{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,21]],"date-time":"2026-09-21T05:04:09Z","timestamp":1789967049994,"version":"4.0.1"},"reference-count":234,"publisher":"MDPI AG","issue":"4","license":[{"start":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T00:00:00Z","timestamp":1789516800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["BioTech"],"abstract":"<jats:p>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\u2019s 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.<\/jats:p>","DOI":"10.3390\/biotech15040079","type":"journal-article","created":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T16:07:29Z","timestamp":1789574849000},"page":"79","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Regulatory Convergence in Cell and Gene Therapy: Harmonizing Quality, CMC, and Approval Pathways Across the FDA, EMA, PMDA, and Emerging Markets"],"prefix":"10.3390","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3149-7764","authenticated-orcid":false,"given":"Nagendra","family":"Verma","sequence":"first","affiliation":[{"name":"Applied Education in the MedTech Industry, St. Cloud State University, Brooklyn Park, MN 55445, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Swati","family":"Arora","sequence":"additional","affiliation":[{"name":"Department of Chemistry, University of Pittsburgh, 219 Parkman Ave, Pittsburgh, PA 15260, USA"},{"name":"Eli Lilly and Company, Indianapolis, IN 46221, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,9,16]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"609","DOI":"10.1080\/17460751.2025.2580888","article-title":"Regulatory challenges and opportunities in cell-based therapies: Overcoming barriers to advancement and patient care","volume":"20","author":"Musyuni","year":"2025","journal-title":"Regen. 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