The Standards are the cornerstone of the JACIE certification program. FACT-JACIE Standards are evidence-based Standards set by international teams of experts working within the field of cellular therapies. The Standards are based upon published medical evidence whenever possible. If no published data is available, the Standards are based on accepted scientific theory. The development process includes a period for public review and comment, a legal review, and an approval by the respective FACT and JACIE Boards.
The Standards currently apply to Haematopoietic Progenitor Cells (HPC), nucleated cells or mononuclear cells from any haematopoietic tissue source, as well as to Immune Effector Cells (IEC) and genetically modified cells.
FACT-JACIE International Standards
FACT and JACIE have released the 9th Edition HCT Standards and 3rd Edition IEC Standards, along with their updated manuals (29 October 2025). Access the full set of updated resources below:
