摘要
随着新药上市频率的加快,不断有新的、严重的、非预期的药品不良反应和不良事件出现,给广大患者的健康和生命造成了严重威胁。各国政府通过立法和制定相关指南来加强和规范药品上市后的不良反应监测和报告工作。我国政府部门也正积极开展相关工作,但存在诸如药品风险管理意识较弱、管理机构在法规操作上缺乏透明度等问题,本研究拟对国外相关法规和制度作初步探讨,以期为我国的药品不良反应监测和报告工作提供借鉴。
Following more and more new drugs are authorized into market, new, serious or unexpected adverse drug reactions appear frequently, which is a serious threat to people＇health and life. Through making laws and guidelines, governments of various countries aim to strengthen and standardize the surveillance and reporting of postmarketing drugs. The drugs management department of our country are doing related jobs positively, but there are some problems, such as drug risk-menagement is not emphasized well, and the management department lacks clarity on operating related regulations. This article tries to explore foreign countries＇ laws and regulations on the surveillance and reporting of postmarketing drugs, aiming to provide reference for our courtry.
出处
《中国中药杂志》
CAS
CSCD
北大核心
2009年第11期1464-1467,共4页
China Journal of Chinese Materia Medica
基金
科技部"重大新药刨制"科技重大专项(2009ZX09502)
关键词
国外
上市后药品
不良反应监测和报告
法规制度
foreign countries
postmarketing drugs
surveillance and reporting of adverse drug reactions
laws and regulations
