Introduction to FDA's disclosure of compliance inspection information of research and development entities of drug clinical trials and its implication for China
LIU Yi-di
HE Hui
ZHOU Gang
Abstract：The Food and Drug Administration(FDA)of the United States has mature experience in the disclosure of compliance inspection information and database construction for research and development entities of drug clinical trials.This article provides a systematic introduction to this system of FDA.Based on the current regulatory status in China,suggestions were proposed for the drug regulatory authorities to establish a standardized compliance inspection information database and improve the accessibility of compliance inspection information of research and development entities of drug clinical trials.
Keywords：drug clinical trialcompliance inspectionclinical investigatordrug clinical institute
Publication Date：2024-01-31
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：7( 124-130 )