中国药物警戒 ›› 2013, Vol. 10 ›› Issue (4): 210-214.
• 政策与法规研究 • 上一篇 下一篇
赵频,许美婷,杨悦
收稿日期:
修回日期:
出版日期:
发布日期:
通讯作者:
作者简介:
ZHAO Pin ,XU Mei-ting, YANG Yue
Received:
Revised:
Online:
Published:
摘要: 美国食品药品监督管理局于2008年3月开始实施旨在控制药品使用风险的风险评估与减低策略(REMS)。经过4 年多的实践,FDA 对该策略进行了部分调整和完善,本文通过对REMS 的实施现状及其未来发展趋势进行分析,以期对我国药品风险干预提供借鉴。
关键词: 风险评估和减低策略, 实施现状, 发展趋势
Abstract: To control the risk of drug well, FDA began to implement Risk Evaluation and Mitigation Strategy in March 2008. For almost four years, it has experienced partial adjustment and improvement. This article makes an analysis of current situation and trend of Risk Evaluation and Mitigation Strategy to provide suggestions and references for domestic measures of drug risk intervention.
Key words: REMS, current situation of implementation, trend
赵频,许美婷,杨悦 . FDA风险评估与减低策略实施现状及趋势分析[J]. 中国药物警戒, 2013, 10(4): 210-214.
ZHAO Pin ,XU Mei-ting, YANG Yue. Analysis on Current Situation and Trend of FDA's Risk Evaluation and Mitigation Strategy [J]. Chinese Journal of Pharmacovigilance, 2013, 10(4): 210-214.
0 / 推荐
导出引用管理器 EndNote|Ris|BibTeX
链接本文: https://www.zgywjj.com/CN/
https://www.zgywjj.com/CN/Y2013/V10/I4/210