监管科学视角下基于风险启动药品注册临床试验现场核查的新思考

New considerations for the risk-based initiation of drug registration clinical trial inspection from the perspective of regulatory science

为合理利用药品注册核查监管资源、加强对于药品研发过程的监管,我国药品监管机构根据我国医药产业发展现状,并参考国外药品监管实践建立了“基于风险”和“基于技术审评工作需要”的药品注册核查启动模式,提升了注册核查的针对性和效能,优化了我国药品注册管理体系,在一定程度上促进了医药产业的高质量发展。但在监管实践探索中仍然存在风险因素识别不够全面、风险模型构建考量因素不够深入等问题。本文分析了国内外药品监管机构启动药品注册临床试验现场检查的工作模式,并基于我国监管工作现状和经验,为优化药品注册临床试验现场核查启动工作提出几点建议和参考。

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.