To analyze the current status of pediatric drug clinical trials in China so as to provide reference for its improvement.

Information about pediatric drug clinical trials was collected from the clinical trials explicitly labeled of CDE. The clinical trial type, clinical trial stage, recruitment, insurance and DMC were analyzed statistically by ratio analysis method.

By June 2020, 10 933 clinical trials had been registered on the platform, including 139 pediatric drugs. Among these pediatric drug clinical trials, phase Ⅲ clinical trials had the largest number. In aspect of drug classes, biological products had the largest number of clinical trials, followed by chemical drugs, while traditional Chinese medicine had the least registration number. In addition, the enthusiasm of children's drug companies in China for new drug research and development is not high. There are some problems in pediatric drug clinical trials, such as the long trial period and difficult recruitment of subjects.