Research and reflection on regulatory science developments of U.S. FDA

doi:10.19803/j.1672-8629.20220453

Abstract

Abstract: Objective To introduce the regulatory developments of U.S. Food and Drug Administration (FDA), so as to provide reference for the drug regulation in China. Methods New initiatives and their latest progress in FDA are introduced by translation and research on related regulations and documents, and the correlation to the reform of drug review and approval in China is analyzed. Results and Conclusion According to the drug regulation in China, it is suggested that experiences of drug regulation from FDA should be overviewed and classified into regulatory methods and regulatory tools, providing methodological reference to regulators, so as to improve the quality and efficiency of drug regulation, as well as the internationalization of regulatory capacities.

Key words: U.S. Food and Drug Administration (FDA), regulatory science, drug regulation, drug application, quality of the drug technical review

CLC Number:

R951
R994.11

SHA Mingquan, LI Nannan, XIA Wenjing, WEI Qun, WEN Baoshu. Research and reflection on regulatory science developments of U.S. FDA[J]. Chinese Journal of Pharmacovigilance, 2022, 19(10): 1055-1059.

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