The EU regulation 2024/1938 on standards of quality and safety for substances of human origin intended for human application has been adopted on 13 June 2024.
Apart from a few specific provisions, it will apply from 7 August 2027. It will also repeal the currently applicable Directive 2002/98/EC on human blood and blood components and Directive 2004/23/EC on human tissues and cells, from 7 August 2027.
Please see below the slides of a talk entitled “EU regulation on SoHO: potential consequences on the generation of real-world data”, presented by A. MAHALATCHIMY at the 52nd EBMT Annual Meeting, 22-25 March 2026, Madrid, Spain, upon invitation by the GoCART Coalition for the Session on “The Power of Real-World Education and Real-World Data” chaired by Marion Subklewe (Munich, Germany) and Julio Delgado (Barcelona, Spain).
A complete summary of the EU Regulation on SoHO is available on the EUR-Lex website here in the 24 official languages in the European Union.
Please see below the poster entitled “The new EU regulation on SoHO: strengthening the protection of donors, recipients and offspring”, presented by A. MAHALATCHIMY, V. ROBY, C. CHABANNON, at the 52nd EBMT Annual Meeting, 22-25 March 2026, Madrid, Spain.
The 80 pages-full text is available on the EUR-Lex website here in the 24 official languages in the European Union.
Please find more information on the European Commission website:
Please find relevant information on Substances of human origin on the website of the European Centre for Disease Prevention and Control (An agency of the European Union)
Please find relevant information on Substances of human origin on the website of the European Directorate for the Quality of Medicines & HealthCare (A Directorate of the Council of Europe):
Published: 03/04/2026
Author:
Aurélie Mahalatchimy, EuroGCT WP4 Convenor, UMR 7318 DICE CERIC, Aix-Marseille University, CNRS, Aix-en-Provence, France