加强药物临床试验中人类遗传资源管理的思考  

Considerations of strengthening the human genetic resources management in drug clinical trials

作　　者：苏畅 徐玲燕 苏钰文 SU Chang;XU Lingyan;SU Yuwen(National Institute for Drug Clinical Trial,Sir Run Run Hospital,Nanjing Medical University,Jiangsu Province,Nanjing 211100,China;Medical Ethics Committee,Sir Run Run Hospital,Nanjing Medical University,Jiangsu Province,Nanjing 211100,China;College of Pharmacy,Nanjing Medical University,Jiangsu Province,Nanjing 211100,China)

机构地区：[1]南京医科大学附属逸夫医院国家药物临床试验机构,江苏南京211100 [2]南京医科大学附属逸夫医院医学伦理委员会,江苏南京211100 [3]南京医科大学药学院,江苏南京211100

出　　处：《中国当代医药》2022年第18期141-144,共4页China Modern Medicine

摘　　要：自2015年药品监管制度与药品审评审批机制改革以来,国内药物临床试验水平迅速发展,我国医药创新产业与全球创新产业链不断融合。全球创新药物引进国内速度不断加快的同时,国产新药也在逐步走向世界。新修订的《药品管理法(2019)》和《药品注册管理办法(2020)》进一步激励了我国的创新药物研发,开展药物临床试验研究成为当前创新药物研发的主要趋势。然而越来越多的药物临床试验研究涉及人类遗传资源的采集、利用、对外提供等事宜,因此加强人类遗传资源管理将成为关乎国家安全的重要内容。本文通过分析南京医科大学附属逸夫医院药物临床试验开始前、过程中及结束后等全过程中人类遗传资源管理的现状,对人类遗传资源管理的职责分工、组织培训、质量管理体系及信息化管理流程等方面提出建议,进一步提高药物临床试验的质量。Since the reform of Drug Regulatory System in 2015 as well as the Drug Review and Approval System,the level of domestic drug clinical trials has promoted rapidly and China′s pharmaceutical innovation industry has been continuously integrated with the chain of global innovation industry.As the import of global innovative drugs being promoted,domestic new drugs are also gradually going to the world.The newly revised Drug Administration Law(2019)and Drug Registration Administration Measures(2020)have further stimulated the innovative drugs research and development with drug clinical trials in China,which becomes the major development trend.However,an increasing number of drug clinical trials are involved in the collection,utilization,export and etc.of human genetic resources.Therefore,strengthening the management of human genetic resources is vital to national security.In this paper,analyzed the current situation of human genetic resources management during the whole process including the beginning,ongoing and ending of drug clinical trials in Sir Run Run Hospital,Nanjing Medical University.The corresponding suggestions covering the division of responsibility,organization and training,quality management system and the information management process of human genetic resources management,in order to further improve the quality of drug clinical trials.

关 键 词：创新药物研发 人类遗传资源 国家安全 药物临床试验 

分 类 号：R-331[医药卫生]