Yan Yuanyuan, Zhu Jinjie, Xie Chuanxiao, Liu Changlin
Institute of Crop Science, Chinese Academy of Agricultural Sciences, Beijing 100081, China.
Maize Research Institute, Sichuan Agricultural University, Chengdu 610000, Sichuan, China.
Sheng Wu Gong Cheng Xue Bao. 2019 Jun 25;35(6):921-930. doi: 10.13345/j.cjb.180418.
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.
基因组编辑是一种基因工程技术，它利用特定人工核酸酶的位点定向切割活性和内源性DNA损伤修复活性，在目标基因组位点产生插入、缺失或替换。随着基因组编辑的准确性和效率不断提高且操作简便，其应用正在不断扩展。本文概述了三种主要的基因组编辑技术和基因组编辑类型，并总结了美国、欧盟和其他国家针对基因组编辑产品的监管框架。同时，基于中国对转基因生物的安全管理原则和体系，作者提出了针对基因组编辑产品的监管框架。基因组编辑产品应首先根据是否含有如Cas9编辑酶等外源遗传成分进行分类。如果含有，则应作为传统转基因生物进行监管。否则，基因组编辑产品的监管取决于靶向修饰。
