我国试行药品上市许可持有人制度的对策研究

Trial implementation of marketing authorization holder in China: problems and solutions

为推进我国试行的药品上市许可持有人(MAH)制度的实施提出对策建议。主要通过文献研究及对比分析,厘清我国试行MAH制度的潜在问题。结果显示,我国试行该制度存在多方面问题,主要包括:新增持有人对药品质量安全的责任承担及风险控制能力不足,委托生产关系下生产企业的主动性和控制性下降,相应救济制度不完善,主体责任的法律约束性不强。基于此,在试行药品MAH制度过程中,我国应当加强药品监管,激发主体责任,完善药物警戒制度及救济制度,尽快制定并完善配套文件。

To push the implement of marketing authorization holder（MAH） in China, this article summarized the potential problems of MAH in China through literature review and comparative analysis, and put forward some suggestions for solving these problems. The trial of the system has many problems. The holder cannot afford the responsibilities to ensure the quality and safety of the drug or control the risk; commissioned enterprises lose the initiative; the relief system in China is imperfect; and the main persons in charge cannot be supervised seriously by laws. To solve these problems, China should strengthen drug regulations, stimulate the main responsibility, improve the pharmacovigilance system and relief system, and draw up and revise the supporting documents as soon as possible.