Abstract: There is a huge demand for pediatric drugs in China.However， there are few types and dosage forms of pediatric drugs in the market， and enterprises lack enthusiasm for research and development as well.In response to this problem， the government departments concerned implemented a series of policy， aimed at speeding up the marketing of pediatric drugs， guaranteeing the supply of pediatric drugs. In this paper， the evaluation and approval policies for pediatric drugs in recent years were firstly reviewed， and the related data for pediatric drugs in recent 6 years is statistically analyzed to investigate the effectiveness of the policies. Secondly， we compare and analyze the evaluation and approval policies for pediatric drugs in USA， EU and Japan. Finally， the future reform direction of the evaluation and approval of Chinese pediatric drugs is put forward. The analysis results show that the pediatric drugs development in China started late， but we can use the beneficial experience and practice from other counties for reference. In order to speed up the marketing and improve the accessibility of pediatric drugs， we should continuously improve relevant policies and regulations of evaluation and approval policies for pediatric drugs， simplify the procedure of evaluation and approval， and set up a specifical department.

Key words: font-size:medium, ">Pediatric drugs；Evaluation and approval system；Reform