药品上市后监察是药品管理工作的一个重要内容。为了保障人民用药安全,许多国家建立了药品上市后监察制度。美国对处方药的上市后监察制度比较科学、合理,许多地方值得我们学习、参考。 一、一般情况 人们对药品上市后监察工作的重要性有个认识过程。1927年美国不少人服用抗感染药磺胺酏剂,有300多人发生中毒,死亡100多人。 Post-market surveillance is an important part of drug management. In order to ensure people’s drug safety, many countries have set up post-marketing supervision system. The post-market surveillance system for prescription drugs in the United States is comparatively scientific and reasonable and many places deserve our study and reference. First, the general situation People on the market after the monitoring of the importance of having a cognitive process. In 1927, many people in the United States took the anti-infective drug sulfonamide elixir and poisoned more than 300 people, killing more than 100 people.