ISCT Global Regulatory Report - June 22, 2023



Highlights of the report include:
  • 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




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.

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