The effects of Urgently Needed Overseas Drugs on the launch delay of new drugs in China  

作　　者：Xingyue Zhu Yang Chen 

机构地区：[1]Department of Pharmacy Administration,School of Medicine and Health Management,Guizhou Medical University,Guiyang,550025,China [2]Center of Medicine Economics and Management Research,Guizhou Medical University,Guiyang,550025,China [3]Department of Hospital Quality Evaluation and Medical Record Management,the Third People's Hospitalof Chengdu,Chengdu,610014,China

出　　处：《Pharmacoeconomics and Policy》2025年第1期15-20,共6页药物经济与政策(英文)

摘　　要：The Chinese drug agency has issued the Urgently Needed Overseas Drug(UNOD)lists since 2018,which allows drugs to be approved based on overseas trial data,to address drug delays.We aimed to evaluate the effects of the UNOD on the drug launch delay in China.We collected the new molecular entities and biologics approved in the United States from 2012 to 2019,and measured the launch delay of these drugs in China.An instrumental variables(IV)strategy of the causal exposure effect in Cox model was established to examine the effects of the UNOD on the time from the approval in the United States to the approval in China.A total of 278 new drugs were approved in the United States from 2012 to 2019,of which 15.1%were designated as UNOD by the Chinese drug agency.Among all the drugs,only 34.9%reached the Chinese market before July 1,2024,with a mean of launch delay of 2397.2 days(standard deviation(SD)=1037.0).The IV estimator found that,after accounting for the endogeneity concerns,the UNOD did not have a significant effect on the launch delay(coefficient=-2.52 and robust standard error=1.73).The main reason may be that there are other policies delivering similar benefits to non-UNOD drugs,which undermines the priority of the UNOD-designated drugs in the drug approval process.The UNOD designation did not attract more applications for the urgently needed oversea drugs.Our findings highlight the need of prioritizing the drugs with substantial clinical benefits in the drug regulatory process.

关 键 词：Drug lag Launch delay Drug access Instrumental variables 

分 类 号：O17[理学—数学]