国际合作临床试验中人类遗传资源管理发展历程及现状分析  

Analysis of Human Genetic Resource Administration of China in international cooperative clinical trial

作　　者：侯春花 田丽娟[1] HOU Chun-hua;TIAN Li-juan(School of Business Administration,Shenyang Pharmaceutical University,Liaoning Province,Shenyang 110016,China)

机构地区：[1]沈阳药科大学工商管理学院,辽宁沈阳110016

出　　处：《中国当代医药》2018年第27期146-148,共3页China Modern Medicine

摘　　要：为加强我国人类遗传资源的管理,更好地适应我国临床试验的发展,本文对我国国际合作临床试验中人类遗传资源管理发展历程、实施效果和面临的挑战进行分析,得出我国国际合作临床试验中,人类遗传资源管理逐渐规范、人类遗传资源合理利用和保护逐渐加强,临床试验规范性逐渐提高。但仍然存在相关法规不够完善、监管职责不清、申请人申报缺乏主动性等问题,因此相关部门仍需进一步完善相关法规、明确监督职责、加大宣传指导,鼓励申请人积极申报。In order to strengthen the management of human genetic resources in China and better adapt to the devel- opment of clinical trials in China, this paper analyzes the development process, implementation effect and challenges of human genetic resources management in international cooperative clinical trials in China. It is concluded that in the in- ternational cooperative clinical trials in China, the management of human genetic resources is gradually standardized, the rational utilization and protection of human genetic resources are gradually strengthened, and the standardization of clinical trials is gradually improved. However, there are still some problems, such as imperfect relevant laws and regu- lations, unclear regulatory responsibilities, and lack of initiative in applicants＇declaration. Therefore, the relevant de- partments still need to further improve the relevant laws and regulations, clarify supervision responsibilities, increase publicity and guidance, and encourage applieants To declare actively.

关 键 词：国际合作 临床试验 人类遗传资源 

分 类 号：R987[医药卫生—药品]