Regulation on standards of quality and safety for substances of human origin intended for human application (SoHO)
The Regulation on Standards of Quality and Safety for Substances of Human Origin (SoHO) Intended for Human Application (also referred to as the SoHO Regulation) came into force in the European Union (EU) in August 2024.
Reporting an incident to HTA
HTA licensed establishments in the Post-mortem, Human Application and Organ Donation and Transplantation sector are required to report incidents to the HTA.
How to report them are different for each sector.
Stakeholder engagement
Throughout the year we host a programme of stakeholder engagement events.
Our sector-focused stakeholder forums have given us the opportunity to share updates and hear feedback on our regulation with leaders from each sector we regulate.
We've also started a programme of roundtables to discuss specific topics relevant to the sectors.
Membership of our stakeholder groups consists of leaders from each sector, and we're also looking at opportunities to hear from a wider group of professionals in the near future.
Human application sector - HTA standards
Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended) licensing standards.
Latest inspection reports February 2023
We’ve published new inspection reports from establishments in research, human application, anatomy, and post-mortem sectors.
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Inspection reports from the last 7 days
We’ve published 6 new inspection reports from establishments in human application, research, and post-mortem sectors.
On inspections we look at compliance with HTA standards including consent, governance and quality systems, traceability, and premises, facilities and equipment. We check whether there are any minor, major or critical shortfalls against these standards.
Read the latest reports: