Welcome to the second biannual Cell and Gene Therapy Global 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 legislation 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. 

In this report, we see that year-over-year, non-genetically modified cell therapies continue to make up the majority of all approved products (68%). However, the pipeline for genetically modified cell therapies has grown to include 1,161 therapies in development, compared to 866 non-genetically modified cell therapies and 933 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 the ICH Reflection paper on International Harmonization on RWE and Netcord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration. 

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