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

Acta Pharmaceutica Sinica B 2022年第12期12卷 4365-4377页

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 Tsinghua Clinical Research Institute(TCRI) School of MedicineTsinghua UniversityBeijing 100084China Center for Drug Evaluation National Medical Products AdministrationBeijing 100038China Pharmcube(Beijing)Co. Ltd.Beijing 100102China Department of Clinical Pharmacy Cancer Hospital of Fudan UniversityShanghai 200032China Vanke School of Public Health Tsinghua UniversityBeijing 100084China Shanghai Collaborative Innovation Center for Translational Medicine Shanghai University of Traditional Chinese MedicineShanghai 201203China Office of Clinical Trial Institute Beijing Tsinghua Changgung HospitalBeijing 102218China

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.

关键词： regulatory innovations Drug R&D Anticancer drugs Innovative drugs Expedited program designations Drug lag Globalization Unmet medical need

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