Cell And Gene Therapy Global Regulatory Report

By The International Society for Cell & Gene Therapy (ISCT), and Citeline, a norstella company

In this inaugural Cell and Gene Therapy Regulatory Report, brought to you by ISCT and Citeline, authors offer a worldwide perspective on the regulatory landscape surrounding cell and gene therapy. It encompasses pipeline insights, late-stage developments (Phase III and pre-registration), and approved products within the realms of Cell, Genetically Modified Cell, and Gene Therapies.

As the cell and gene therapy field continues its rapid advancement, regulatory agencies have been diligently updating their legislation and frameworks. In response to these dynamic changes, ISCT and Citeline joined forces to shed light on pivotal alterations and provide insightful commentary on their implications. Their report underscores a consistent trend in which cell therapies consistently constitute the majority of approved products (71%). However, an intriguing shift has occurred in the genetically modified cell therapy pipeline, now comprising a substantial 1,150 therapies under development, surpassing 839 non-genetically modified cell therapies and 920 gene therapies.

Meanwhile, ISCT remains committed to tracking regulatory shifts and noteworthy events. This includes commentary on Key Global Legislative/Framework Changes, as well as the interpretation of international standards such as the WHO's global regulatory framework for cell and gene therapy products and FACT JACIE International Standards for Hematopoietic Cellular Therapy Products.