甘肃省人民医院药物临床试验人类遗传资源管理情况与思考  

Management of human genetic resources for drug clinical trials in Gansu Provincial Hospital

作　　者：段博文 杨孝来[1] 张文静 赵佩[1] 于静[1] DUAN Bowen;YANG Xiaolai;ZHANG Wenjing;ZHAO Pei;YU Jing(Department of Pharmacy,Gansu Provincial Hospital,Gansu Province,Lanzhou730000,China;School of Pharmacy,Ningxia Medical University,Ningxia Hui Autonomous Region,Yinchuan750000,China)

机构地区：[1]甘肃省人民医院药剂科,甘肃兰州730000 [2]宁夏医科大学药学院,宁夏银川750000

出　　处：《中国当代医药》2024年第20期133-136,141,共5页China Modern Medicine

基　　金：甘肃省自然科学基金项目(22JR5RA680)。

摘　　要：人类遗传资源是推动新药研发、助力人类健康研究的重要资源,也是维护国家安全的重要内容。近年来,我国发布多项法律法规以规范人类遗传资源的合理使用,明确人类遗传资源采集、利用和出境等具体流程和措施。药物临床试验机构作为新药研发的参与者,应遵守法律法规,不断完善人类遗传资源管理体系,对人类遗传资源进行有效保护。本研究通过回顾2020—2022年甘肃省人民医院药物临床试验机构涉及人类遗传资源项目审批类型、数量和原因,分析《人类遗传资源管理条例实施细则》实施后对涉及人类遗传资源项目审批可能产生的变化,结合药物临床试验全流程人类遗传资源管理实践,对建立人类遗传资源管理制度、组织培训、优化管理流程等提出建议,以进一步提高人类遗传资源管理水平。Human genetic resources are important resources to promote the research and development of new drugs,help human health research,and also an important part of safeguarding national security.In recent years,our country has issued a number of laws and regulations to regulate the rational use of human genetic resources and clarify specific processes and measures such as collection,utilization and exit of human genetic resources.Drug clinical trial institutions,as participants in the research and development of new drugs,should abide by laws and regulations,constantly improve the management system of human genetic resources,and effectively protect human genetic resources.This study reviewed the types,quantities and reasons for the approval of projects involving human genetic resources in drug clinical trial institutions of Gansu Provincial Hospital from 2020 to 2022,analyzed the possible changes in the approval of projects involving human genetic resources after the implementation of the Implementation Rules of the Regulations on the Management of Human Genetic Resources,and combined with the management practice of human genetic resources in the whole process of drug clinical trials.To further improve the management level of human genetic resources,suggestions are put forward for establishing the management system of human genetic resources,organizing training and optimizing the management process.

关 键 词：人类遗传资源 药物临床试验 管理 建议 

分 类 号：R95[医药卫生—药学]