OBJECTIVE: To provide reference for improving drug priority review system in China. METHODS: Introduce the drug special review system in China, the basic content and characteristics, implementation and problems of drug priority review system, the characteristics of drug priority review system in USA, the European Union, Japan were analyzed to put forward the suggestions for improving drug priority review system in China. RESULTS & CONCLUSIONS: The special review system has been established in China, such as special approval, special review and priority review. In 2017, the scope of drug priority review, communication mechanism, submission of materials, withdrawal mechanism and conditions approval were stated in Opinions of the General Administration on Encouraging Drug Innovation and Implementing Priority Review and Approval published and implemented by State Administration of Food and Drug Supervision. By the end of 2017, more than 400 drug registration approvals were included in drug priority review list, among which two-thirds had completed the review, but the application of class 1 new drug is still not satisfactory. At present, there are still shortcomings in the system (such as wide range of acceptance, unclear inclusion standards, unclear regulation), review procedure (such as review time limit and unclear procedure) and review mechanism (such as poor operability) in China. United States, the European Union and Japan have formulated an efficient and pragmatic drug priority review system, including multi-channel, multi-mode and multi-mechanism priority review system, comprehensive system, clear procedure, strong operability, emphasis on guidance, and attention to supervision and so on. In view of the above problems, based on other national characteristics, it is suggested to standardize and refine system and the review procedure, strengthen the system construction, strengthen the rigor and normalization of the review, optimize the review mechanism, strengthen the whole process connection, improve and optimize drug priority review system in China.