中美专利药加快审评模式比较研究——基于创新药物条件审批制度的实证分析  

Comparison of the expedited programs of patent drugs in China and America based on the empirical analysis of conditional approval systems for innovative drugs

作　　者：丁锦希[1] 李鹏辉[1] 姚雪芳[1] DING Jin-xi LI Peng-hui YAO Xue-fang(China Pharmaceutical University, Nanjing 211198, China)

机构地区：[1]中国药科大学,南京211198

出　　处：《中国新药杂志》2016年第24期2807-2813,共7页Chinese Journal of New Drugs

基　　金：国家社会科学基金资助项目(13BFX120);国家食品药品监督管理总局药品审评中心2014年委托课题<国外药品注册审评法规科学和评价策略研究>;国家食品药品监督管理总局2016年委托课题<新形势下药品数据保护与专利链接制度评估与设计>的阶段性成果

摘　　要：目的:比较研究中美条件审批模式,为我国完善制度设置,为提高疗效显著专利药的可获得性提供借鉴建议。方法:对比分析美国和中国制度内容及实施绩效,提出针对性的完善建议。结果:条件审批模式可显著加快新药研发进程,提高专利药可获得性,与美国相比我国制度设置仍有诸多不足。结论:建议我国借鉴美国经验,全面完善条件审批模式各项制度内容,强化对突破性创新专利药的扶持力度,提高其临床可获得性。Objective： To compare the conditional approval systems between the U. S. and China in order to provide suggestions to China＇s system setting and improve availability of patent drugs with breakthrough effect.Methods： The contents and implementation performance of conditional approval systems in the U. S. and China were contrastively analyzed,and suggestions for China＇s system improvement were proposed after that. Results：The conditional approval system could markedly accelerate the research process of patent drugs and improve its availability. Compared with the U. S.,there are still many deficiencies in China＇s system. Conclusion： It is necessary to reform the conditional approval system in China,strengthen the guidance for patent drugs with breakthrough efficacy,and improve its availability with reference to American practice.

关 键 词：专利药 条件审批模式 中美比较 

分 类 号：R95[医药卫生—药学]