中美药品监管机构基于风险的药品检查工作对比分析  

Comparison and analysis of risk-based drug inspection between NMPA and US FDA

作　　者：李源 周刚 LI Yuan;ZHOU Gang(Center for Drug Evaluation,National Medical Products Administration,Beijing 100076,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100076

出　　处：《药学研究》2024年第1期93-98,共6页Journal of Pharmaceutical Research

摘　　要：为持续探索完善我国基于风险启动药品注册核查的工作方法,本文对美国药品检查相关的机构和法规文件,以及批准前检查和监督检查的工作程序等进行了阐述,通过对比分析我国在实施基于风险的药品注册核查工作中存在的不足,并提出具体建议,促进我国基于风险的药品注册核查更加科学和规范化。In order to continue to explore and improve the working methods of risk-based drug inspection in China,this paper describes the institutions,regulatory documents and implementation procedures related to drug inspection in the United States,and analyzes the shortcomings in the implementation of risk-based drug registration inspection in China through comparison.Some specific suggestions are put forward to promote more scientific and standardized risk-based drug registration inspection in our country.

关 键 词：基于风险 药品检查 注册核查 对比分析 

分 类 号：R95[医药卫生—药学]