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.
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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.
Updated on
23 Dec, 2025
Regulation on standards of quality and safety for substances of human origin intended for human application (SoHO)
Find out about the EU SoHO Regulation and full implementation in Northern Ireland from August 2027.
Updated on
26 Feb, 2026
Annual activity data collection
Information about annual data collection in the Human Application Sector.
Updated on
23 Dec, 2025
HTA Guide to Quality and Safety Assurance for Tissues and Cells for Patient Treatment
This guide explains the regulatory requirements for establishments in the Human Application sector.
Updated on
09 May, 2025
Human application sector - HTA standards
Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended) licensing standards.
Updated on
11 Mar, 2026
Human application serious adverse event and reaction (SAEARs) reporting
How to report adverse events and reactions for human application.
Updated on
11 Mar, 2026
Material covered by the Human Tissue (Quality and Safety for Human Application) Regulations 2007
Overview of which tissues and cells fall under the Human Application Regulations and when alternative regulators apply.
Updated on
23 Dec, 2025
Position statement on the biological tests required for autologous donors of tissues and cells
Guidance on required serum testing for autologous tissue and cell storage, including mandatory infection screening and consent rules.
Updated on
17 May, 2026
Regenerative medicine and the regulation of advanced therapies medicinal products
HTA licensing for procurement, storage, and processing of tissues for ATMP manufacture.
Updated on
23 Dec, 2025
The Regulatory Advice Service for Regenerative Medicine (RASRM)
Central advice service offering streamlined regulatory guidance for regenerative medicine and ATMP developers across multiple UK regulators.
Updated on
23 Dec, 2025
Establishments involved in cord blood collection
This page sets out HTA requirements for cord blood procurement, including training standards, third‑party agreements, and reporting of serious adverse events.
Updated on
23 Dec, 2025
Position on the procurement of tumour material
Explains licensing, quality, and safety requirements for procuring, storing, processing, and importing tumour material.
Updated on
23 Dec, 2025
HFEA and HTA joint statement on ovarian and testicular tissue storage
Explains regulation of the storage of ovarian and testicular tissue, outlining licensing needs for fertility treatment, transplantation.
Updated on
23 Dec, 2025
Clarification of the scope of the Medical Devices Regulation for tissues and cells products
Explains which human tissue and cell products fall under the Medical Devices Regulation and which are regulated under the Human Tissue and Cells framework.
Updated on
23 Dec, 2025
Regulating human embryonic stem cell lines for human application
Joint guidance from HFEA, HTA, and MHRA outlining how human embryonic stem cell lines are regulated.
Updated on
23 Dec, 2025
Regulation of faecal microbiota transplant
Information on regulation of Faecal microbiota transplantation (FMT).
Updated on
23 Jun, 2026
Compliance resource for US Imports
UK‑licensed importing tissue establishments must ensure third‑country imports meet quality and safety standards equivalent to UK requirements.
Updated on
23 Jun, 2026
Third party agreements (TPA)
Information and guidance on third party agreements.
Updated on
06 Dec, 2022
Independent audits guidance
The HTA’s HA licensing standard, GQ2c, requires an audit to be conducted in an independent manner at least every two years.
Updated on
23 Dec, 2025
Preparation Process Dossiers guidance
Explains the requirement to validate tissue and cell preparation processes for human application, and outlines how the HTA reviews validation using the Prepar...
Updated on
02 Jun, 2026
Tissue Types
View all tissue categories and their associated types.
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