欧盟儿科用药政策对我国儿科用药管理的启示

Enlightenment of the European Union Pediatric drug policy on the menagement of pediatric drugs in China

儿童健康事关民族未来,随着全面二孩政策的放开,儿科用药需求持续增长,儿童专用药品、剂型缺乏的问题日益凸显,儿科用药保障面临新的挑战。儿科用药保障需要有坚实的立法为基础,完善的法规、规章制度作支撑确保儿童用药权益。欧盟颁布《儿科用药管理条例》至今已有十余年立法经验,并在注册审批、临床试验等方面取得明显成效。我国可借鉴欧盟立法经验,进一步完善我国儿科用药相关政策。

Children’s health is very important for the national future.With the liberalization of the universal two-child policy,the demand for pediatric medicines continues to grow.The problem of child-specific medicines and dosage forms shortage has been increasingly prominent,which poses a new challenges to the guarantee of pediatric medicines.Pediatric medication protection needs to be based on solid legislation and supported by perfect laws and regulations to ensure children’s medication rights and interests.It has been more than ten years of legislative experience since European Union promulgate Paediatric Regulation,and it has remarkable achievement in registration,approval,clinical trials and other aspects.China can learn from the experience of European Union legislation to further improve the policy of pediatric medication.