构建中国特色药品召回制度

On the Construction of Drug Recall System with Chinese Characteristics

药品召回是一项复杂的系统工程,实施者、协调者和监管者等在药品召回过程中各自发挥着独特的作用。药品"同质"现象普遍、药品不良反应监测体系不完善、药品监管部门责任不明等制约着各行为主体在药品召回过程中作用的发展。应从加强药品研发知识产权保护、推动企业建设药品不良反应监测体系、明确政府监管职责等方面努力,构建中国特色的药品召回制度。

Drug Recall is complex system engineering. Implementers, coordinators and regulators play unique roles in the process of clrug recalls. There are several reasons restrict the function of various actors in the process of drug recalls, for example, drug ＂homogeneous＂ is widespread, adverse drug reaction monitoring system is imperfect, and the responsibility of the drug regulatory authorities is not clear. The government should strengthen the pharma- ceutical R ＆ D and intellectual property protection, promote enterprises to build Adverse Drug Reaction Monitoring system and define government regulatory responsibilities in order to build drug recall system with Chinese character- istics.