Abstract: New policies on drug regulation have been issued in China in recent years, including encouraging R & D of pediatric drugs. We analyzed 80 drug registration applications for pediatric drugs included in the priority review and approval list, and found that drugs from outside China's mainland and orphan drugs accounted for a certain proportion. Based on the data analysis results by Pharmaprojects^®, Biomedtracker^® and Medtrack^® of Informa, three strategies for the research and development of pediatric drugs are proposed, so as to provide reference for related pharmaceutical enterprises, with much attention to the newly marketed pediatric drugs outside China's mainland, the development of drugs against rare diseases, and cooperating with teams holding key development technologies for pediatric drug formulation.