Regulatory framework of human germline and heritable genome editing in China: a comparison with the United States and the United Kingdom.

Abstract

Genome editing technology is rapidly advancing and has generated significant controversy, particularly in the field of human heritable genome editing, while also presenting vast potential applications. Following the He Jiankui incident in 2018, there was a global call to reinforce the regulatory frameworks governing human germline and heritable genome editing. China's existing regulatory framework for human genome editing has improved with several laws enacted and updated, but there are shortcomings. These include overlapping responsibilities of multiple governing agencies and limited involvement of patient groups and the public in the legislative process. By drawing insights from regulatory agencies, legislation, and multigroup participation from abroad, especially in the United Kingdom and the United States, we can compare the differences between China and foreign countries and help China enhance its regulatory framework based on international practices. This article proposes recommendations for enhancing China's regulatory framework, such as clarifying the responsibilities of agencies, updating policies in a timely manner, strengthening bioethics education and training, and emphasizing the need for a forward-looking, balanced, meticulous, and adaptable regulatory approach.