Welcome to the first Cell and Gene Therapy Regulatory Report from ISCT and Citeline. This report provides a global overview of the cell and gene therapy regulatory landscape, including pipeline, late stage (Phase III and pre-registration), and approved products. It covers Cell, Genetically Modified Cell, and Gene Therapies. 

Over the last few years, the regulatory agencies have been updating legislations and frameworks to keep up with the rapidly advancing cell and gene therapy space. As a result, ISCT and Citeline have collaborated to highlight some of these changes and offer commentary on the updates and their effects. 

This report shows that year over year, cell therapies continue to make up the majority of all approved products (71%). However, the pipeline for genetically modified cell therapies has grown to include 1,150 therapies in development, compared to 839 non genetically modified cell therapies and 920 gene therapies. 

Meanwhile, ISCT continues to track regulatory changes and events and provide comments on Key Global Legislative/Framework Changes as well as international standards including WHO’s approach towards the development of a global regulatory framework for cell and gene therapy products and FACT JACIE International Standards for Hematopoietic Cellular Therapy Product.

For the full report, please download the PDF version at the top of this page.