Walking a fine line: deconstructing China’s regulatory strategy for human genome editing

Abstract The rapid advancement of gene editing technologies, particularly the widespread application of CRISPR in clinical and scientific research, has made effective regulation of these technologies a pressing global concern. This study conducts a comprehensive review of the current legal framework and regulatory environment governing human gene editing in China. It reveals critical shortcomings in the existing system, including fragmented oversight, an unclear allocation of legal responsibilities, insufficient capacity within ethical review committees, and inadequate mechanisms for ongoing and post-procedural supervision. To remedy this, this article advocates for the creation of a unified “ Human Genome Editing Act ” by incorporating global regulatory standards and taking into account China’s unique situation, as well as defining clear legal obligations, strengthening ethics committees’ expertise, and setting up a comprehensive regulatory framework. By constructing a scientific, systematic, and practical regulatory framework, China can safeguard academic freedom and effectively prevent technological abuse, thereby promoting the responsible development of human gene editing technologies.