2011—2021年中国新药批准上市滞后问题探讨  

Discussion on the drug lag issue in the approval of new drugs in China between 2011 and 2021

作　　者：吴闻雨 吴亦凡 陈雪莹 陈子婷 刘佐仁 WU Wen-yu;WU Yi-fan;CHEN Xue-ying;CHEN Zi-ting;LIU Zuo-ren(School of Pharmacy,Guangdong Pharmaceutical University,Guangzhou 510006,China;Institute of Pharmaceutical Regulatory Science,School of Pharmacy,Tsinghua University,Beijing 100084,China;Key Laboratory for Technology Research and Evaluation of Pharmacovigilance,National Medical Products Administration,Guangzhou 510006,China)

机构地区：[1]广东药科大学药学院,广州510006 [2]清华大学药学院药品监管科学研究院,北京100084 [3]国家药品监督管理局药物警戒技术研究与评价重点实验室,广州510006

出　　处：《中国新药杂志》2023年第11期1073-1082,共10页Chinese Journal of New Drugs

基　　金：广东省药品监督管理局科技创新项目:重大卫生安全事件应急药品供应监测保障机制研究(2021TDZ11)。

摘　　要：目的:分析2011—2021年期间中国获批新药上市的绝对滞后与相对滞后的状况及原因,并初步探究影响新药上市滞后的潜在因素。方法:收集2011—2021年期间中国、美国、欧盟以及日本药监部门批准上市的新药信息,并确定中国批准上市的新药在全球首次获批上市的时间,以计算中国新药上市的绝对滞后和相对滞后;采用多元回归分析方法探究药物滞后相关的影响因素。结果:2011—2021年期间中国共批准新药280个,与美国、欧盟和日本的绝对滞后分别为180,82和154个。总体相对滞后中位时长为1 359 d,其中2011—2014年滞后中位时长逐渐增加,2014年达到顶峰(3 438 d);2015—2018年滞后中位时长下降明显;2019—2021年滞后中位时长呈逐年下降态势,2020和2021年处于总体滞后中位时长以下,分别为1 134和500 d。感觉器官治疗领域[非标准化系数(B)=-1 153.840,P<0.05]的新药与较短的滞后中位时长相关,具有孤儿药认定资格(B=441.147,P<0.01)、分类为生物制品(B=502.205,P<0.01)的新药与较长的滞后中位时长相关。结论:2011—2021年中国新药上市滞后问题得到明显的改善,但各治疗领域的新药仍普遍存在滞后现象。在新政策背景下,进一步提升新药审评审批的质量和效率、加强政府审批机构与申报企业的沟通交流、对接国际通行规则、鼓励企业开展国际多中心临床试验等是减少新药上市滞后的关键。Objective:To analyze the absolute lag and relative lag time of new drug approvals in China from 2011 to 2021 and reasons causing the lag,and to preliminarily explore the potential factors that affect the new drug launch lag.Methods:The information on new drugs approved for marketing in China,the United States,the European Union and Japan was collected from 2011 to 2021.The durations between the time when the new drugs approved for marketing in China were first approved for marketing in the world were calculated to analyze absolute lag and relative lag in China.Multiple regression analysis was used to determine the factors related to drug lag.Results:During the period from 2011 to 2021,a total of 280 new drugs were approved in China,among which 180,82 and 154 drugs exist absolute lags with the United States,the European Union and Japan,respectively.The median duration of the overall relative lag was 1359 days.The median length of the lag gradually increased from 2011 to 2014,and reached a peak(3438 days)in 2014;the median length dropped significantly from 2015 to 2018;the median length in 2019 to 2021 decreased year by year.The overall lag in 2020 and 2021 were below the overall median lag,1134 days and 500 days respectively(B=-1153.840,P<0.05).New drugs in theraprutic area of sensory organs were related to a shorter median approval lag,and new drugs of orphan drug designation(B=441.147,P<0.01)and classified as biological products(B=502.205,P<0.01)were related to a longer median approval lag.Conclusion:In the past years of 2011-2021,the drug lag issue in China has been significantly improved,but the lag phenomenon still exists in new drugs in various therapeutic fields.Under the background of the new policy implement,key factors to reduce the delay in the launch of new drugs include further improving the quality and efficiency of new drug review and approval,strengthening the communication between government approval agencies and applying companies,connecting with international common rules,and encouraging compani

关 键 词：上市滞后 新药审评审批 滞后因素 

分 类 号：R95[医药卫生—药学]