摘要
目的:本文就药品上市许可持有人(MAH)制度下委托生产的监管策略进行探讨。方法:对MAH制度下的委托生产进行风险识别,借鉴国外监管机制,探索MAH制度下委托生产的监管策略。结果:为MAH制度下委托生产尤其是跨省委托生产的监管策略提供建议。结论:建议建立可操作的监管机制,推进药品上市制度改革,保证药品质量安全。
Objective： To discuss the regulatory strategy for contract manufacturing under marketing authorization holder（MAH） system. Methods： The risks of the contract manufacturing under MAH system was identified and the regulatory strategy for contract manufacturing was explored by referring to foreign relevant experiences. Results： The advice on regulatory strategy for contract manufacturing was provided, especially when the holder and the manufacturer are located in different provinces. Conclusion： The operational regulatory mechanisms for contract manufacturing should be established so as to further promote the reform of drug listing system and ensure the drug quality and safety.
作者
颛孙燕
ZHUANSUN Yan(Shanghai Center for Drug Evaluation and Inspection,Shanghai 201203,China)
出处
《上海医药》
CAS
2018年第13期48-51,共4页
Shanghai Medical & Pharmaceutical Journal
关键词
药品上市许可持有人
委托生产
监管策略
marketing authorization holder
contract manufacturing
regulatory strategy
