新医改下药品召回制度的建设

Drug recall system under the circumstances of new healthcare reform

药品召回(Drug Recall)是一种国际通行的制度,当药品经应用后发现存在严重缺陷或即使正确使用也可能出现严重安全隐患时,生产企业和经销商有责任对该药品撤回或改正。在召回制度成熟的国家,药品召回的程序、监督和赔偿等均有明确的规定。中国目前的药品召回工作尚处于起步阶段,具体实施缺乏必要的经验和法律依据,这种制度上的滞后,不仅影响国际间的交流,还会影响消费者的切身利益,给公众健康带来危险隐患。因此,建立完善的药品召回制度,为新型合作医疗提供支持,是十分重要的和必须的。

Drug Recall is an internationally accepted system that,when the drug was found of serious shortcomings during application or even proper usage may also cause serious security risks,the manufacturers and dealers have the responsibility of the drug withdrawn or correction.In countries with mature drug recall system,drug recall procedures,supervision and compensation are clearly stipulated.China＇s current drug recall system is still at the initial stage,lacking necessary experience and legal basis to concretely execute the system,and such a system lag not only affects international exchange,but also influences the immediate interests of consumers and threats public health.Therefore,to establish a sound drug recall system and provide support for new cooperative medical care is extremely important and necessary.