摘要
目的:了解我国施行药物临床试验备案制后,内蒙古自治区药物临床试验机构现状。方法:通过国家药品监督管理局官网发布的全国及内蒙古自治区药物临床试验机构备案数据及已开展项目数据,对内蒙古自治区药物临床试验机构备案情况及试验开展情况进行统计分析。结果:近4年来,内蒙古自治区的药物临床试验得到飞速发展,但仍处于落后水平。结论:内蒙古自治区药物临床试验机构的建设和管理仍需加快步伐,提高整体水平。
Objective:To understand the present situation of drug clinical trial institutions in Inner Mongolia province after the implementations of drug clinical trial institutions in China.Methods:According to the data of national and Inner Mongolia drug clinical trial institutions in projects launched by the State Drug Administration in official website,statistical analysis was conducted on the record and trial implementation of Inner Mongolia.Results and Conclusion:In the last four years,drug clinical trials in Inner Mongolia have grown rapidly,but they are still lagging behind.The construction and management of Inner Mongolia drug clinical trial institutions still need to be stepped up to improve the overall level.
作者
王宏伟
李彩霞
WANG Hongwei;LI Caixia(The Drug Clinical Trial Institution,Inner Mongolia Medical College Affiliated People’s Hospital,Inner Mongolia,huhhot 010020,China)
出处
《北方药学》
2022年第4期192-196,共5页
Journal of North Pharmacy
关键词
药物临床试验机构
备案
分析
Drug clinical trial institution
Record-keeping
Analysis
