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IIR Cryogenics 2025 Conference: Implementing the new EU SoHO regulation for tissue cryobanks

P. Mericka et al. highlighted key points to be addressed by establishments during implementation of the new 2024 EU Regulation on standards of quality and safety for substances of human origin (SoHO) intended for human application. 

The new EU Regulation on standards of quality and safety for substances of human origin intended for human application (hereafter referred to as the SoHO regulation) was published in the Official Journal of the EU on 17 July 2024 [1]. It will apply as from 7 August 2027, 3 years after its publication and entry into force, with an extra year for certain provisions. 

 

In a communication presented at the last IIR Cryogenics conference, held in Prague, Czech Republic, on 7-11 April 2025, P. Mericka and colleagues from the cryobank of the Tissue Establishment (TE) at the University Hospital Hradec Králové reviewed the new EU regulation [2]. They highlighted key elements to be included by future SoHO establishments when developing implementation plans. 

 

According to the authors, the new EU regulation represents the most substantial change in cell and tissue banking since the implementation of three EU Directives in the first decade of the century. It covers a broader range of substances of human origin than the previous directives, which addressed only minimally manipulated cells and tissues. 

 

Regarding SoHO requiring cryopreservation, P. Mericka et al. listed the following key areas to be addressed in the implementation of the regulation:  

  • Introduction of a new spectrum of donor serology testing in line with future European Centre for Disease Prevention and Control (ECDC) recommendations 
  • Assessment of cell or tissue product shelf life based on cryostability studies 
  • Labelling of cell and tissue products according to the ISBT 128 standard  
  • Management of environmental parameters during processing and storage  
  • Ongoing risk assessment and management of cell and tissue procurement and processing using specific tools elaborated by the European Directorate for Quality of Medicines and Healthcare (EDQM) 
  • Safety assurance of cryobank premises, by means of permanent atmospheric oxygen level control and creation of the General liquid nitrogen safety plan 
  • Development of the Tissue Establishment (TE) contingency plan 
  • Development of a Clinical outcome monitoring plan 

 

The regulation also introduces new terminology. For instance, SoHO entities are defined as all workplaces involved in the procurement, processing, storage, quality control, and distribution of SoHO.

 

Timely implementation of the regulation by future SoHO establishments requires conducting a self-evaluation of current practices for compliance with EDQM and ECDC standards, introducing risk and novelty assessments using specific tools developed by the EDQM team, and defining the necessary corrective actions. 

 

 

Find out more in the paper available on FRIDOC 

The New European Union Substances of Human Origin (SoHO) Regulation and Necessary Conditions of its Implementation in the Tissue Establishment Cryobank   

 

Sources 

[1] https://health.ec.europa.eu/blood-tissues-cells-and-organs/soho-regulation/new-eu-rules-substances-human-origin_en  

[2] Mericka P., Jandova M., Gregor J., Rudolfova S., Lánská M., Navratil P., Spacek M., Fuller B. The New European Union Substances of Human Origin (SoHO) Regulation and Necessary Conditions of its Implementation in the Tissue Establishment Cryobank. Cryogenics 2025. Proceedings of the 18th IIR International Conference, Prague, Czech Republic, 7-11 April 2025. https://iifiir.org/en/fridoc/the-new-european-union-substances-of-human-origin-soho-regulation-150593