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The new European Union Substances of Human Origin (SoHO) regulation and necessary conditions of its implementation in the tissue establishment cryobank.

Number: 0025

Author(s) : MERICKA P., JANDOVA M., GREGOR J., RUDOLFOVA S., LÁNSKÁ M., NAVRATIL P., SPACEK M., FULLER B.

Summary

The cryobank of the Tissue Establishment (TE) of the University Hospital Hradec Kralove is fully compliant with the requirements of current European Union (EU) legislation based on EU Directives implemented into the legislation of the Czech Republic by the Act No 296/2008, Coll. The TE is a holder of the national licence for procurement processing, storage at cryogenic temperatures and distribution of haematopoietic progenitor cells (HPC) and of solid tissues (ST). It is registered at European Commission (EC) under the codes CZ000426 for HPC and CZ000427 for ST. The HPC licence also covers procurement and cryopreservation of the starting material, suspension of autologous mononuclear cells, for manufacturing of registered CAR-T therapy product, Kymriah (Novartis, Switzerland). The new centralized EU regulation (1) was approved by the European Parliament and Council in June 2024 and should be implemented within 3 years. The necessary conditions for gaining SoHO preparation authorization by future SoHO Establishments will be the proof of compliance of their practice with the existing and future European Directorate for Quality of Medicines and Healthcare (EDQM) recommendations (2) and with the European Centre for Disease Prevention and Control (ECDC) recommendations. The timely action from the TE side is necessary in the following areas: Implementation of the revised panel of serology tests performed in cell and tissue donors according to the ECDC guideline, determination of the shelf life of cryopreserved cells and tissues on basis of cryostability studies, environmental control of the cryobank premises, full implementation of the ISBT 128 standard in cell and tissue product labelling, use of the new tools, such as MiRCA and GPTII elaborated by the EDQM experts for risk assessment, implementation of the Clinical outcome monitoring plan at clinical workplaces and participation of the TE staff in e-learning courses organized by EDQM.

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Details

  • Original title: The new European Union Substances of Human Origin (SoHO) regulation and necessary conditions of its implementation in the tissue establishment cryobank.
  • Record ID : 30033881
  • Languages: English
  • Subject: Regulation
  • Source: Cryogenics 2025. Proceedings of the 18th IIR International Conference on Cryogenics, Prague, Czech Republic, 7-11 April 2025.
  • Publication date: 2025/04/07
  • DOI: http://dx.doi.org/10.18462/iir.cryo.2025.0025

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