Stem Cell-based Medicinal Products: Regulatory Perspectives


Ozdil D., AYDIN H. M.

ADVANCED SURFACES FOR STEM CELL RESEARCH, pp.323-342, 2017 (Journal Indexed in SCI) identifier

  • Publication Type: Article / Article
  • Volume:
  • Publication Date: 2017
  • Title of Journal : ADVANCED SURFACES FOR STEM CELL RESEARCH
  • Page Numbers: pp.323-342

Abstract

Regulatory control and strictures are fundamentally intended to ensure a balance between the risks and benefits of medical products. It is equally important, however, that regulatory systems allow for innovative advancements in medical technologies whilst ensuring public safety. The legal infrastructure governing the field of cell-based medicinal products has been developed in order to prevent, correct and account for all non-conforming actions, potential risks and ethical concerns related to the clinical use of such products. Collectively, the rules and regulations set by regulatory authorities impact all quality, clinical and non-clinical issues related to the final product. It is crucial for all relevant professionals to familiarize themselves with the standards regulating the stem cell therapy field. A comprehensive and stable regulatory framework is critical for enabling and monitoring advancements. This chapter aims to provide an overview of some global and regional regulatory perspectives regarding stem cell-based medicinal products.