Li Yuanyuan, Xie Yanming
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Zhongguo Zhong Yao Za Zhi. 2011 Oct;36(20):2825-7.
The FDA risk evaluation and mitigation strategy (REMS) aims to drugs or biological products known or potential serious risk management. Analysis with the example of the content of the Onsolis REMS named FOCOS. Our country can be reference for the analysis of relevant experience and establish a scientific evaluation mechanism, strengthen the drug risk consciousness, promote the rational drug use, organic combined with the before-marketing and post-marketing evaluation of traditional Chinese medicine, and promote the evaluation of risk management of the drug development and improvement.
美国食品药品监督管理局（FDA）的风险评估与缓解策略（REMS）旨在对已知或潜在具有严重风险的药物或生物制品进行风险管理。以名为FOCOS的Onsolis REMS内容为例进行分析。我国可借鉴相关经验分析，建立科学的评估机制，强化药品风险意识，促进合理用药，将中药上市前与上市后评价有机结合，推动药品风险管理评价的发展与完善。
