| 杨雅莉,李娟.备案制后四川省药物临床试验机构现状分析[J].中国药事,2021,35(9):985-990 |
| 备案制后四川省药物临床试验机构现状分析 |
| Analysis on the Present Situation of Drug Clinical Trial Institutions in Sichuan Province after the Registration System |
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| DOI：10.16153/j.1002-7777.2021.09.004 |
| 中文关键词: 机构备案 药物临床试验机构 现状分析 |
| 英文关键词: institution registration drug clinical trial institutions situation analysis |
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| 中文摘要: |
| 目的：了解我国施行药物临床试验机构备案制后，四川省内药物临床试验机构的现状。方法： 通过国家药品监督管理局官网发布的四川省药物临床试验机构数据，对四川省药物临床试验机构发展、 地域分布、备案专业、主要研究者、Ⅰ期临床试验研究室等相关情况进行统计分析。结果与结论：备案制后四川省药物临床试验机构发展形势良好，但也存在一系列问题，本文针对这些问题提出了改进措施，意在能推动新增备案机构(2019年12月1日之前取得资格认定的机构不包含在内)的发展和整体水平的提高。 |
| 英文摘要: |
| Objective: To understand the present situation of drug clinical trial institutions in Sichuan province after the implementation of drug clinical trial institution registration in China. Methods: Based on the data of drug clinical trial institutions in Sichuan province released on the official website of National Medical Products Administration, statistical analysis was made on the development, regional distribution, archived majors, principal investigators and phase I clinical trial laboratories of drug clinical trial institutions in Sichuan Province. Results and Conclusion: After the implementation of drug clinical trial institution registration, the development of drug clinical trial institutions in Sichuan province is good, but there are a series of problems. Improvement measures were put forward to address these problems, aiming at promoting the development of new filing institutions (excluding those qualified before December 1, 2019) and the improvement of the overall level. |
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