Global Regulatory Report on Cell and Gene Therapy

This document is a global regulatory report on cell and gene therapy, published in June 2023 by ISCT and Citeline. It provides an overview of the regulatory landscape for cell and gene therapies, including details on pipeline products, recent approvals, and regulatory reviews. The report highlights the ongoing updates in legislation and frameworks by regulatory agencies to adapt to advancements in the field. It presents data showing that cell therapies constitute 71% of all approved products, with a growing pipeline of genetically modified cell therapies totaling 1,150 in development. The report also tracks key global legislative changes and international standards relevant to the sector, including the WHO's approach to a global regulatory framework and FACT-JACIE standards for hematopoietic cellular therapy products. The authors include experts from ISCT and Citeline, who contribute to the understanding of the evolving regulatory environment for these innovative therapies.