Accreditation Statistics

As of May 2, 2024

Cellular Therapy Entities

  • Accredited: 262
  • Applicants: 30

Cord Blood Banks

  • Accredited: 48
  • Applicants: 10

 

Initial Accreditations

  • Abu Dhabi Stem Cell Center, Abu Dhabi, United Arab Emirates | Cellular Therapy Product Processing with Minimal Manipulation
  • CHN - Complexo Hospitalar de Niterói, Rio de Janeiro, Brazil | Adult and Pediatric Allogeneic and Autologous Hematopoietic Progenitor Cell Transplantation, Marrow and  Peripheral Blood Cellular Therapy Product Collection, and Cellular Therapy Product Processing with Minimal Manipulation

     

A complete list of accredited organizations can be found at https://accredited.factglobal.org/.

ISCT Releases Second Global Regulatory Report

Posted in :: 2024 Volume 2 :: Tuesday, April 9th, 2024

ISCT published its second Global Regulatory Report, which covers Quarter 3 and Quarter 4 of 2023. This report is developed by ISCT in partnership with Citeline, and provides an overview of the cell and gene therapy regulatory landscape, including pipeline, late-stage (Phase III and pre-registration), and approved products, covering cell, genetically modified cell, and gene therapies.

Highlights of the current report include:

  • 2,960 therapies in the global pipeline (2% increase from H1 2023)
  • 80 products are under regulatory review globally of which 71 products are in Phase III clinical trials
  • 96 products approved globally (9% increase from H1 2023)
  • 6 products received their first approvals globally including.
    • Elevydis (delandistrogene moxeparvovec-rokl)
    • Lantidra (donislecel)
    • Fucaso® (equecabtagene autoleucel)
    • CNCT19 (inaticabtagene autoleucel)
    • Casgevy™ (exagamglogene autotemcel)
    • Lyfgenia™ (lovotibeglogene autotemcel)
  • Key Global Legislative/Framework Changes by US FDA, EMA, ICH, and NZ Ministry of Environment

We encourage personnel at accredited programs to review the report to learn more about what occurred in late 2023 and what is to come.

Learn more and access the Global Regulatory Report