我国药品质量规制失灵原因分析  

Reasons of drug quality regulation malfunctions in China

作　　者：颜建周[1] 杨彬[1] 邵蓉[1] 

机构地区：[1]中国药科大学国家药物政策与医药产业经济研究中心,南京211198

出　　处：《中国新药杂志》2015年第19期2175-2178,共4页Chinese Journal of New Drugs

基　　金：国家社会科学基金一般项目<药品质量规制视角下的药品监管法实施效果研究>(11BFX098);中国药科大学医药产业发展研究中心社会科学研究基金(CPUSJ1308)

摘　　要：分析我国药品质量规制失灵的原因并提出政策建议。运用规制理论的分析方法,并构建药监部门、企业之间的行为博弈模型。对生产过程监管的轻视、企业违法成本低、药监部门规制成本高、药监失责责任追究体系不健全是我国药品质量规制失灵的主要原因。药监部门应当加强药品生产过程监管、加大对违法处罚力度,降低质量规制成本,健全渎职失责的责任追究。The reasons of drug quality regulation malfunctions in China were analyzed in this article. Using the theories of regulation,a game model was used to analyze the behaviors between drug administrations and manufactures. The main reasons of drug quality regulation malfunctions include that the drug administrations did not pay enough attention to regulating drug manufacturing process,the penalties for illegal enterprise were low,the regulation costs were too high and the responsibility system of malfeasance was imperfect. The drug manufacturing process supervision should be strengthened,the penalties for illegal enterprise should be increased,the cost of the drug quality regulation should be reduced,and the responsibility system of malfeasance should be improved.

关 键 词：药品质量规制 规制失灵 博弈分析 

分 类 号：R95[医药卫生—药学]