摘要
为促进全国药品再注册工作更规范、科学、有效,成为强化药品安全管理、防范风险隐患的重要手段,文章通过研究国家食品药品监督管理局发布的相关法律法规及相关文献资料,结合安徽省2015年前三季度药品再注册审批工作的具体情况,对当前药品再注册工作中存在的问题进行归纳和分析,并提出相关建议。
The standard, scientific and effective drug license-renewed application is very important to improve management on drug safety and prevent drug-related risks. Based on researches of the related laws and regulation issued by SFDA and relevant lit- eratures,and combined with the data of approval on drug license-renewed application of Anhui in first three quarters of 2015 ,prob- lems of drug license-renewed application were analyzed. And some suggestions were put forward.
出处
《中国卫生事业管理》
北大核心
2016年第5期356-357,共2页
Chinese Health Service Management
基金
安徽高校人文社会科学重点研究基地招标项目"我国临床用药道德及法律保障研究--以安徽省为例"(SK2015A066)
关键词
药品再注册
现状
问题
建议
drug license-renewed application
status
problems
suggestions.
