典型文献
Evolution of drug regulations and regulatory innovation for anticancer drugs in China
文献摘要：
Over the past two decades,China has introduced significant changes to drug regulations through regulatory innovations to accelerate drug review and approvals,keeping in line with the rapidly growing scientific innovation in drug research and development(R&D).In this study,we outlined the revolution of drug regulation in China since the establishment of the State Drug Administration in 1998.More particularly,we performed a comprehensive analysis of newly approved anticancer drugs in China from the year 2005 to May 2021,as a powerful illustration of how the revolution has changed the drug R&D landscape.Innovative drug development in China has boomed,benefiting in particular from pro-innovation policies as well as expedited program designations by the authority.We found a sig-nificant increase in the number of both imported and domestic new anticancer drugs from 2005 to 2021,with the emergence of drugs with novel mechanisms of action,including immune checkpoint inhibitors and cell therapy products.Drug lag has also been dramatically shortened by more than 70％for imported drugs in years 2016-2020 compared to years 2006-2010.Furthermore,we provide an insight into the potential approaches to further optimize the science-based and clinical value-based regulatory and R&D drug ecosystem in China.This review provides evidence of significant impacts of regulations and policies on drug R&D and suggests that the constantly adapting regulatory ecosystem will speed up drug devel-opment in China and worldwide.
文献关键词：
中图分类号：
作者姓名：
Yang Liu;Ning Zhang;Cuicui Xie;Yale Jiang;Yunhe Qin;Liyun Zhou;Yi Fan;Lianjie Ren;Chen Yin;Huan Yang;Wei Xie;Qing Zhai;Guanqiao Li;Hongzhuan Chen;Xiaoyuan Chen
作者机构：
Tsinghua Clinical Research Institute(TCRI),School of Medicine,Tsinghua University,Beijing 100084,China;Center for Drug Evaluation,National Medical Products Administration,Beijing 100038,China;Pharmcube(Beijing)Co.,Ltd.,Beijing 100102,China;Department of Clinical Pharmacy,Cancer Hospital of Fudan University,Shanghai 200032,China;Vanke School of Public Health,Tsinghua University,Beijing 100084,China;Shanghai Collaborative Innovation Center for Translational Medicine,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;Office of Clinical Trial Institute,Beijing Tsinghua Changgung Hospital,Beijing 102218,China
文献出处：
引用格式：
[1]Yang Liu;Ning Zhang;Cuicui Xie;Yale Jiang;Yunhe Qin;Liyun Zhou;Yi Fan;Lianjie Ren;Chen Yin;Huan Yang;Wei Xie;Qing Zhai;Guanqiao Li;Hongzhuan Chen;Xiaoyuan Chen-.Evolution of drug regulations and regulatory innovation for anticancer drugs in China)[J].药学学报（英文版）,2022(12):4365-4377
A类：
boomed,designations
B类：
Evolution,regulations,regulatory,anticancer,drugs,China,Over,past,two,decades,has,introduced,significant,changes,through,innovations,accelerate,review,approvals,keeping,rapidly,growing,scientific,research,development,this,study,outlined,revolution,since,establishment,State,Drug,Administration,More,particularly,performed,comprehensive,analysis,newly,approved,from,May,powerful,illustration,how,changed,landscape,Innovative,benefiting,policies,well,expedited,program,by,authority,We,found,increase,number,both,imported,domestic,emergence,novel,mechanisms,action,including,immune,checkpoint,inhibitors,cell,therapy,products,lag,also,been,dramatically,shortened,than,years,compared,Furthermore,insight,into,potential,approaches,further,optimize,science,clinical,value,ecosystem,This,provides,evidence,impacts,suggests,that,constantly,adapting,will,speed,up,worldwide
AB值：
0.532683
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