中国药物警戒 ›› 2014, Vol. 11 ›› Issue (8): 472-477.

• 政策与法规研究 • 上一篇    下一篇

欧盟处方药与非处方药分类管理

刘靖杰, 杨悦*   

  1. 沈阳药科大学工商管理学院,辽宁 沈阳 110016
  • 收稿日期:2016-02-03 修回日期:2016-02-03 出版日期:2014-08-08 发布日期:2016-03-02
  • 通讯作者: 杨悦,女,教授,博士生导
  • 作者简介:刘靖杰,女,在读硕士,药品政策与药品分类管理制度。

Management of the Prescription and Non-Prescription Drugs Classification in EU

LIU Jing-jie, YANG Yue*   

  1. School of Business Administration, Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China
  • Received:2016-02-03 Revised:2016-02-03 Online:2014-08-08 Published:2016-03-02

摘要: 目的探索欧盟处方药与非处方药分类管理框架,继而分析其重点监管领域和转换工作,以期对我国药品分类管理工作提供借鉴。方法通过文献研究法研究欧盟管理经验、通过比较研究分析与我国的差异。结果欧盟药品分类管理体系完整、配套措施完善,重点领域监管严格,其经验值得我国借鉴。结论我国应在监管体系建立、标签、广告、配套措施管理及转换工作方面进一步完善。

关键词: 处方药, 非处方药, 分类管理, 转换

Abstract: ObjectiveTo make suggestion to regulatory authorities on the management of the classification, by exploring the classification framework of prescription and non-prescription drugs in EU, and analyzing the main regulatory areas and the change of classification of a medicinal product. MethodsLiterature study was used to research the experience of EU's management, then use the comparative study to analyze the differences. ResultsEU has rounded classification system, brilliant supporting measures and strict supervision of major field, which are worth reference. ConclusionWe need further improvement in the regulatory system, labeling, advertisement, supporting measure and switching.

Key words: prescription drug, non-prescription drug, classification, switching

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