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 001/2021. These Directions consolidate and clarify the standards required under the Q&S Regulations.

Key themes from the questionnaire regarding activity during the peak of the pandemic
The standards that establishments licensed under an HTA human application licence should meet
What is a TPAIn the Human Application sector, a Third Party Agreement (TPA) may be used to provide an unlicensed third party with the authority to undertake licensable activities on behalf of an appropriately licensed establishment.DefinitionThe Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended) define a TPA as: “An agreement in writing between a licence...
The Regulatory Advice Service for Regenerative Medicine (the Advice Service) is a ‘One Stop Shop’ for research and development professionals across academia, industry and the NHS.
Information on the licensing requirements under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (Q&S Regulations).
New guidance on completing an HTA Preparation Process Dossier
Guide to the HTA system for the reporting SAEARs that are linked to the procurement, testing, processing, preservation, storage and distribution of human tissues and cells.
The list provides guidance to the human application sector on which types of tissues and cells are regulated under the Human Tissue (Quality and Safety for Human Application) Regulations 2007.

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