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[关于使用活体转基因生物进行研究和开发实验的批准制度的介绍]

Min-Ah Lee¹, Yoonju Shin¹, Jeonghwa Shin¹

¹질병관리청 진단분석국 생물안전평가과.

Jugan geon-gang gwa jilbyeong

|December 3, 2025

概括

韩国疾病控制和预防局 (KDCA) 在2023年11月更新了对转基因生物 (GMO) 的规定. 这些变化通过豁免某些耐药性基因和简化申请提交来简化研究.

科学领域:

生物技术是生物技术.
监管科学监管科学
遗传学是一个遗传学.

背景情况:

韩国现有的转基因生物 (GMO) 监管框架要求对各种研究和开发活动进行国家批准.
行政负担和漫长的审批流程可能会阻碍转基因生物研究领域的科学进步.

研究的目的:

修订和改进国家对活体转基因生物的研究和开发的批准制度.
减少对转基因生物进行研究的科学家的行政负担,提高研究效率.

主要方法:

修订了"关于跨境移动等的公开通知". 生物修饰生物法案"由韩国疾病控制和预防局 (KDCA) 颁布.
在药物耐药性基因列表中,将尼奥米辛和斯佩克提诺米辛耐药性基因列入免于国家批准的药物耐药性基因列表.
允许通过电子或纸质文件提交批准申请.

主要成果:

某些药物耐药基因 (neomycin,spectinomycin) 现在不需要国家批准.
研究人员可以使用电子或纸质格式提交申请,提供更大的灵活性.
预计将减少参与转基因生物开发的研究人员的行政工作量.

结论:

修订后的法规旨在简化韩国转基因生物研究和开发的批准程序.
预计这些监管改进将促进生物技术领域的研究效率和创新.
肯德基生物监管局仍然致力于确保生物安全,同时通过持续的监管更新促进转基因生物研究的进步.

关键词:

抗药性基因是药物耐药性的基因.活着的改造生物活着的改造生物国家批准国家批准.研究和开发使用研究和开发使用.

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