基因组编辑产品的安全管理

Regulatory framework of genome-edited products – a review

摘要:

基因组编辑技术是指利用特异性核酸酶的定点剪切活性与细胞内源DNA损伤修复活性，在基因组水平上对目的核酸序列或单个核苷酸进行定点修饰的基因工程技术，该技术可以对生物体基因组进行精确敲除、插入、单碱基突变或置换等编辑。目前，基因组编辑技术具有精确性、高效性及易操作性，应用范围日益扩大。文中简要概述了3种主要的基因组编辑技术工具及基因组编辑类型，介绍了美国、欧盟等国家和地区对基因组编辑产品的监管体制。同时，基于我国对转基因产品的安全管理原则与体系，初步提出了基因组编辑产品的安全管理思路。根据中间材料或产品中是否含有外源编辑酶蛋白基因成分对基因组编辑产品进行分类管理，含有外源编辑酶的材料应按现有转基因安全管理办法进行管理；中间材料或产品中不含有Cas9等编辑酶的材料应根据被编辑位点的特征进行具体分类管理。

Abstract:

Genome editing is a genetic engineering technique that uses site-directed cleavage activity of specific artificial nucleases and endogenous DNA damage repair activity to generate insertions, deletions or substitutions in the targeted genomic loci. As the accuracy and efficiency of genome editing is improving and the operation is simple, the application of genome editing is expanding. This article provides an overview of the three major genome editing technologies and genome editing types, and the regulatory frameworks for genome-edited products were summarized in the United States, the European Union, and other countries. At the same time, based on the Chinese safety management principles and systems for genetically modified organisms (GMOs), the authors proposed a regulatory framework for genome-edited products. Genome-edited products should first be classified according to whether containing exogenous genetic components such as Cas9 editing enzymes or not. They should be regulated as traditional genetically modified organisms if they do. Otherwise, the regulation of genome-edited products depends on targeted modifications.