The changing landscape of clinical trial and approval processes in China

被引:0
|
作者
Qing Zhou
Xiao-Yuan Chen
Zhi-Min Yang
Yi-Long Wu
机构
[1] Qing Zhou and Yi-Long Wu are at the Guangdong Lung Cancer Institute,
[2] Guangdong General Hospital and Guangdong Academy of Medical Sciences,undefined
[3] 106 Zhongshan Er Road,undefined
[4] Guangzhou 510080,undefined
[5] China.,undefined
[6] Xiao-Yuan Chen and Zhi-Min Yang are at the Center for Drug Evaluation (CDE),undefined
[7] China Food and Drug Administration (CFDA),undefined
[8] 26 Xuanwumen Xidajie,undefined
[9] Beijing 100053,undefined
[10] China.,undefined
来源
关键词
D O I
暂无
中图分类号
学科分类号
摘要
The expansion of research and development of anticancer drugs in China has resulted in considerable delays in the approval of both clinical trials of novel agents, and the marketing approval of these agents once tested. In this Perspective, the authors describe the measures taken by the Chinese FDA to address these challenges in a rapidly developing research environment.
引用
收藏
页码:577 / 583
页数:6
相关论文
共 50 条
  • [41] Changing views in Canadian geomorphology: are we seeing the landscape for the processes?
    Walker, Ian J.
    [J]. CANADIAN GEOGRAPHER-GEOGRAPHE CANADIEN, 2010, 54 (03): : 261 - 276
  • [42] Materials and Processes for Medical Devices: How to Navigate the Changing Landscape
    不详
    [J]. ADVANCED MATERIALS & PROCESSES, 2011, 169 (07): : 32 - 33
  • [43] The changing political landscape in Sweden Political cleavages, actors and processes
    Elgenius, Gabriella
    Wennerhag, Magnus
    [J]. SOCIOLOGISK FORSKNING, 2018, 55 (2-3) : 139 - 154
  • [44] The Clinical Trial Landscape for Melanoma Therapies
    Wrobel, Sonia
    Przybylo, Malgorzata
    Stepien, Ewa
    [J]. JOURNAL OF CLINICAL MEDICINE, 2019, 8 (03)
  • [45] Alpelisib Is Changing the Clinical Landscape in Breast Cancer Treatment
    Saleh, Naveed
    [J]. ONCOLOGY-NEW YORK, 2019, 33 (11): : 434 - +
  • [46] The Changing Landscape of Randomized Clinical Trials in Cardiovascular Disease
    Jones, W. Schuyler
    Roe, Matthew T.
    Antman, Elliott M.
    Pletcher, Mark J.
    Harrington, Robert A.
    Rothman, Russell L.
    Oetgen, William J.
    Rao, Sunil V.
    Krucoff, Mitchell W.
    Curtis, Lesley H.
    Hernandez, Adrian F.
    Masoudi, Frederick A.
    [J]. JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2016, 68 (17) : 1898 - 1907
  • [47] Navigating complex clinical conversations in the changing landscape of immunotherapy
    Martin, Peter
    [J]. ASIA-PACIFIC JOURNAL OF CLINICAL ONCOLOGY, 2021, 17 : 91 - 91
  • [48] Sparta receives approval for clinical trial of 5-fluoropyrmidinone
    不详
    [J]. BIOTECHNOLOGY LAW REPORT, 1996, 15 (04): : 590 - 590
  • [49] Clinical trial designs for the approval of rare cancer drugs in Japan
    Noguchi, E.
    Yonemori, K.
    Shimoi, T.
    Yunokawa, M.
    Okuma, H. S.
    Kawachi, A.
    Kitano, A.
    Nishikawa, T.
    Shimomura, A.
    Shimizu, C.
    Takiguchi, Y.
    Kawai, A.
    Fujiwara, Y.
    Tamura, K.
    [J]. ANNALS OF ONCOLOGY, 2016, 27
  • [50] Large Clinical Trial Supports Alzheimer Drug Full Approval
    Wechsler, Jill
    [J]. BIOPHARM INTERNATIONAL, 2023, 36 (08) : 9 - 9