医药导报2026，Vol.45Issue(6)：1057-1064,8.DOI:10.3870/j.issn.1004-0781.2026.06.017
药物临床试验新机构备案第三方评估问题分析
Analysis of Third-Party Evaluation Issues in the Filing of New Drug Clinical Trial Institutions
摘要
Abstract
Objective Based on third-party evaluation reports,this study aims to explore the problems in the registra-tion of new drug clinical trial institutions and provide suggestions,in order to provide reference for medical institutions planning to register.Methods Third-party evaluation reports were collected from 23 tertiary hospitals that completed initial registration from 2020 to 2025.A total of 516 on-site inspection issues were summarized,and quantitative analysis were performed based on expert consultation.Results Newly registered institutions for drug clinical trials in China mainly have four problems:docu-ment system(52.33％),hardware facilities(23.26％),personnel qualification(20.93％),and organizational structure(3.49％).Among them,the management document system is incomplete(40.37％),the operability is weak/inconsistent with the actual situation(21.11％),the pharmacy and drug storage facilities are unreasonable(40.00％),and there is insufficient mastery of regulation and management document requirements(50.93％),and 61.82％of the problems are concentrated in the professional group.Conclusions Newly registered institutions for drug clinical trials need to improve their document system,training incentives,hardware configuration,and ethical mechanisms,and collaborate with multiple parties to improve their filing management system.This study provides a targeted improvement path for the proposed filing institution.关键词
药物临床试验机构/机构备案/伦理委员会/专业组/管理文件Key words
Drug clinical trial institutions/Institutional filing/Ethics committee/Professional group/Manage files分类
医药卫生引用本文复制引用
董玉君,潘婷,戴炜均,余秋钿,程国华,欧阳舒婷..药物临床试验新机构备案第三方评估问题分析[J].医药导报,2026,45(6):1057-1064,8.基金项目
国家药品监督管理局药品审评检查大湾区分中心监管科学研究课题(GBA-JGKX-2403). （GBA-JGKX-2403）
