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Positive effect of review and approval system reform on clinical trials
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Na NI1, Ran-ran CUI2, Yan ZHENG2, hong-zhi DENG2, Bin ZHOU1
Chinese Journal of New Drugs | 2021, 30(20) : 1825 - 1829
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Chinese Journal of New Drugs | 2021, 30(20): 1825-1829
Positive effect of review and approval system reform on clinical trials
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Na NI1, Ran-ran CUI2, Yan ZHENG2, hong-zhi DENG2, Bin ZHOU1
Affiliations
  • 1Clinical Research Center, China State Institute of Pharmaceutical Industry, Shanghai 200437, China
  • 2Shanghai Clinical Research Organization for Medicines/InCROM China, Shanghai 200437, China
Published: 2021-10-30
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Since the publication of Opinions of the State Council on the Reform of Drug and Medical Device Review and Approval System in 2015, the original CFDA and the current NMPA carried out a series of reform on the review and approval system to make the clinical trials in China to meet the international levels and reduce the large number of reviews and approvals waiting in line, and China successfully joined the ICH in June 2017. The reform exerted some positive effects on clinical trial conducting in China, which were analyzed and reviewed in this article.

clinical trial  /  review and approval  /  reform of management and rules
倪娜, 崔然然, 郑岩, 邓红枝, 周斌. 审评审批管理制度改革对临床试验开展的促进作用. 中国新药杂志, 2021 , 30 (20) : 1825 -1829 .
Na NI, Ran-ran CUI, Yan ZHENG, hong-zhi DENG, Bin ZHOU. Positive effect of review and approval system reform on clinical trials[J]. Chinese Journal of New Drugs, 2021 , 30 (20) : 1825 -1829 .
Year 2021 volume 30 Issue 20
25
5
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  • Online Date:2026-10-30
  • Published:2021-10-30
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  • Accepted:2021-02-02
Affiliations
    1Clinical Research Center, China State Institute of Pharmaceutical Industry, Shanghai 200437, China
    2Shanghai Clinical Research Organization for Medicines/InCROM China, Shanghai 200437, China
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表12种不同金属材料的力学参数
科
Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)
属
Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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