细胞与基因治疗的监管趋同：协调FDA、EMA、PMDA及新兴市场的质量、CMC与审批路径

Cell and gene therapies (CGTs) have progressed from proof of concept to an established commercial pipeline, yet global translation remains constrained by fragmented regulatory frameworks; heterogeneous Chemistry, Manufacturing, and Controls (CMC) requirements; and divergent approval pathways. This narrative review compares CGT quality, CMC, and approval-pathway regulation across the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and Japan's Pharmaceuticals and Medical Devices Agency (PMDA), together with five emerging-market agencies: Brazil, Russia, India, China, and Mexico (BRIC-M), current to June 2026. Four convergence gaps recur across all eight jurisdictions: unstandardized potency assay validation, inconsistent post-change comparability expectations, uneven ICH guideline implementation, and divergent evidentiary thresholds for small-population trials. Convergence readiness varies sharply within the emerging-market group, from ICH Regulatory Membership and internationally benchmarked CMC guidance in China and Brazil to reference-country reliance in Mexico and observer status in Russia and India. On this basis, we propose the Global CGT Regulatory Convergence Framework (GCRC-F), a reference architecture of four independently adoptable pillars: (i) Unified CMC Standards, (ii) a Data Harmonization Layer for long-term follow-up and real-world evidence, (iii) an Adaptive Approval Layer linking accelerated designations across agencies, and (iv) a Manufacturing Standardization Layer that is built on existing regulatory precedents rather than novel instruments, with participation tiered by demonstrated regulatory-science maturity. The framework is offered as a structured proposal for discussion; it has not been evaluated by regulators or industry stakeholders, and its feasibility remains to be tested through the consultation and case-study methods identified.