This page contains information about the SoHO Regulation, which took effect in the EU in August 2024 and applies to Northern Ireland under the Windsor Framework. The regulations expand quality and safety standards for substances of human origin with full implementation by August 2027.
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.
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 Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended) licensing standards.
We’ve published new inspection reports from establishments in research, human application, anatomy, and post-mortem sectors.
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:
