Comparative analysis of advanced therapy regulatory frameworks in Latin America: perspectives from the ISCT South and Central America Legal and Regulatory Affairs Committee

Advanced therapies, including gene therapies, somatic cell therapies, and tissue-engineered products, pose distinctive regulatory challenges because of their scientific complexity, manufacturing variability, clinical uncertainty, and long-term safety considerations. Recent clinical advances have heightened the need for regulatory pathways capable of supporting safe, effective, and sustainable access. Across Latin America, regulatory approaches for these products have evolved unevenly, reflecting differences in legislative development, institutional capacity, and regulatory specialization among National Regulatory Authorities (NRAs). This study aimed to comparatively assess the regulatory development of advanced therapies in selected Latin American countries through the evaluation of key regulatory dimensions, including conceptual definitions, institutional organization, specialized technical oversight mechanisms, authorization pathways, manufacturing requirements, and accumulated regulatory experience. Argentina, Brazil, Chile, Colombia, Cuba, and Mexico were selected based on their regional relevance, recognition of their NRAs by the Pan American Health Organization (PAHO), and the availability of publicly accessible information on biological products and advanced therapies. A narrative comparative regulatory review was conducted using publicly available legal, institutional, and technical information. The analysis was informed by internationally recognized frameworks developed by the World Health Organization (WHO), the International Council for Harmonization (ICH), the European Medicines Agency (EMA), the United States Food and Drug Administration (FDA), and the Pharmaceutical Inspection Co-operation Scheme (PIC/S), with emphasis on risk-based oversight, traceability, Good Manufacturing Practice (GMP), pharmacovigilance, and life-cycle regulation. The analysis identified substantial regional asymmetries in regulatory definitions, institutional specialization, authorization pathways, manufacturing oversight, and implementation capacity. Brazil and Argentina have established the most structured frameworks specifically addressing advanced therapy products, whereas Colombia, Cuba, and Mexico continue to rely primarily on broader provisions applicable to biological products, transplantation activities, or tissue banking. Chile has moved toward a more specialized model through the adoption of Technical Standard No. 257. Differences were also observed in the regulation of stem cell-based products, non-industrial manufacturing models, and specialized oversight mechanisms. Overall, the regulatory landscape for advanced therapies in Latin America remains heterogeneous and continues to evolve. Greater regional convergence, proportionate risk-based approaches, and carefully designed reliance mechanisms may strengthen regulatory preparedness and oversight while supporting the safe and sustainable development of advanced therapies in the region.