目的： 药品上市许可持有人制度实施后,仅委托生产的持有人数量不断增加,带来潜在的风险隐患。本研究旨在对仅委托生产的药品上市许可持有人完善质量管理体系和监管部门制定举措提供参考。方法： 以江苏省内企业为研究对象,开展仅委托生产的药品上市许可持有人质量管理现状调查,发现其质量管理方面存在的问题,分析原因并提出建议。结果： 仅委托生产的药品上市许可持有人基础相对薄弱,质量管理存在质量安全主体责任落实不到位、质量和风险管控能力不足等问题,其原因主要为质量意识薄弱、合作匹配不易、主体地位弱势、体系衔接困难等。结论： 仅委托生产的药品上市许可持有人应积极履行质量安全主体责任,药品监管部门可以采取创新监管方式、强化行政指导等措施,不断完善质量管理体系,优化监管举措,保障药品质量和用药安全。

Objective: The number of marketing authorization holders (MAHs) only commissioning production is constantly increasing after the implementation of the MAH system, which brings risks. The aim of the research is to provide workable proposals for the quality management of MAH and drug regulatory anthorities. Methods: Taking the enterprises in Jiangsu province as the research object, the quality management status of MAH only commissioning drug production was investigated, the existing problems in quality management were found, the causes were analyzed and suggestions were put forward. Results: There were some unique problems such as inadequate implementation of quality and safety main responsibilities, insufficient quality and risk control capabilities in the quality management system of the MAH, which were mainly caused by weak quality awareness, difficulty cooperation and matching, weak subject status, and difficulty in quality system connection. Conclusion: MAH only commissioning drugs should actively fulfill the main responsibicity of quality and safety, and drug regulatory authorities can take measures such as inovating regulatory methods and strengthening adminiatrative guidance to continuously improve the quality management system and optimize regulatory measures to ensure drug quality and drug safety.