中国药业2026，Vol.35Issue(12)：18-24,7.DOI:10.3969/j.issn.1006-4931.2026.12.004
我国妇幼专科医院药物临床试验机构发展现状分析
Analysis on the Development Status of Drug Clinical Trial Institutions in Maternal and Child Specialized Hospitals in China
摘要
Abstract
Objective To analyze the current status of drug clinical trial institutions in maternal and child specialized hospitals(hereinafter referred to as maternal and child specialized GCP institutions)in China.Methods Data were retrieved from the official website of the National Medical Products Administration,and the platform,related to drug clinical trial institutions.The retrieval period covered from February 2005 to November 2019(during the qualification certification period)and from December 2019 to December 2024(during the filing system period).The overall situation,geographical distribution,filed specialties,principal investigators(PIs),the overall situation of undertaken drug clinical trials,filing and trial undertaking situations by different institution types,and supervision and inspection situations of maternal and child specialized GCP institutions were counted and analyzed.Results After the implementation of the filing system,the number of maternal and child specialized GCP institutions increased from 42 to 94.There were significant differences in the distribution of institution numbers among 26 provincial-level administrative regions,with a clear concentration trend in the eastern and central regions.A total of 678 specialties were filed,with the speciaty of pediatrics(287,42.33%)and the speciaty of obstetrics and gynecology(123,18.14%)accounting for the majority.A total of 1 395 PIs were filed,and 3 282 clinical drug trials were undertaken,most of which were completed by affiliated hospitals of universities.The filing and undertaking of clinical drug trials exhibited a clear hierarchical differentiation pattern by institution type,with municipal hospitals being the most common among filed institutions(45,47.87%).A total of 285 supervision and inspection activities were conducted.The compliance rates of cause-initiated inspection(92.31%)and routine supervision inspection(91.51%)were relatively high,while the compliance rate of registration inspection was the lowest(72.22%).The average annual number of supervision and inspection per maternal and child specialized GCP institution was 0.81,showing prominent imbalance among different provinces.Conclusion In the past decade,maternal and child specialized GCP institution in China have high professional concentration and possess outstanding clinical advantages and sufficient patient resources in targeted fields.Nevertheless,they are faced with uneven regional distribution and distinct hierarchical gaps in filing scale and trial undertaking capacity.It is suggested to optimize the allocation of drug clinical trial resources and promote the research and development of maternal and child specific medications through policy incentives,technical innovation and establishment of maternal and child specialized medical alliances.关键词
妇幼专科医院/药物临床试验/机构备案/药品监管Key words
maternal and child specialized hospital/drug clinical trial/institutional filing/drug regulation分类
医药卫生引用本文复制引用
张立段,彭丽艳,于庆坤..我国妇幼专科医院药物临床试验机构发展现状分析[J].中国药业,2026,35(12):18-24,7.基金项目
河北省中医药类科研计划课题[2019207]. （）
