On 6 October 2026, the European Directorate for the Quality of Medicines & HealthCare (EDQM) published the 6th edition of the Guide to the quality and safety of tissues and cells for human application, providing updated technical and ethical guidance for professionals working across the substances of human origin (SoHO) field.
The extensively revised edition reflects current best practice, emerging evidence, scientific advances and evolving clinical applications. It introduces a clearer structure distinguishing standards, Good Practice Guidelines, recommendations and supplementary information, and updates terminology to align with the new EU SoHO Regulation (EU) 2024/1938.
The publication is particularly timely as the European SoHO community prepares for the new regulatory framework. By translating evolving regulatory, scientific and professional expectations into practical guidance, the Guide provides an important reference for professionals, establishments, inspectors and competent authorities working to safeguard the quality and safety of SoHO throughout the pathway from donor identification and evaluation to clinical application and patient follow-up.
EBMT is proud to have contributed to the development of the new edition alongside other European and international professional organisations. We extend our sincere thanks to Nina Worel for her important contribution as EBMT’s representative to the EDQM, helping to ensure that the expertise and perspectives of the transplantation and cellular therapy community were represented in this important work.
The 6th edition is available electronically and free of charge from the EDQM website.