ISCT Global Regulatory Report

Developed by ISCT in partnership with Citeline, the Global Regulatory Report provides an overview of the cell and gene therapy regulatory landscape, including pipeline, late-stage (Phase III and pre-registration), approved products, covering cell, genetically modified cell and gene therapies.

SECOND GLOBAL REGULATORY REPORT: 2023 Q3-Q4

COMING SOON

Highlights:

  • 2960 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

FIRST GLOBAL REGULATORY REPORT: 2023 Q1-Q2

Highlights:

  • 87 cell and gene therapies approved globally, and 71% of them are non-genetically modified cell products.
  • 81 cell and gene therapies under the late development stages (Phase III or pre-registration)
  • Key Global Legislative/Framework changes by EU Commission, US FDA, Health Canada, TGA, NZ Ministry of Health, WHO
  • Carvykti®, received TGA Approval for the treatment of people with multiple Myeloma
  • Vyjuvek™, received FDA BLA Approval for the treatment of wounds in patients with Dystrophic Epidermolysis Bullosa

READ THE FULL REPORT

The International Society for Cell & Gene Therapy (ISCT) is a global society of clinicians, regulators, researchers, technologists, and industry partners with a shared vision to translate cell and gene therapy into safe and effective therapies to improve patients' lives worldwide.

ISCT is the global leader focused on pre-clinical and translational aspects of developing cell and gene-based therapeutics, thereby advancing scientific research into innovative treatments for patients. ISCT offers a unique collaborative environment that addresses three key areas of translation: Academia, Regulatory, and Commercialization. Through strong relationships with global regulatory agencies, academic institutions, and industry partners, ISCT drives the advancement of research into a standard of care.

Comprised of over 3,000 cell and gene therapy experts across five geographic regions and representation from over 60 countries, ISCT members are part of a global community of peers, thought leaders, and organizations invested in cell and gene therapy translation. For more information about the organization, visit ISCT.

Citeline (formerly Pharma Intelligence) powers a full suite of complementary business intelligence offerings to meet the evolving needs of life science professionals to accelerate the connection of treatments to patients and patients to treatments. These patient-focused solutions and services deliver and analyze data used to drive clinical, commercial, and regulatory related-decisions and create real-world opportunities for growth.

Our global teams of analysts, journalists and consultants keep their fingers on the pulse of the pharmaceutical, biomedical and medtech industries, covering it all with expert insights: key diseases, clinical trials, drug R&D and approvals, market forecasts and more. For more information on one of the world’s most trusted life science partners, visit Citeline.