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上海市15家药品上市许可持有人的药物警戒体系存在问题与对策
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| 篇名： | 上海市15家药品上市许可持有人的药物警戒体系存在问题与对策 |
| TITLE： | Problems and countermeasures on pharmacovigilance system of 15 marketing authorization holders in Shanghai |
| 摘要： | 目的 为地方药品上市许可持有人（MAH）落实其药品全生命周期监管的主体责任和即将正式发布的《药物警戒检查指导原则》提供决策参考。方法以接受药物警戒检查的15家上海市MAH为研究对象，对检查结果采用社会网络分析方法探索MAH企业属性与检查问题项之间的逻辑关系，总结发现的问题并分析原因，同时提出相应对策。结果与结论本次药物警戒检查中发现的问题主要集中在组织机构、人员管理、质量管理体系、报告质量等方面。造成这些问题的原因包括处罚力度轻导致企业管理层对药物警戒制度不重视、问题处理和风险管控机制不明确、质量管理体系文件不完善、人员培训工作不到位等。据此，MAH需要提高对药物警戒工作的重视程度，配置相应的人力和资源，不断完善药物警戒质量管理体系，提升药物警戒体系的可执行性和有效性。同时建议政府部门加大政策引导和宣贯力度，结合行业协会等第三方机构平台，推动MAH顺利实施《药物警戒质量管理规范》。 |
| ABSTRACT： | OBJ ECTIVE To provide policy referen ce for local marketing authorization holder （MAH）to implement their main responsibility of drug life cycle supervision and the Guiding Principles of Pharmacovigilance Inspection to be officially released. METHODS Taking 15 MAH in Shanghai who recently underwent pharmacovigilance inspection as the research objects ，the social network analysis was used to explore the logical relationship between MAHs ’enterprise attributes and inspection problems ， summarize the problems found ，analyze the causes ，and put forward corresponding countermeasures. RESULTS & CONCLUSIONS The problems found in this pharmacovigilance inspection were mainly in aspects of organization ，personnel management ，quality management system ，report quality and so on. The reasons for these problems included light punishment ，which lead to the enterprise management ’s lack of attention to the pharmacovigilance system ，unclear problem handling and risk control mechanism ， imperfect quality management system documents ，inadequate personnel training ，etc. MAH needs to pay more attention to pharmacovigilance，allocate corresponding human and resources ，constantly improve the pharmacovigilance quality management system，and improve the enforceability and effectiveness of the pharmacovigilance system. At the same time ，it is suggested that government departments should strengthen policy guidance ， publicity and implementation ， and combine with third-party institutional platforms such as industry associations to promote the smooth implementation of Good Validation Practice . |
| 期刊： | 2022年第33卷第05期 |
| 作者： | 方乐敏，胡骏 |
| AUTHORS： | FANG Yuemin ，HU Jun |
| 关键字： | 药物警戒质量管理规范；药品上市许可持有人；药物警戒；药物警戒检查指导原则 |
| KEYWORDS： | Good Validation Practice ；MAH；pharmacovigilance；Guiding Principles of Pharmacovigilance Inspection |
| 阅读数： | 430 次 |
| 本月下载数： | 48 次 |
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