Evolution of drug regulations and regulatory innovation for anticancer drugs in China

作     者：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 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 MedicineTsinghua UniversityBeijing 100084China Center for Drug EvaluationNational Medical Products AdministrationBeijing 100038China Pharmcube(Beijing)Co.Ltd.Beijing 100102China Department of Clinical PharmacyCancer Hospital of Fudan UniversityShanghai 200032China Vanke School of Public HealthTsinghua UniversityBeijing 100084China Shanghai Collaborative Innovation Center for Translational MedicineShanghai University of Traditional Chinese MedicineShanghai 201203China Office of Clinical Trial InstituteBeijing Tsinghua Changgung HospitalBeijing 102218China 

出 版 物：《Acta Pharmaceutica Sinica B》 (药学学报（英文版）)

年 卷 期：2022年第12卷第12期

页      面：4365-4377页

核心收录：

学科分类：1007[医学-药学(可授医学、理学学位)] 10[医学] 

主　　题：Regulatory innovations Drug R&D Anticancer drugs Innovative drugs Expedited program designations Drug lag Globalization Unmet medical need 

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 *** 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 *** drug development in China has boomed,benefiting in particular from pro-innovation policies as well as expedited program designations by the *** found a significant 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 *** lag has also been dramatically shortened by more than 70%for imported drugs in years 2016-2020 compared to years ***,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 *** 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 development in China and worldwide.