目的：探讨备案制实施后，河北省药物临床试验机构的发展现状，旨在进一步提升河北省药物临床试验的整体水平，推动区域医药产业发展。方法：查询药物临床试验机构备案管理信息平台和药物临床试验登记与信息公示平台，收集并梳理河北省药物临床试验机构在备案制实施5年内的相关数据，从备案机构数量、地域分布、备案专业情况、主要研究者分布，承接项目情况、监管现状等方面进行分析。结果：截至2024年12月31日，河北省共备案68家药物临床试验机构，增幅94%，11个地级市均有分布。备案109个专业、主要研究者993人，主要集中在高校附属医院。登记临床试验项目4599项，5家登记临床试机构承接项目数超过300项，占河北省46%的药物临床试验。各临床试验机构接收监督检查252次，部分药物临床试验机构在试验数据质量、受试者安全、备案信息规范等方面存在问题。结论：药物临床试验机构备案制的实施显著加快了河北省药物临床试验机构的建设进程。但河北省药物临床试验机构存在区域发展亟待平衡、承接项目能力亟待提高、药物临床试验综合能力亟待提升等系列问题，需进一步优化区域布局，提升新机构承接能力，强化综合能力建设，针对河北省药物临床试验机构存在的问题提出改进措施，以推动河北省药物临床试验高质量发展。

Objective： To explore the development status of drug clinical trial institutions in Hebei Province after the filing system， aming to further enhance the overall level of drug clinical trials in Hebei Province and promote the development of the regional pharmaceutical industry.Methods： Data related to drug clinical trial institutions in Hebei Province during the five years of the filing system were obtained and sorted out from the two websites， analysis was made on the number of registered institutions， regional distribution， filing majors， principal investigators， status of clinical trial undertaked， supervision status.Results： As of November 31，2024， a total of 68 drug clinical trial institutions have been filed in Hebei Province， swith an increase of 94%， all 11 prefecture-level cities were distributed. 109 majors and 993 PIs had been registered， primarily concentrated in university-affiliated hospitals. A total of 4 599 clinical trial projects were registered， with 5 institutions each undertaking over 300 projects， accounting for 46% of Hebei's drug clinical trials. At various clinical trial institutions， a total of 252 inspections were conducted. There were issues found with some drug clinical trial institutions regarding data quality， participant safety， and compliance with registration information standards during these inspections.Conclusion： The construction process of drug clinical trial institutions in Hebei Province has been significantly accelerated by filing management. However， there are a series of issues that remain， including the urgent need to balance regional development， improve project undertaking capacity， and enhance the comprehensive capabilities of drug clinical trials in Hebei Province. It is necessary to further optimize regional layouts， enhance the capacity of new institutions to undertake projects， and strengthen comprehensive capability building to promote the high-quality development of drug clinical trials in Hebei Province.