OBJECTIVE： To provide reference for promoting the development of related legislation work on ensuring pediatric drug use in China. METHODS： The legislation process of pediatric drug use in US， the effects of current Best Pharmaceuticals for Children Act and Pediatric Research Equity Act on pediatric drug use in US were intrduced and analyzed， suggestions on guaranteeing the accessibility and safety on pediatric drug use in China were put forward. RESULTS & CONCLUSIONS： The policy “6-month period of pediatric exclusive protection” in Best Pharmaceuticals for Children Act has motivated the enthusiasm of pharmaceutical companies developing pediatric studies， while it affects the marketing of generic drugs. Pediatric Research Equity Act has achieved remarkable effect in terms of ensuring the safety of pediatric drug use by forcing pharmaceutical companies to carry out pediatrics assessments， while there is no enough force for the marketed drugs that has not been widely used for children. Encouragement and enforcement are useful methods for promoting development of pediatric drug use. It is suggested to take measures like modifing “one drug two forms” in Prescription Management Regulations， accelerating approvals of related pediatric drugs on the premise that safety is guaranteed， implementing tax preference for related pharmaceutical companies that produced pediatric drugs， promoting the entry of drug reimbursement list and empowering CFDA to force pharmaceutical companies to implement pediatric studies to promote the accessibility and safety of pediatric drugs.