Regulatory and operational framework for Chimeric Antigen Receptor T cell therapy in Brazil

Abstract

Objective: Provides an overview of Brazil’s CAR-T regulatory structure, emphasizing post-authorization surveillance, clinical approval, manufacturing, and product release. Methods: Good Manufacturing Practice, ethics, biosafety, quality control, traceability, pharmacovigilance, and international harmonization are among the national and ANVISA laws governing advanced therapeutic products reviewed in this work. Results: Brazilian CAR-T manufacturing requires GMP-certified facilities, trained workers, and proven processes in addition to quality control and environmental monitoring. ANVISA and CONEP approval, as well as CTNBio authorization for GMOs, are necessary for clinical investigations. Sterility, endotoxin levels, mycoplasma presence, viability, potency, vector copy number, transduction efficiency, identification, and traceability are some of the variables that affect the product release process. Pharmacovigilance, safety reporting, inspections, and manufacturing management are among the duties that follow approval. Conclusion: Brazil has established a comprehensive regulatory framework for CAR-T therapy that accounts for both regional operational requirements and international norms. Expanding safe, long-term access to cell and gene therapies would require bolstering national manufacturing capacity and the development of flexible regulatory frameworks.