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US FDA “Real-World Evidence Program”: the enlightenment to China
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Li DONG1, 2, Gui-yu LIAN1, 2, Chuang WANG1, 2, Xian-qin HUANG1, Yu-wen CHEN1, 2, Zhe HUANG1, 2
Chinese Journal of New Drugs | 2021, 30(11) : 980 - 983
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Chinese Journal of New Drugs | 2021, 30(11): 980-983
US FDA “Real-World Evidence Program”: the enlightenment to China
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Li DONG1, 2, Gui-yu LIAN1, 2, Chuang WANG1, 2, Xian-qin HUANG1, Yu-wen CHEN1, 2, Zhe HUANG1, 2
Affiliations
  • 1Shenyang Pharmaceutical University School of Business Administration, Shenyang 110016, China
  • 2Shenyang Pharmaceutical University Institute of Pharmaceutical Regulatory Science, Shenyang 110016, China
Published: 2021-06-15
Outline
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This article aims to provide reference for China to use real-world evidence (RWE) in drug approval and regulatory decision-making system. The main content of “Real-World Evidence Program” issued by US FDA was summarized by literature research method, and the construction of related systems in China were analyzed. To promote the application of real-world research for drug regulatory decisions, China should publish guidelines related to real-world research, promote the construction of data standards and shared database, extensively introduce the demonstration projects as well as strengthen the guidance for real-world research of enterprises. And at the same time, the relationship between stakeholders should be paid attention to deal with.

US FDA  /  real-world data  /  real-world evidence  /  enlightenment
董丽, 连桂玉, 王闯, 黄先琴, 陈玉文, 黄哲. 美国FDA《真实世界证据计划框架》及对我国的启示. 中国新药杂志, 2021 , 30 (11) : 980 -983 .
Li DONG, Gui-yu LIAN, Chuang WANG, Xian-qin HUANG, Yu-wen CHEN, Zhe HUANG. US FDA “Real-World Evidence Program”: the enlightenment to China[J]. Chinese Journal of New Drugs, 2021 , 30 (11) : 980 -983 .
Year 2021 volume 30 Issue 11
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  • Online Date:2026-10-28
  • Published:2021-06-15
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  • Accepted:2020-10-29
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    1Shenyang Pharmaceutical University School of Business Administration, Shenyang 110016, China
    2Shenyang Pharmaceutical University Institute of Pharmaceutical Regulatory Science, Shenyang 110016, 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
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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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