药品上市许可持有人委托生产安全监管问题与对策

Safety Supervision Problems and Countermeasures of Production Entrustment by Drug Marketing Authorization Holders

文章通过分析药品上市许可持有人委托生产安全监管存在的问题,探索药品上市许可持有人委托生产监管的对策。基于MAH委托生产现状识别风险与挑战,提出安全监管对策。通过建立动态风险监管和多元化监管来协调监管机制,不断完善委托生产相关政策文件,进一步推动我国制药行业高质量发展。

This paper explores the countermeasures of drug marketing authorization holder's entrustment production supervision by analyzing the problems existing in the safety supervision of drug marketing authorization holder's entrustment production.Based on the current situation of MAH commissioned production identify risks and challenges,and safety supervision countermeasures are proposed.By establishing the dynamic risk supervision and diversified supervision to coordinate supervision mechanism,the relevant policy documents of commissioned production are improved,and the high-quality development of China's pharmaceutical industry is further promoted.