Tuula Rinala
Director, Quality of Care and Advocacy
EBMT, European Society for Blood and Marrow Transplantation
Barcelona, Spain
As of 2 February 2026, the FACT-JACIE International Standards for Immune Effector Cells, Third Edition (IEC 3.1), are in effect — bringing with them a formal, dedicated certification pathway for programmes delivering IEC therapies outside of a transplant setting.
Background
The rapid clinical expansion of immune effector cell therapies — including CAR-T cells, CAR-NK cells, tumour-infiltrating lymphocytes (TILs), and dendritic cell vaccines — has created urgent demand for a quality and accreditation framework that reflects the distinct operational realities of IEC programmes. Historically, IEC-related standards existed within the broader FACT-JACIE Haematopoietic Cellular Therapy (HCT) framework. The 3rd Edition IEC Standards, developed over three years by an international expert committee and published on 28 October 2025, represent the first co-publication of a standalone IEC standards document by both FACT and JACIE.
These IEC Standards entered into effect on 2 February 2026 (Version 3.1, revised 17 December 2025).
Two Distinct Certification Pathways
Following the co-publication of the IEC Standards JACIE certification now operates via two formally defined pathways:
The HCT Pathway applies to transplant programmes that may also administer IECs. These centres are assessed against the FACT-JACIE International Standards for Haematopoietic Cellular Therapy, 9th Edition (9.1), which incorporate IEC-specific requirements alongside transplant standards.
The IEC Pathway is designed exclusively for programmes delivering immune effector cell therapies outside of a transplant setting. Target programmes include oncology and autoimmune disease units, clinical trials facilities, and standalone IEC facilities. These programmes are assessed against the FACT-JACIE IEC Standards, 3rd Edition (3.1), which exclude requirements specific to haematopoietic cell transplantation.
Scope and Product Coverage
The 3rd Edition defines immune effector cells broadly as cells — whether in vitro modified or not — that have differentiated into a form capable of modulating or effecting a specific immune response. The scope encompasses T cells, TILs, NK cells, dendritic cells, and mesenchymal stromal cells, with final products including CAR-T cells, CAR-NK cells, and dendritic cell vaccines. Donor lymphocyte infusions (DLI) fall outside this definition for certification purposes.
Where IEC products are manufactured by a third-party facility, JACIE inspectors assess the programme’s responsibilities — including formal agreements, manufacturer interactions, oversight processes, and product-specific handling activities — rather than the manufacturing facility itself.
Key Changes and New Requirements
The 3rd Edition introduces a number of substantive updates relevant to ISCT members:
- Minimum activity thresholds for IEC certification (new). Programmes seeking initial certification under the IEC pathway must demonstrate treatment of at least five (5) new patients with immune effector cell therapy prior to certification, with the same threshold applying annually thereafter. This is higher than the three-patient minimum introduced in the concurrent HCT 9th Edition for IEC activity within transplant programmes. Any programmes interested in JACIE Certification but potentially falling short of the minimum activity requirement are advised to contact JACIE to discuss their individual circumstances.
- Strengthened quality management requirements. Controlled documents now explicitly include manuals. Required elements of audit plans and audit reports — including review and approval responsibilities — are formally listed. Requirements for competency and validation review and approval are also clarified.
- Enhanced clinical standards. Updates include clarified requirements for donor consent (to include alternative collection methods), refined pregnancy and haemoglobinopathy testing requirements, expanded guidance on management of IEC-related complications (including lymphodepletion, immunomodulatory agents, prolonged cytopenia, and renal support), and a recommendation to incorporate psychosocial care in long-term follow-up.
- Alignment with ISBT 128 and registry reporting. Definitions have been updated to align with current ICCBBA terminology, and data submission form names have been updated to reflect current EBMT requirements.
- Pathway to non-doctoral Processing Facility Director. Guidance is now provided for individuals without a doctoral-level degree to serve as Processing Facility Director, supporting greater workforce flexibility.
- New audit requirements. Clinical, Collection, and Processing Standards now include formal audit requirements (Standards 4.8.4–4.8.6), underscoring JACIE’s continued emphasis on systematic self-assessment.
Certification Process for IEC Programmes
Programmes seeking to add IEC certification to an existing JACIE certification have two routes available. IEC scope can be incorporated at the point of initial certification or recertification, in which case the Clinical inspector assesses both HCT and IEC activities together. Alternatively, a currently certified centre wishing to expand its scope can request a focused reinspection — typically lasting up to one day with two inspectors.
Programmes applying for a ‘standalone’ IEC Certification as outlined above, will be assigned inspection teams based on the application form submitted by the Programme and the scope of the certification. For example, if the IEC application only includes Clinical and Collection facilities, the inspection team will cover these scopes and the quality management.
The JACIE certification cycle remains four years for all certified programmes.
Significance for the Field
The formalisation of a dedicated IEC pathway under co-developed FACT-JACIE standards is a significant development for programmes operating at the intersection of advanced cellular therapy and quality assurance. By providing a route to certification that does not require transplant programme infrastructure, JACIE opens formal certification to the growing number of oncology and autoimmune disease centres administering CAR-T and other IEC therapies. This is particularly relevant as payers and regulatory authorities in several European jurisdictions increasingly regard JACIE certification as a prerequisite for treatment authorisation and reimbursement.
ISCT members involved in IEC programme development, quality management, or policy are encouraged to familiarise themselves with the new standards and accreditation manual, both available free on the JACIE website.
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