我国药品上市许可持有人制度的实施现状及对策分析OACSTPCD
Analysis of the implementation status and countermeasures of drug marketing authorization holder system in China
药品上市许可持有人(MAH)制度是贯穿 2019 年《药品管理法》的核心制度和基本制度.本文汇总整理了我国MAH制度实施以来的制度文件,结合我国药品产业及监管实际情况并借鉴国际经验,提出强化持有人履责能力、探索建立统一且独立的药品跨省监管机制、探索建立独立于生产、质量管理体系之外的第三方监控体系和完善细化MAH制度的法规政策等建议,以期进一步发挥MAH制度在优化资源配置、落实持有人主体责任等方面的作用.
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.
干长姣;程立;元延芳;房军
国家药品监督管理局高级研修学院,北京 100073
药学
药品上市许可持有人制度委托生产药品监管
Marketing Authorization Holder systemCommissioned productionDrug regulation
《药学研究》 2024 (005)
449-454 / 6
国家药品监督管理局高级研修学院院内基金(No.NMPAIED102022008)
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