摘要
美国药品监管已有百年历史,已形成科学、系统、全面和可操作的法规体系。为了进一步加强对上市后药品安全的监测,2007年美国食品药品管理修正案(Food and Drug Administration Amendment Act,FDAAA)推出风险评估和减低计划(Risk Evaluation and Mitigation Strategies,REMS),本文从REMS的历史、主要内容、执行情况及各方对REMS的讨论等方面详细介绍REMS,以期为我国药品风险管理提供借鉴。
The drug regulation of USA has a history of one hundred years, which has formed a scientific, systematic, comprehensive and operable system of laws and regulations. To improve monitoring of postmarketing drug safety, Risk Evaluation and Mitigation Strategies was launched by Food and Drug Administration Amendment Act in 2007. This article focused on the history, contents, implementation, discussions from different departments and so on, in order to give some references for the drug risk management in China.
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2014年第6期425-429,共5页
Chinese Journal of New Drugs and Clinical Remedies
关键词
美国食品和药物管理局
风险评估和减低计划
药物评价
风险调节
United States food and drug administration
risk evaluation and mitigation strategies
drug evaluation
risk adjustment
