Abstract: Objective To investigate the way cell therapy products are currently regulated globally and to offer evidence-based recommendations for optimizing China's post-marketing long-term safety surveillance framework. Methods Related literature about and guidelines for the regulation of cell therapy products in the United States, the European Union, Japan, South Korea, and China were summarized. Based on the realities in China, feasible optimization strategies for long-term safety surveillance of cell therapy products were proposed. Results As of March 2026, eight chimeric antigen receptor T-cell (CAR-T) therapies and one stem cell product had been approved for marketing in China, compared with 49 cell and gene therapy products by the U.S. FDA and 28 cell therapy products by the European Medicines Agency (EMA). A comparative analysis of the current regulatory frameworks revealed that the United States, the European Union, Japan, and the Republic of Korea had all established specialized regulatory bodies and risk-based management systems, characterized by well-defined regulatory mechanisms and detailed guidelines. China had implemented a “dual-track” regulatory model. Conclusion We recommend a four-pronged strategic framework for optimizing China's post-marketing long-term safety surveillance system by updating the top legislation and establishing a risk-stratified monitoring system, reinforcing the dual-track responsibilities of marketing authorization holders (MAHs) and medical institutions, boosting an AI-empowered precision pharmacovigilance paradigm, and enhancing ethical governance frameworks for long-term follow-up informed consent and patient privacy protection. China needs to consolidate its long-term safety surveillance infrastructure for cell therapy products.

Key words: Cell Therapy Products, Adverse Drug Reaction, Post-Marketing Surveillance, Pharmacovigilance, Safety Surveillance