Abstract：In order to strengthen the management of human genetic resources in China and better adapt to the development 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 international 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 regulations,unclear regulatory responsibilities,and lack of initiative in applicants'declaration.Therefore,the relevant departments still need to further improve the relevant laws and regulations,clarify supervision responsibilities,increase publicity and guidance,and encourage applicants to declare actively.
侯春花;田丽娟. 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[J]. 中国当代医药, 2018, 25(27): 146-148.
HOU Chun-hua;TIAN Li-juan. Analysis of Human Genetic Resource Administration of China in international cooperative clinical trial. 中国当代医药, 2018, 25(27): 146-148.
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