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中美药品监管机构基于风险的药品检查工作对比分析

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

Risk-basedDrug inspectionRegistrationComparison and analysis

李源、周刚

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国家药品监督管理局药品审评中心,北京 100076

基于风险 药品检查 注册核查 对比分析

2024

药学研究
山东省药品检验所 山东省药学会

药学研究

CSTPCD
影响因子:0.653
ISSN:2095-5375
年,卷(期):2024.43(1)
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