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中国医药导刊 ›› 2021, Vol. 23 ›› Issue (6): 458-461.

• 管理与实践 • 上一篇    下一篇

药品生产企业执业药师分布现状及建议

李朝辉, 许龙, 徐艳, 周玥   

  1. 国家药品监督管理局执业药师资格认证中心, 北京 100061
  • 收稿日期:2021-04-09 修回日期:2021-05-08 出版日期:2021-06-28 发布日期:2021-06-28

Distribution Status and Suggestions on Licensed Pharmacists in Drug Manufacturing Enterprises

  1. Certification Center for Licensed Pharmacist of National Medical Products Administration, Beijing 100061, China
  • Received:2021-04-09 Revised:2021-05-08 Online:2021-06-28 Published:2021-06-28

摘要: 目的:为进一步发挥药品生产企业执业药师作用提供参考。方法:通过梳理药品生产企业执业药师制度要求和药品生产企业执业药师分布现状,分析存在的问题并提出建议。结果:目前我国药品生产企业执业药师作用难以发挥,药品生产企业取得执业药师资格者注册积极性不高;部分药品生产企业责任意识淡薄,未按要求配备执业药师作为质量管理人员。结论:建议在《药师法》中明确药品生产企业执业药师责权利,督促药品生产企业履行药品质量第一责任人职责,加强执业药师配备使用,促使执业药师更好地发挥作用,确保药品生产质量,保障人民用药安全。

关键词: font-size:medium, ">执业药师;药品生产企业;药师法;制度要求;分布现状;药品质量

Abstract: Objective: To provide reference for further exerting the role of licensed pharmacists in drug manufacturing enterprises. Methods: By sorting out the institutional requirements and the distribution status of licensed pharmacists in drug manufacturing enterprises, to analyze the existing problems and give suggestions . Results: Currently, the role of licensed pharmacists is difficult to play in drug manufacturing enterprises, and the pharmaceutical technicians who have obtained licensed pharmacists qualification lack enthusiasm for regeitration in drug manufacturing enterprises. Some drug manufacturing enterprises lack the sense of responsibility and didn′t assign licensed pharmacists as quality management personnel as required. Conclusion: It is recommended to clarify the responsibilities and rights of licensed pharmacists in drug manufacturing companies in the Pharmacist Law, urge drug manufacturers to perform their duties as the principal responsible person for drug quality, strengthen the deployment and use of licensed pharmacists, and encourage licensed pharmacists to better play their roles, ensure the quality of drug production, and ensure drug safety for the public.

Key words: font-size:medium, ">Licensed pharmacist; Drug manufacturing enterprises; Pharmacist Law; Institutional requirements; Distribution status; Drug quality

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