关键词: 美国, 上市后监测, 药品不良反应监测, 生产企业

Abstract: Objective By introducing the post marketing surveillance system in the United States, it provided advice on carrying out mainl responsibility of manufacturer. Methods Using literature review,it was showed the US surveillance system included general situation of the adverse event reporting, FDA adverse event reporting system(FAERS) and post marketing adverse drug experience(PADE) reporting inspection. Results FDA has set up advanced post marketing system including systemic legislation and effective investigation mechanism to make manufacturer perform mainl responsibility. Conclusion FDA provided the example and reference on requirements,scope,and inspection mechanism for carrying out reporting responsibility of manufacturers in China.

Key words: the United States, post marketing surveillance, adverse drug reaction monitoring, manufacture