Human Tissue Authority

The regulator for human tissue and organs

Human application

Under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (Q&S Regulations), the HTA licenses and inspects establishments that undertake the procurement, testing, processing, storage, distribution, import and export of tissues and cells for human application.

Licensed establishments include a wide range of organisations such as hospitals, stem cell laboratories and tissue banks, as well as private companies such as cord blood banks, suppliers of acellular material and establishments that procure the starting material for Advanced Therapy Medicinal Products (ATMPs). Establishments licensed under the Q&S Regulations work with a wide variety of tissue/cell types, including bone, skin, heart valves, bone marrow, stem cells, chondrocytes, and pancreatic islets.

Licensed establishments are required to meet the standards which are detailed in the HTA’s ‘Guide to Quality and Safety Assurance of Human Tissues and Cells for Patient Treatment’ as implemented by Directions 002/2018. These Directions consolidate and clarify the standards required under the Q&S Regulations.

The HTA's remit regarding the regulation of cell lines grown outside the human body for patient treatment
HTA position statement on the regulation of acellular material.
The transportation and delivery of tissues or cells intended for human application, including to or from other countries
Guidance for establishments licensed under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 who are involved in the procurement, receipt and acceptance of umbilical cord blood.
Defining ATMPs and explaining the HTA's role in regulating them
HTA position statement on the regulation of dendritic cells and white blood cells other than granulocytes under the Human Tissue (Quality and Safety for Human Application) Regulations 2007
HTA position on biological testing requirements for autologous donors of tissues and cells.
Information about the HFEA and HTA's work to reduce the regulatory overlap regarding the storage of ovarian and testicular tissue.

Pages

See also...