As a culmination of three years of work, the publication of FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration, Ninth Edition (HCT 9) and the FACT-JACIE International Standards for Immune Effector Cells, Third Edition (IEC 3) is a true milestone in the fields of HCT and Cellular Therapies.
These updated Standards are a concrete example of the ongoing commitment to promoting quality medical and laboratory practice in haematopoietic progenitor cell transplantation and cellular therapies by both organisations. As the field of cellular therapy continues to evolve rapidly, these new editions capture and reflect the latest advances and best practices, ensuring they remain relevant and useful resources for programmes worldwide. Never has been the commitment to quality been more important in ensuring the safety of the patients receiving these treatments, quality of the products administered and the safety of the staff involved in the collection, storage and administration of these products.
The development of these two sets of Standards has been a comprehensive undertaking, requiring dedication, expertise, and countless hours of collaborative effort across the globe. We want to extend our heartfelt thanks to the Standards Steering Committee for their strategic leadership and oversight throughout this extensive revision process. Their vision and guidance have been instrumental in bringing these updated Standards to fruition. There has been lively discussions at every stage including the review of the public comments – more than 1,000 of them – and for the first time, the comments, decisions taken and the rational for those decisions, will be published and shared with our stakeholders after the Standards documents have been published.
We are equally grateful to the Sub-Committee Chairs and all the Sub-Committee members, who led the detailed review and revision work across the Clinical, Collection, Processing, IEC, and the Quality Management domains. Their expertise and commitment to excellence have ensured that every aspect of the Standards reflects current best practice and the experience in the field. It is the clinical and laboratory expertise, thoughtful contributions, and rigorous review that have been essential to developing Standards that are both comprehensive and practical.
The Standards will be published at the end of October with the accompanying Standards Manuals that as before, will explain the intent of the Standards, include examples of the evidence required by the inspectors at the time of the inspections.
These Standards will continue to serve as the cornerstone of JACIE and FACT programs worldwide, helping cellular therapy programs maintain the highest standards of patient care and laboratory practice.
There will be a JACIE webinar to highlight the key changes and updates in the 9th Edition of HCT and 3rd Edition IEC Standards on 29th November 2025 at 3 pm CET.