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Guide to the quality and safety of tissues and cells for human application

Essential guidance on the quality and safety of tissues and cells for human application

 

ESHRE Contributors to the former and current guide:

-   Edith Coonen, Netherlands
-   Giovanni Coticchio, Italy
-   Thomas Ebner, Austria
-   Kelly Tilleman, Belgium
-   Maria José de Los Santos, Spain
-   Carlos Plancha, Portugal
-   Kersti Lundin, Sweden
-   Ioana Rugescu, Romania
-   Johanna Tassot, Belgium
-   Cristina Magli, Italy
-   Anna Veiga, Spain
-   Søren Ziebe, Denmark

The 6th edition of the Guide to the quality and safety of tissues and cells for human application, published by the European Directorate for the Quality of Medicines & HealthCare (EDQM) in October 2026, is now available. The new edition has been extensively revised and restructured to reflect current best practice, emerging evidence, scientific advances, and evolving clinical applications.

The Guide provides up-to-date scientific, technical and ethical guidance for professionals, inspectors and health authorities involved in substances of human origin (SoHO) activities, from donor identification, evaluation and testing to collection, processing, storage, distribution and human application. It aims to support the quality and safety of tissues and cells and the protection of donors and recipients.

The 6th edition introduces a new structure distinguishing between standards, Good Practice Guidelines (GPG), recommendations and supplementary information. Terminology has also been updated to align with Regulation (EU) 2024/1938 on substances of human origin (SoHO). Part C now includes 52 SoHO monographs, 11 of which are new, providing information on defined SoHO preparations and their established clinical applications.

Medically Assisted Reproduction (Chapter 30) and Fertility Preservation (Chapter 31) are specifically relevant to reproductive medicine. ESHRE contributed to the development of the 6th edition.

The 6th edition is currently available in English and can be downloaded free of charge in electronic format from the EDQM FreePub website. There is no print version of the 6th edition. From December 2026, the Guide will be available exclusively through the EDQM SoHO Guides platform.