摘要
为了建设来源可查、去向可追、责任可究的药品追溯体系,通过文献检索分析美国、欧盟、中国现有药品追溯体系的特点,提炼出对我国现有药品追溯体系的借鉴要点,提出了建立我国药品追溯体系的关注点:建立药品追溯制度,包括与药品追溯工作相关的人员、组织机构、设施设备、追溯文件及相应的药品追溯系统的管理要求,从而实现对药品供应链的可追溯及用药安全的全面管理。
In order to build a credible drug tracing system. the existing tracing system of USA, Europe, and China was investigated through the literature analysis. Finally, the main points were summarized for reference and key points were proposed to build a credible drug tracing system for our country. The tracing system must contain relevant personnel, organizational institution, facilities, tracing documents and management requirements of traceability system, so as to ensure the traceability of drug supply chain and medication safety in our country.
作者
黄薇薇
华佳
Huang Weiwei Hua Jia(Shanghai Pharmaceutical Co., Ltd., shanghai 200331, China)
出处
《中国药事》
CAS
2016年第12期1232-1236,共5页
Chinese Pharmaceutical Affairs
关键词
药品追溯制度
药品供应链
电子监管码
来源可查
去向可追
责任可究
药品质量安全管理
drug tracing system
drug supply chain
electronic supervision code
sources available
traceability
responsibility
drug quality and safety management
