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中国医药导刊 ›› 2023, Vol. 25 ›› Issue (12): 1207-1212.

• 专栏:药物警戒 • 上一篇    下一篇

我国医药企业药物警戒组织机构命名考虑要点和建议

徐菊萍1, 王广平2*, 万帮喜1   

  1. 1.上海太美星云数字科技有限公司, 上海 200233;
    2.上海市药品和医疗器械不良反应监测中心, 上海 200040

  • 收稿日期:2023-06-26 修回日期:2023-12-14 出版日期:2023-12-28 发布日期:2024-02-18
  • 基金资助:
    中国药品监督管理研究会2022年度研究课题[项目编号:2022-Y-Y-012;项目名称:药品监管质量管理规范(GRP)体系流程和标准建设路径研究]

Points to Considerations and Suggestions for the Naming of Pharmacovigilance Organizations

  1. 1.Shanghai Taimei Digital Technology Co., Ltd., Shanghai 200233, China;
    2.Shanghai ADR Center, Shanghai 200040, China
  • Received:2023-06-26 Revised:2023-12-14 Online:2023-12-28 Published:2024-02-18

摘要: 目的:探讨我国医药企业药物警戒组织机构名称设置的要求和原则,旨在为医药企业药物警戒组织机构命名提供思路和建议。方法:采用理论研究、文献分析对比法,整理和分析药物警戒部门内涵、法律法规要求以及通用命名原则,并结合医药企业、医疗机构和监管机构各药物警戒机构命名实践,归纳和总结不同组织机构名称的优缺点,探讨我国医药企业药物警戒组织机构名称设置的命名缘由、要点考虑及其原则和相关建议。结果:基于对药物警戒组织机构不同命名实践的分析,提出行业适用的药物警戒组织机构名称,逐渐规范药物警戒组织机构的命名,避免使用产生歧义的名称。结论:通过分析药物警戒组织机构名称,适宜的组织机构名称可以体现其设置的合理性和价值感,结合我国当前药物警戒制度的发展进程,对尚未组建药物警戒机构的企业能够有所借鉴。

关键词: 组织机构名称, 药物警戒部门, 要点, 原则, 推荐

Abstract: Objective: To discuss the possible reasons for the naming of pharmacovigilance organizations of pharmaceutical enterprises in China, which is order to provide some ideas and suggestions for the naming of the pharmacovigilance organizations in pharmaceutical enterprises. Methods: By adopting the methods of theory research, literature analysis and comparative study,we sort out and analyze the meaning, significance,regulatory requirements and general naming principles of pharmacovigilance departments names from industry, hospital and health authority organizations. With the combination of the naming practices of various pharmacovigilance agencies,it provides the possible reasons to sum up the advantages and disadvantages of the names of different organizations. This paper is in order to discuss the considerations and principles for the pharmacovigilance organizations of pharmaceutical enterprises in China, and to put forward some relevant recommendations. Results: Based on the analysis of different naming practices of pharmacovigilance organizations, to propose applicative names for industry, the common names of pharmacovigilance organizations in the industry were summarized, and the names of pharmacovigilance organizations were gradually standardized to avoid the use of ambiguous names. Conclusion: After analysis organization names, appropriate name could improve rationality and sense of pharmacovigilance value. With the development of China pharmacovigilance and the frequency which is hopefully helpful to the companies have not established such organization.

Key words: Organization name, Pharmacovigilance department, Considerations, Principles, Recommendation

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