Regulatory considerations for Cellular Therapy

Authors

  • Andrea Tiemi Kondo Hospital Israelita Albert Einstein
  • Andreza Alice Feitosa Ribeiro

DOI:

https://doi.org/10.46765/2675-374X.2022v3n1p166

Keywords:

Regulatory; advanced therapy products; registration; good manufacturing practice

Abstract

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.

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Published

04/24/2022

How to Cite

Kondo, A. T., & Ribeiro, A. A. F. (2022). Regulatory considerations for Cellular Therapy. JOURNAL OF BONE MARROW TRANSPLANTATION AND CELLULAR THERAPY, 3(1), 166. https://doi.org/10.46765/2675-374X.2022v3n1p166

Issue

Vol. 3 No. 1 (2022): JOURNAL OF BONE MARROW TRANSPLANTATION AND CELLULAR THERAPY

Section

Original article

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