Open AccessRegulatory considerations for Cellular Therapy
Author(s) -
Andrea Tiemi Kondo,
Andreza Alice Feitosa Ribeiro
Publication year - 2022
Publication title -
journal of bone marrow transplantation and cellular therapy
Language(s) - English
Resource type - Journals
ISSN - 2675-374X
DOI - 10.46765/2675-374x.2022v3n1p166
Subject(s) - clinical trial , risk analysis (engineering) , product (mathematics) , good manufacturing practice , quality (philosophy) , intensive care medicine , production (economics) , medicine , business , operations management , engineering , regulatory affairs , economics , pathology , macroeconomics , philosophy , geometry , mathematics , epistemology
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. 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.