• 中国核心期刊(遴选)数据库收录期刊
  • 中文科技期刊数据库收录期刊
  • 中国期刊全文数据库收录期刊
  • 中国学术期刊综合评价数据库统计源期刊等

• 管理研究 • 上一篇    

国内外药用辅料变更管理制度研究

阎文君   

  1. 沈阳药科大学
  • 收稿日期:2019-03-28 修回日期:2019-04-04 出版日期:2019-04-25 发布日期:2019-04-25

Research on the Management System of Pharmaceutical Excipients Change at Home and Abroad

Yanwenjun   

  1. Shenyang Pharmaceutical University
  • Received:2019-03-28 Revised:2019-04-04 Online:2019-04-25 Published:2019-04-25

摘要: 药用辅料是药物制剂的重要组成部分,对保证药品质量至关重要。本文通过对国外药用辅料变更管理制度的研究及对我国药用辅料变更管理制度的梳理,提出辅料变更管理建议,以期在我国药用辅料监管改革及仿制药一致性评价深入推进的过程中,优化药用辅料变更管理,加快推动医药产业向更健康的方向发展。

Abstract: As the essential components of dosage form, pharmaceutical excipients play a important role in assuring drug quality. This article has put forward scientific and reasonable suggestions to the management of pharmaceutical excipients change by studying management systems at home and abroad. In order to improve the management of pharmaceutical excipients change and promote the development of pharmaceutical industry in a healthy way during the process of reforming pharmaceutical excipients management and advancing the consistency evaluation of generic drugs.