| 药物临床试验机构备案要求及常见问题分析 |
| |
| 引用本文： | 宁靖,吴昊,高荣. 药物临床试验机构备案要求及常见问题分析[J]. 中国临床药理学杂志, 2021, 0(1) |
| |
| 作者姓名： | 宁靖 吴昊 高荣 |
| |
| 作者单位： | 国家药品监督管理局食品药品查验中心 |
| |
| 摘 要： | 2019-12-01药物临床试验机构开始实行备案管理。本文结合药物临床试验机构备案平台构建思路,着重介绍了备案平台的结构组成以及相关要求,梳理了药物临床试验机构备案过程中的常见问题,对机构如何满足备案要求进行分析和探讨,为药物临床试验机构更快更好地进行备案提供参考。
|
| 关 键 词： | 药物临床试验机构 机构备案 备案平台 |
Requirements and common issues in the registration system for drug clinical trial institutions |
| |
| NING Jing,WU Hao,GAO Rong. Requirements and common issues in the registration system for drug clinical trial institutions[J]. The Chinese Journal of Clinical Pharmacology, 2021, 0(1) |
| |
| Authors: | NING Jing WU Hao GAO Rong |
| |
| Affiliation: | (Center for Food and Drug Inspection of National Medical Products Administration,Beijing 100044,China) |
| |
| Abstract: | Since December 1,2019,the drug clinical trial institutions registration came into force.In association with the framework of the institutions registration system,this paper focused on the structure and relevant requirements of the registration system,sorted out the common issues in the registration process of the institutions,analyzed and discussed how the institutions meet the registration requirements,provided reference for the institutions to register faster and better. |
| |
| Keywords: | drug clinical trial institutions institutions registration registration system |
| 本文献已被 维普 等数据库收录！ |
|
