摘要
目的:抑制虚假申报,提高药品注册审批效率。方法:通过建立药品注册管制者与被管制者间完全信息静态博弈模型,分析对虚假申报进行审批的影响因素。结果与结论:建立企业及政府责任追究机制有利于提高药品注册审批效率。应建立企业及政府责任追究机制,建立药害赔偿机制,健全药品不良反应监测报告机制。
OBJECTIVE： To prevent false declaration and to improve the efficiency of drug registration.METHODS： Static game model for connecting enterprise with government was established to analyze influence factors of approving false declaration.RESULTS CONCLUSIONS： The accountability system for enterprise and government is helpful to improve efficiency of drug registration.The accountability system,drug injury compensation system,ADR monitoring and reporting system should be set up.
出处
《中国药房》
CAS
CSCD
北大核心
2010年第21期1931-1933,共3页
China Pharmacy
关键词
药品注册
虚假申报
博弈论
Drug registration
False declaration
Game theory
