OBJECTIVE： To investigate and perfect the pilot work of medicine marketing authorization holder system in China. METHODS： The problems of medicine marketing authorization system in China and the features of medicine marketing licensing system in USA and EU were analyzed. The legal authority and content of pilot medicine marketing authorization holder system in China were summarized so as to propose related policy recommendation. RESULTS & CONCLUSIONS： There are many problems in the medicine authorization system in China which is the combination of “production license” and “marketing license”， for example， the obsolete definition of “new drugs”， the serious waste of drug resources， the insufficient research and development of new drugs. The “production license” and “marketing license” are separated in the USA and EU. There are many new drugs， high capacity utilization and perfect system of drug safety， quality control and risk management. In order to ensure the effective implementation of the pilot work， it is suggested to enhance and improve the quality authorization management， the pharmacovigilance system and drug injury relief related to drug safety management.