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The enlightenment to the establishment of real-world data applicability evaluation standard in China from “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices” of US FDA
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Xiao-liang YUAN1, 2, Li DONG1, 2, Ling-quan MENG1, 2, Yu-wen CHEN1, 2, Zhe HUANG1, 2
Chinese Journal of New Drugs | 2021, 30(11) : 976 - 979
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Chinese Journal of New Drugs | 2021, 30(11): 976-979
The enlightenment to the establishment of real-world data applicability evaluation standard in China from “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices” of US FDA
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Xiao-liang YUAN1, 2, Li DONG1, 2, Ling-quan MENG1, 2, Yu-wen CHEN1, 2, Zhe HUANG1, 2
Affiliations
  • 1Shenyang Pharmaceutical University School of Business Administration, Shenyang 110016, China
  • 2Shenyang Pharmaceutical University Shenyang Pharmaceutical University/Institute of Pharmaceutical Regulatory Sciences, Shenyang 110016, China
Published: 2021-06-15
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This paper is expected to provide reference for China to establish appropriate standards to evaluate the adaptability of real-world data, and facilitate the establishment of related systems for medical device approval and supervision. Finding appraised standard to evaluate the suitability of real-world data by analyzing the series of factors in the “Use of Real-world Evidence to Support Regulatory Decision-Making for Medical Devices”, in order to turn real-world data (RWD) into a truly practical real-word evidence (RWE). The adaptability assessment of China's RWD can be carried out from 2 aspects such as relevance and reliability. In the aspect of RWD relevance assessment, evaluation criteria can be designed from 5 aspects: data source and selection, data validity, regulatory requirements, ethical issues as well as operability. In the aspect of real world data reliability assessment, evaluation criteria can be designed from 3 aspects: management process standardization, data standardization and quality control.

real-world data  /  medical devices  /  regulatory decision-making  /  applicability evaluation standard
袁小量, 董丽, 孟令全, 陈玉文, 黄哲. 美国FDA《使用真实世界证据支持医疗器械的监管决策指南》对我国真实世界数据适用性评估标准建立的启示. 中国新药杂志, 2021 , 30 (11) : 976 -979 .
Xiao-liang YUAN, Li DONG, Ling-quan MENG, Yu-wen CHEN, Zhe HUANG. The enlightenment to the establishment of real-world data applicability evaluation standard in China from “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices” of US FDA[J]. Chinese Journal of New Drugs, 2021 , 30 (11) : 976 -979 .
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Year 2021 volume 30 Issue 11
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  • Online Date：2026-10-28
  • Published：2021-06-15
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  • Accepted：2020-10-21
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Affiliations
    1Shenyang Pharmaceutical University School of Business Administration, Shenyang 110016, China
    2Shenyang Pharmaceutical University Shenyang Pharmaceutical University/Institute of Pharmaceutical Regulatory Sciences, Shenyang 110016, China
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红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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