TY - JOUR AU - Kondo, Andrea Tiemi AU - Ribeiro, Andreza Alice Feitosa PY - 2022/04/24 Y2 - 2024/03/28 TI - Regulatory considerations for Cellular Therapy JF - JOURNAL OF BONE MARROW TRANSPLANTATION AND CELLULAR THERAPY JA - jbmtct VL - 3 IS - 1 SE - Original article DO - 10.46765/2675-374X.2022v3n1p166 UR - https://www.jbmtct.com.br/seer/index.php/jbmtct/article/view/166 SP - 166 AB - <p>Advanced therapy products can be an alternative treatment for several disease. Manufacturing steps and product release are critical points to avoid unsafe use of products. Quality controls tests, manufacturing practice, safety testing and efficacy trials need to be properly accessed before releasing to patients.&nbsp; Regulatory system for cell therapy products determines guidelines for production, clinical trials and registration, considering risk-benefit ratios. This article aims to discuss main aspects of National Regulatory for advanced therapy products.</p> ER -