试论中药制剂安全性问题的风险控制  

Discuss on the Risk Control of Traditional Chinese Medicine

作　　者：吴承云[1] 黄文志[1] 郑清明[1] 张力[2] 周亚莉[1] 张承绪[2] 

机构地区：[1]四川省食品药品安全监测及评审认证中心,四川成都610017 [2]国家食品药品监督管理局药品评价中心,北京100045

出　　处：《中国药物警戒》2010年第10期607-610,共4页Chinese Journal of Pharmacovigilance

基　　金：国家十一五科技支撑课题"中药上市后安全性监测与再评价标准规范研究"(2006BAI21B11)

摘　　要：通过对相关的药品监督管理法律、法规的梳理及相关文献的查阅整理,结合我国中药制剂目前的现状,探讨中药安全性的影响因素。基于现行药品监管制度,明确各涉药机构中药安全性问题风险控制的责任及义务,阐述其风险控制方法及措施,为中药制剂安全合理应用服务。This essay based on analyzing the pertinent literature, unscrambling the correlative laws and regulations of drug administration in force, and combining the situation of Traditional Chinese Medicine（TCM）, The influential factors of TCM safety were discussed; as for the organizations relative to TCM, the responsibility and obligation were deter- mined to controlling the risks from TCM, how and take what measures to decrease the risks were stated as well.

关 键 词：中药制剂 风险控制 药品不良反应 

分 类 号：R954[医药卫生—药学]