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

摘要/Abstract

摘要： 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.

关键词: FDA, real-world data, real-world evidence, enlightenment

Abstract: 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.

Key words: FDA, real-world data, real-world evidence, enlightenment

Yu Xiuna, Li Wanying, Dong Li. The Enlightenment of FDA’s “Real-World Evidence Program Framework” to China[J]. 亚洲社会药学, 2021, 16(3): 225-229.

Yu Xiuna, Li Wanying, Dong Li. The Enlightenment of FDA’s “Real-World Evidence Program Framework” to China[J]. Asian Journal of Social Pharmacy, 2021, 16(3): 225-229.

[1]	Shang Ya’nan, Huang Zhe. Application of Real-World Evidence in the Approval of Antitumor Drugs[J]. 亚洲社会药学, 2024, 19(4): 311-318.
[2]	Gong Jingyu, Tian Lijuan. Analysis of Innovations in Monitoring Adverse Drug Reaction and Application[J]. 亚洲社会药学, 2024, 19(4): 319-326.
[3]	Xiao Feiyi, Zhang Fang, Li Xue, Dong Li. Current Situation and Prospect of the Application of Real-World Evidence in Health Care[J]. 亚洲社会药学, 2023, 18(4): 374-386.
[4]	Chang Senhao, Chang Yingnan, Gong Jingran, Chen Yuwen. Analysis and Enlightenment of Big Data Platform for Adverse Drug Reaction Supervision in China and the United States [J]. 亚洲社会药学, 2023, 18(3): 213-220.
[5]	Jiang Yang, Yang Yue. Study on the Changes of FDA Finished Pharmaceuticals Warning Letters between 2011 and 2021 [J]. 亚洲社会药学, 2022, 17(4): 291-299.
[6]	Xie Xuerong, Tian Lijuan. The Latest Advance of the FDA Sentinel Initiative and Its Enlightenment to China[J]. 亚洲社会药学, 2022, 17(2): 95-103.
[7]	Li Yanying , Huang Zhe, Lian Guiyu. Drug Regulatory Science in EU and Its Enlightenment to China[J]. 亚洲社会药学, 2022, 17(2): 115-119.
[8]	Ma Jia, Li Xiaoqi, Raela·Abduhilil, Sun Lihua. Management of Orphan Drug Reimbursement Abroad and Its Enlightenment to China[J]. 亚洲社会药学, 2021, 16(4): 352-357.
[9]	Yang Lingling, Xu Fengxiang. EU Real-World Evidence Supports New Drug Research and Development Decisions and Its Implications for China[J]. 亚洲社会药学, 2021, 16(3): 197-202.
[10]	Lan Yipeng, Huang Zhe. Real-World Evidence Supporting New Drug Review and Approval in European Union and Its Enlightenment to China[J]. 亚洲社会药学, 2021, 16(3): 203-208.
[11]	Yu Zhongyi, Xu Fengxiang. The Enlightenment of EU Real-World Evidence Supporting the Inclusion of Rare Disease Drugs in Medical Insurance Decisions to China[J]. 亚洲社会药学, 2021, 16(3): 209-213.
[12]	Wang JiaoJiao, Huang Zhe. EU Real-World Evidence Supports the Expansion Indications for Drugs and Its Enlightenment to China[J]. 亚洲社会药学, 2021, 16(3): 214-218.
[13]	Wang Chao, Lian Guiyu. Research on Real-World Evidence and Application in EU and Its Enlightment to China[J]. 亚洲社会药学, 2021, 16(3): 219-224.
[14]	Huang Xianqin, Chen Chuhan, Dong Li. Application of Real-World Evidence in Regulatory Decision-Making for Medical Devices[J]. 亚洲社会药学, 2021, 16(3): 230-237.
[15]	Li Longxiao, Lian Guiyu. How Real-World Evidence Supports Healthcare Decisions in EU and Its Enlightment to China[J]. 亚洲社会药学, 2021, 16(3): 238-241.

亚洲社会药学