OBJECTIVE： To provide reference for perfecting the legal liability setting for drug safety in China. METHODS： By literature study analysis， the characteristics of legal liability in the United States were reviewed comprehensively in respects of drug clinical research， listing application， production， marketing， advertising， post-marketing surveillance， recall， etc. Based on this， some suggestions were put forward for setting up the legal liability for drug safety in China. RESULTS & CONCLUSIONS： The liability setting for drug safety in the United States has the following characteristics as clear and reasonable liability， strict punishment mechanism，flexible and efficient administrative sanctions，and incentive mechanism of encouraging honesty and self-discipline. Our country should learn from the advanced experience of drug legislation in the United States based on domestic practice. It is necessary to increase penalties for illegal activities，further improve the cohesion mechanism of administrative law enforcement and criminal justice，specify categories of illegal drugs and the legal liability，and establish a reasonable incentive mechanism， in order to improve drug safety legal liability setting， strengthen drug safety regulation and achieve the goal of ensuring public health and drug safety.