Journal of Stem Cell Research & Therapy

Cell therapy regulatory challenge in Saudi Arabia

7^th International Conference and Expo on Cell and Stem Cell Research

June 28, 2023 | Webinar

Mashael Khalid AlMirzam

Saudi Food and Drug Authority, Saudi Arabia

Posters & Accepted Abstracts: J Stem Cell Res Ther

Abstract:

Cell therapy can be either stem cell based or adult cell based with different immunophenotypic profiles, isolation techniques, mechanisms of action, and regulatory levels. In 1984, Saudi Arabia was the first Arab state to perform hematopoietic stem cell transplantation (HSCT). Currently, an approximate total of 500 allogeneic transplants are performed annually. The sector since then has been buoyed by early successes that are driving more development and investment in the field providing patients with promising therapeutic benefits in different disease areas. While some Cell based products such as CAR T Cell have been well studied and are approaching manufacturing and regulatory maturation or standardization, the field continues to rapidly evolve and generate new quality and regulatory challenges. Regulation of cellular therapies falls under different pathways depending on processing, intended use, country of collection and manufacture. Here we try to provide a high level insight on the common challenges associated with cell therapy product classification and phase appropriate control strategies for investigational products (IND). We will also address the main challenges faced across the unique and complex regulatory landscape in Saudi Arabia.