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| Analysis of Human Genetic Resource Administration of China in international cooperative clinical trial |
| HOU Chun-hua TIAN Li-juan▲ |
| School of Business Administration,Shenyang Pharmaceutical University,Liaoning Province,Shenyang 110016,China |
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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.
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| [1] |
苏月，何蕊，沈建忠，等.加强我国人类遗传资源保护和利用[J].中国临床实验室管理电子杂志，2017，5（1）：9-11.
|
| [2] |
中华人民共和国国务院办公厅.人类遗传资源管理暂行办法.国办发〔1998〕36 号[EB/OL].http：//www.most.gov.cn/mostinfo/xinxifenlei/fgzc/xzfg/200811/t20081129_65698.htm
|
| [3] |
封展旗，杨同卫.“基因争夺战”透析[J].山东医科大学学报（社会科学版），2000，（4）：8-9.
|
| [4] |
褚程俊，刘俊.人类遗传资源提取的跨国保护---基于哈佛大学在安徽基因研究项目的个案分析[J].法学，2002，（11）：60-66.
|
| [5] |
封展旗，杨同卫.保护中国人类遗传资源的思考[J].科技管理研究，2001，（4）：67-69.
|
| [6] |
中华人民共和国国务院办公厅.国务院对确需保留的行政审批项目设定行政许可的决定 （国务院令第412号）[EB/OL].http：//www.mofcom.gov.cn/aarticle/b/g/200408/20040800271457.html?1015685590=2687717843.
|
| [7] |
中华人民共和国科学技术部.《关于加强人类遗传资源保护管理工作的通知》[EB/OL].[2011-06-02]http：//www.most.gov.cn/fggw/zfwj/zfwj2011/201106/t20110616_87557.htm.
|
| [8] |
中华人民共和国科学技术部.科技部关于进一步加强人类遗传资源管理工作的通知[EB/OL].[2013-10-11].http：//www.most.gov.cn/mostinfo/xinxifenlei/fgzc/gfxwj/gfxwj2013/201310/t20131015_109772.htm.
|
| [9] |
中华人民共和国国务院办公厅.《国务院关于第六批取消和调整行政审批项目的决定》国发〔2012〕52号[EB/OL].http：//www.gov.cn/zwgk/2012-10/10/content_2240096.htm.
|
| [10] |
中华人民共和国科技部.关于发布《人类遗传资源采集、收集、买卖、出口、出境审批行政许可事项服务指南》的通知[EB/OL].[2016-11-03].http：//www.most.gov.cn/tztg/201507/t20150703_120547.htm.
|
| [11] |
中华人民共和国科技部.科技部办公厅关于优化人类遗传资源行政审批流程的通知[EB/OL].[2017-10-26].http//www.most.gov.cn/mostinfo/xinxifenlei/fgzc/gfxwj/gfxwj2017/201710/t20171027_135781.htm.
|
| [12] |
操秀英.人类遗传资源管理，助推新药临床试验GCP建设[N].科技日报，2016-03-24（003）.
|
| [13] |
钟皎，王丽萍.人类遗传资源管理在临床试验中的要求和推动作用[J]中国新药与临床杂志.2018，37（1）：21-23.
|
|
|
|
