ABSTRACT
OBJECTIVE: To make a comparative analysis on the expedited approach for new drug review in the USA, the European Union, and Japan, and to provide references for China. METHODS: Through analyzing the mechanism and implementation performance of each expedited approach, and summarizing its characteristics, this paper puts forward some suggestions according to the situation of the reform for new drug review in China. RESULTS: Compared with the US, EU and Japan, our country is gradually laying emphasis on the value of clinical curative effect when to apply expedited approach, but there is still a large gap on system setting. CONCLUSION: Hence this paper suggests to draw lessons from foreign "multi-channel, full coverage" concept, and gradually to establish a new multi-channel system of expedited review approach on the basis of perfecting our country's priority review approach, thereby accelerating the process of new drugs which have high clinical value.