Comparative analysis of mesenchymal stromal cells therapy regulatory models worldwide and optimization of China's regulatory pathway.

Abstract

This study compares mesenchymal stromal cell therapy regulatory frameworks in the United States, European Union, Japan, Canada, South Korea, Australia and China using the World Health Organization and International Society for Cell & Gene Therapy guidance as benchmarks. This study analyzes a framework comprising five dimensions: product classification, regulatory oversight, ethical governance, risk control and expedited access. Across jurisdictions, common patterns include risk‑based classification, lifecycle oversight, robust ethical review and transparency, Good Manufacturing Practice quality systems and evidence‑linked acceleration pathways. China's dual‑track system and recent guidelines reflect progress, but gaps remain in boundary definition between research and therapy, unified oversight, public registration, nationwide quality standards, long‑term follow‑up and enforcement. We recommend codifying clear risk tiers, creating a single regulatory window with joint authority, integrating ethics and registry systems, issuing national standards for facilities and traceability, enforcing time‑bound confirmatory obligations and expanding international cooperation to align China's framework with global best practices.