药学研究2024，Vol.43Issue(5)：449-454,6.DOI:10.13506/j.cnki.jpr.2024.05.007
我国药品上市许可持有人制度的实施现状及对策分析
Analysis of the implementation status and countermeasures of drug marketing authorization holder system in China
摘要
Abstract
The Marketing Authorization Holder(MAH)system is the core and basic system throughout the Drug Administration Law of the People's Republic of China.To further leverage the role of the MAH system in optimizing resource allocation and implementing the primary responsibility of holders,institutional documents since the implementation of the MAH system in China has been summarized and organized.Based on the actual situation of China's pharmaceutical industry and its regulation,as well as drawing on international experience,targeted improvement suggestions are proposed.Such as strengthening the holders to perform their duties responsibly,exploring the establishment of a unified and independent cross-provincial regulatory mechanism and a third regulator,and improving the laws and regulations of the MAH system.关键词
药品上市许可持有人制度/委托生产/药品监管Key words
Marketing Authorization Holder system/Commissioned production/Drug regulation分类
药学引用本文复制引用
干长姣,程立,元延芳,房军..我国药品上市许可持有人制度的实施现状及对策分析[J].药学研究,2024,43(5):449-454,6.基金项目
国家药品监督管理局高级研修学院院内基金(No.NMPAIED102022008) （No.NMPAIED102022008）
