摘要
目的:对比中英两国药品不良反应(adverse drug reaction,ADR)监测制度的不同,加强和完善我国ADR监测体系的建设。方法:从监测主管机构、监管范围以及报告原则等方面系统比较分析中英两国之间的ADR监测制度。结果:英国实行中央集中管理ADR监测体系,而中国采用国家、省级以及省级以下的三级ADR监测体系;英国以黑色倒三角符号标志重点监测药物,新药监测期为2年,中国对新药和进口药5年内进行重点监测;英国根据不同报告主体设计表格,而中国采用统一模式设计表格。结论:应积极学习和借鉴英国ADR监测制度的优点,进而完善我国ADR监测制度。
Objective： In order to strengthen and improve the construction of adverse drug reaction（ ADR） monitoring system,comparising between China and UK ADR monitoring system. Methods： The distinction of ADR monitoring system between the China and UK was analyzed from the aspects of the monitoring system,the scope of supervision and the principle of report system. Results： The UK implements the centralized management of ADR monitoring system,while China carries out countries,provincial and provincial tertiary ADR monitoring system; UK attaches importance to the key drug monitoring and signs them with black inverted triangle symbols and the period will last for 2 years,meanwhile the new drugs within 5 years were focused on monitoring in China; UK could design tables according to different require and purpose,however China adopt the unified design pattern table. Conclusion： We should pay more attention to the advantages of UK ADR monitoring system,and ameliorate the ADR monitoring system in China.
出处
《中国药物评价》
2015年第6期376-380,共5页
Chinese Journal of Drug Evaluation
基金
重大新药创制科技重大专项(2012ZX09304003-003)
国家人口与健康科学数据共享平台(2005DKA32406)
关键词
药品不良反应
监测制度
黄卡
Adverse drug reaction
Monitoring system
Yellow card
