Global Governance of Cell and Gene Therapy and China’s Institutional Transformation

CGT (cell and gene therapy), as a frontier technology in biomedicine, is reshaping global healthcare systems while simultaneously challenging existing regulatory frameworks with its high-risk, high-value characteristics. A comparative view of representative jurisdictions shows that risk stratification and expedited pathways, complemented by instruments such as hospital exemptions, conditional approvals, and international recognition, have become pivotal in achieving a dynamic balance between unified regulation and differentiated exceptions. China has established a preliminary whole-process governance framework for CGT, yet continues to face structural constraints including insufficient legal hierarchy, fragmented regulatory pathways, lagging reimbursement mechanisms, and inconsistent ethical oversight. Drawing on bibliometric evidence and comparative regulatory analysis, this article argues for the adoption of dedicated legislation and tiered standards to connect the entire chain from research and development to clinical application, product registration, and post-marketing surveillance; the integration of embedded ethics, long-term follow-up, and real-world evidence to reinforce safety baselines; the use of differentiated review, early engagement, and regulatory sandboxes to accelerate translation; and active participation in international recognition and standard-setting to embed Chinese practices into global governance networks. Together, these measures can support China’s strategic transition from a regulatory follower to a regulatory shaper in the global CGT landscape.

CSTR: 32200.14.cjcb.2026.01.0003