中国药物警戒 ›› 2012, Vol. 9 ›› Issue (4): 207-210.

• 管理及工作研究 • 上一篇    下一篇

欧盟药品说明书可读性指导原则简介与启示

赵智恒   

  1. 沈阳药科大学工商管理学院，辽宁 沈阳 110016
  • 收稿日期:2011-11-11 出版日期:2012-04-10 发布日期:2015-08-10
  • 作者简介:赵智恒，男，硕士研究生，药品政策，药品不良反应。

Introduction and Inspiration of the Guidance on the Readability of European Union Package Leaflet

ZHAO Zhi-heng   

  1. College of Business Administration, Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China
  • Received:2011-11-11 Online:2012-04-10 Published:2015-08-10

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摘要： 针对药品说明书进行可读性研究可以改善说明书的质量，使阅读人群更好地理解其中的信息，确保患者用药安全。可读性研究还可以推动药品授权经销商更好地制定药品说明书，故本文以欧盟药品说明书可读性研究法律体系为研究对象，将其药品说明书可读性研究的指导原则进行归纳整理，以期对我国药品说明书可读性研究的发展起到推动作用。

关键词: 药品说明书, 可读性研究, 欧盟

Abstract: The readability research of the package leaflet can improve its quality, make readers understand information in it and ensure its safety to patients. The readability research can also help marketing authorisation holders to design a better package leaflet. So the article takes legal system of the readability of European Union package leaflet as the object, Collate and analyze the readability guideline of package leaflet, look forward to promoting our pharmaceutical research and development.

Key words: package leaflet, readability research, European Union