Human Tissue Authority

The regulator for human tissue and organs

Part 2 - Revised licensing standards

The HTA’s revised Codes of Practice and licensing Standards for sectors regulated under the Human Tissue Act 2004 (HT Act) came into force on 3 April 2017.

The revised standards are grouped under four headings:

  • Consent (C);
  • Governance and Quality systems (GQ);
  • Traceability (T); and 
  • Premises, Facilities and Equipment (PFE).

The licensing standards for the PM sector consist of thirteen overarching statements, each of which is then broken down into a number of individual separate standards.

This new approach has led to an increase in discrete standards for this sector from 17 to 72, some with examples of what compliance looks like. The aim was to make the standards clearer, easier for establishments to demonstrate compliance, and also to enhance the HTA’s ability to make use of compliance information in judging risk.

The revised standards were also aligned with professional guidance. 

Some of the revised standards were set at a higher level than previously, in order to mitigate risks identified from our experience of regulating the sector through inspection and management of incidents.

The HTA’s criteria for classification of the severity of shortfalls remains unchanged. 

Last updated on: 23 May 2019