To supply references for the establishment and improvement of China drug risk management system.Compared drug risk management practices in some different countries and regions,such as the U.S,EU,Britain,France,Japan,discuss the enlightenment of establishment and improvement of China drug risk management system in the views of essential elements: laws and regulations,organizations,monitoring,communication,resources and support. To establish and improve China drug risk management system should improve rules and regulations to establish its law system,promote the status of marketed drug evaluation department,set up multi-resource drug safety information database,enhance international communication to widen information medium,and conform communication mechanism of marketed drug safety information. <<