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Standards review meeting chaired by Dr Nicole Prokopishyn, Chair of the Standards Committees in FACT and supported by Dr Phyllis Warkentin, Medical Director (FACT) and Dr Lynn Manson, Chair of the JACIE Committee.

FACT-JACIE Steering group met in Paris 4th of June 2023, to kick off the Standards review process for the 9th edition of FACT-JACIE Standards. Although the 8th Edition of FACT-JACIE Standards were implemented only at the end of 2021, the three-year review cycle means that the work on the next edition of Standards is starting already. 

It was a rare opportunity for FACT and JACIE Sub-Committee Chairs and the FACT-JACIE operational support for this project to spend time discussing the logistics and challenges for this latest review. The meeting was chaired by Dr Nicole Prokopishyn, Chair of the Standards Committees in FACT and supported by Dr. Phyllis Warkentin, Medical Director (FACT) and Dr. Lynn Manson, Chair of the JACIE Committee. We were also grateful for colleagues joining virtually despite the challenges with the time difference.

The Standards review process is co-ordinated by FACT (Foundation of Cellular Therapy), and the two organizations have a long history of collaborating on Haematopoietic Cellular Therapy Product Collection, Processing and Administration. As of 2023, JACIE will also join in on the review of the 3rd edition of the Standards for Immune Effector Cells.  As JACIE currently offers a pathway for Immune Effector Cells (IEC) accreditation for HSCT centres only, the development of a standalone IEC pathway is an important step reflecting the changes in the field.

The FACT-JACIE Standards are a set of evidence-based requirements developed by experts from the US and Europe working within the field of cellular therapy. These are consensus standards developed within committees that consist of clinicians, scientists, and quality experts covering the full patient and product pathway for hematopoietic stem cell transplantation and cellular therapies from donor selection to clinical care. In addition, the Standards review process will consult stakeholders, such as scientific societies and regulatory bodies, throughout the development process. 

The work in Sub-Committees will commence in September 2023 for the 9th edition, with a plan to submit the new draft for public consultation in June 2024. Following the public consultation, the sub-committees will review all the comments, and after the final approval in January 2025, additional documents and inspection materials will be prepared, and the Standards will be published in April 2025. The full implementation of the 9th Edition of Standards is expected in August 2025.

As truly global Standards, the review process is complex and the stakeholders are many. There are both operational and scientific considerations to take into account when the Standards are reviewed. The transplant programmes increasingly work in different models – ‘hub and spoke’, networks – which can complicate the inspection process and the interpretation of Standards and potentially require more explanation and examples in the Standards Manual to cover these different operational models. 

In the European context, the range of regulatory approaches at national level can be complex and JACIE regularly receives feedback on the Standards not aligning with the national laws or regulations.  However, ‘Applicable Law’ is specifically defined in the Standards as ‘Any local, national, or international statute, regulation, or other governmental law that is applicable to cellular therapy product collection, processing, and administration that is relevant to the location or activities of the Clinical Program, Collection Facility, or Processing Facility’ and the Standards are very specific where applicable law should be followed. 


Many of us have been also following the discussion on the SoHO (Substances of Human Origin) EU regulatory proposal. The Steering Committee will be considering any potential impact this new regulation may have on the Standards as part of the review process to ensure that the Standards reflect and are aligned with the EU regulatory framework. 


Lastly, there are common themes in the feedback the JACIE office receives from Centres and the inspectors alike with regard to the Standards. The sheer volume of the Standards is a challenge for everyone involved in the process. Similarly, the stakeholders often comment on the repetitive nature of the Standards not just between the sections but also with other standards (ISO, national requirements, EDQM guide, site qualification audits etc.). This is obviously both a challenge and consideration during the Standards review process, but also an opportunity to explore opportunities on how to improve and adapt the accreditation process to better meet the stakeholder needs. Initiatives like GoCART in Europe and 80:20 initiative (1) in the US are also working with JACIE and FACT respectively to find ways to leverage the accreditation to reduce the audit burden in the IEC context. 


There is a lot of work ahead for the steering committee and the sub-committees alike, but there is a sense of achievement not just when the whole of the project is completed but also during those important milestones when a particularly tricky standard has been agreed on or a sub-committee call has been completed with a section reviewed, and the explanation and the evidence for the Manual agreed. JACIE is hugely grateful to all members of the Steering and sub-committees for their time and commitment.