Page 29 - 《中国药房》2025年3期
P. 29
2017/content_5232362.htm. [ 8 ] 王甜甜,杨芳芳,李思奇,等. 备案制下贵州省药物临床
[ 2 ] 国家药品监督管理局,国家卫生健康委员会. 药物临床 试验机构发展现状分析[J]. 中国药事,2024,38(7):
试验机构管理规定[EB/OL].[2024-06-08]. https://www. 763-767.
gov.cn/gongbao/content/2020/content_5496785.htm. WANG T T,YANG F F,LI S Q,et al. Analysis on the cur‐
National Medical Products Administration, National rent development state of drug clinical trial institutions in
Health Commission. Administrative regulations of drug Guizhou Province under the registering system[J]. Chin
clinical trial sites[EB/OL].[2024-06-08]. https://www.gov. Pharm Aff,2024,38(7):763-767.
cn/gongbao/content/2020/content_5496785.htm. [ 9 ] 林小倩,黄芳玲,郑铃. 福建省药物临床试验机构备案现
[ 3 ] 唐仕炜,刘泽玉,谷娟,等 . 我国药物临床试验机构地域 状分析[J]. 中国药事,2024,38(5):558-566.
和专业分布现状与思考[J]. 中国药业,2018,27(24):1-4. LIN X Q,HUANG F L,ZHENG L. Analysis of the cur‐
TANG S W,LIU Z Y,GU J,et al. Current situation and rent registering situation of drug clinical trial institutions
thought of geographical and professional distribution of in Fujian province[J]. Chin Pharm Aff,2024,38(5):
good clinical practice institutions in China[J]. China 558-566.
Pharm,2018,27(24):1-4. [10] 张勋,邹燕琴,陈燕,等. 广东省药物临床试验机构备案
[ 4 ] 尤玉芳,高菲菲,许璇,等. 备案制后我国药物临床试验 情况及监管现状分析[J]. 中国医药导刊,2024,26(6):
机构现状分析[J]. 中国新药与临床杂志,2023,42(3): 555-559.
170-174. ZHANG X,ZOU Y Q,CHEN Y,et al. Analysis on the fi-
YOU Y F,GAO F F,XU X,et al. Analysis on present ling and supervising status of drug clinical trial institu‐
situation of drug clinical trial institutions in China after tions in Guangdong Province[J]. Chin J Med Guide,2024,
implementation of registration system[J]. Chin J New 26(6):555-559.
Drugs Clin Remedies,2023,42(3):170-174. [11] 宁靖,吴昊,高荣. 药物临床试验机构备案要求及常见问
[ 5 ] 杨雅莉,李娟. 备案制后四川省药物临床试验机构现状 题分析[J]. 中国临床药理学杂志,2021,37(1):3-7.
分析[J]. 中国药事,2021,35(9):988-993. NING J,WU H,GAO R. Requirements and common is‐
YANG Y L,LI J. Analysis on the present situation of drug sues in the registration system for drug clinical trial institu‐
clinical trial institutions in Sichuan Province after the tions[J]. Chin J Clin Pharmacol,2021,37(1):3-7.
registration system[J]. Chin Pharm Aff,2021,35(9): [12] 张莹莹,李晶,李明,等. 机构备案制下临床试验工作开
988-993. 展的几点思考[J]. 中国新药杂志,2022,31(6):586-589.
[ 6 ] 王宏伟,李彩霞. 内蒙古自治区药物临床试验机构备案 ZHANG Y Y,LI J,LI M,et al. Several thoughts on con‐
现状分析与思考[J]. 北方药学,2022,19(4):192-196. duction of clinical trials under institution registration sys‐
WANG H W,LI C X. Analysis and reflection on the cur‐ tem[J]. Chin J New Drugs,2022,31(6):586-589.
rent situation of drug clinical trial institutions’s record- [13] 崔慧霞,李海菊,宋岩珺,等. 备案制下新的药物临床试
keeping of the Inner Mongolia[J]. J N Pharm,2022,19 验机构运行分析[J]. 中国药物与临床,2020,20(22):
(4):192-196. 3847-3849.
[ 7 ] 张娟利,刘美佑,樊婷婷,等. 陕西省药物临床试验机构 CUI H X,LI H J,SONG Y J,et al. Analysis on the opera‐
现状分析[J]. 中南药学,2024,22(2):548-552. tion of new drug clinical trial institutions under the filing
ZHANG J L,LIU M Y,FAN T T,et al. Current situation system[J]. Chin Remedies Clin,2020,20(22):3847-3849.
of drug clinical trial institutions in Shaanxi province[J]. (收稿日期:2024-08-16 修回日期:2024-12-15)
Cent South Pharm,2024,22(2):548-552. (编辑:林 静)
中国药房 2025年第36卷第3期 China Pharmacy 2025 Vol. 36 No. 3 · 279 ·