnel training system,which is more flexible and advanced than that in China.Our country could draw experiences from the training mode of FDA personnel to develop uniform and diversified training system with suitable budget mechanism.