The Enlightenment of FDA’s“Real-World Evidence Program Framework”to China

Yu Xiuna; Li Wanying; Dong Li

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The Enlightenment of FDA’s“Real-World Evidence Program Framework”to China

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Objective To provide a reference for China to use real-world evidence(RWE)in drug approval and regulatory decision-making system.Methods The main content of“Real-World Evidence Program Framework”issued by the FDA was summarized by literature research method,and the related system construction in China was analyzed.Results and Conclusion To promote the use of real-world study(RWS)for drug regulatory decisions,China should issue guidelines on RWS.Besides,the construction of data standards and the shared database should be strengthened.Then,the demonstration projects should be introduced extensively and the guidance for RWS of enterprises must be enhanced.Meanwhile,close attention should be paid to dealing with the relationship between stakeholders.

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来源
《亚洲社会药学》 |2021年第3期|P.225-229|共5页
作者
Yu Xiuna; Li Wanying; Dong Li;
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作者单位

School of Business Administration Shenyang Pharmaceutical University Shenyang 110016 China;

School of Business Administration Shenyang Pharmaceutical University Shenyang 110016 China;

School of Business Administration Shenyang Pharmaceutical University Shenyang 110016 China;

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原文格式 PDF
正文语种 chi
中图分类中国工业经济;
关键词
FDA; real-world data; real-world evidence; enlightenment;

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4. EU Real-World Evidence Supports the Expansion Indications for Drugs and Its Enlightenment to China [J] . Wang JiaoJiao ,Huang Zhe . 亚洲社会药学 . 2021,第003期
5. Research of FDA Risk-Based Drug Inspection Program and Its Enlightenment [J] . Yang Luyao ,Dong Jiangping ,Yang Yue . 亚洲社会药学 . 2021,第002期
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The Enlightenment of FDA’s“Real-World Evidence Program Framework”to China

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