New considerations for the risk-based initiation of drug registration clinical trial inspection from the perspective of regulatory science
HE Hui
LIU Yi-di
ZHOU Gang
Abstract：In order to make reasonable use of regulatory resources for drug registration inspection and strengthen the regulation of drug research and development process,China's drug regulatory authorities have established a"risk-based"and"technical-review-based"drug registration inspection initiation model based on the current status of China's pharmaceutical industry and in reference to foreign drug regulatory practices,which has improved the pertinence and effectiveness of registration inspection and optimized China's drug registration regulatory system.Furthermore,to some extent,it has promoted the high-quality development of the pharmaceutical industry.However,in the exploration of regulatory practice,there are still issues such as insufficient identification of risk factors and insufficient in-depth consideration for risk model construction.This article analyzed the working modes of China and foreign drug regulatory agencies in initiating inspections of drug registration clinical trials and proposed several suggestions for optimizing the initiation of inspections of drug registration clinical trials based on the current situation and experience of regulatory work in China.
Keywords：drug registration inspectionrisk factorsdrug regulation
Publication Date：2024-04-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 756-760 )