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 003/2010. These Directions consolidate and clarify the standards required under the Q&S Regulations.

New EU regulations for medical devices (MDR) and in-vitro medical devices (IVDR) have been introduced. These regulations entered into force on 25 May 2017 across EU Member States. However, most requirements will not fully apply until 26 May 2020 for the MDR, and 26 May 2022 for the IVDR.The scope of the MDR now includes certain products manufactured utilising derivatives of tissues or cells of...
This page provides background information on the implementation of the EU Tissue and Cells Directive via the Human Tissue (Quality and Safety for Human Application) Regulations 2007.
HTA advice to the human application sector for preventing the transmission of the Ebola virus via blood and blood components
Issued 10 May 2017Notice for •    Designated Individuals (DIs) in the Human Application (HA) sector ScopeThis alert is being issued by the Human Tissue Authority (HTA) and includes information relevant to DIs of establishments which use human albumin during the processing of tissues or cells for human application. Please circulate this information to staff within your...
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.
Defining ATMPs and explaining the HTA's role in regulating them
Issued 2 November 2016Notice for •    Designated Individuals (DIs) in the Human Application (HA) sector •    Licence contacts in the Organ Donation and Transplantation (ODT) sector Regarding an EU Rapid Alert on Substances of Human Origin issued by the Irish Health Products Regulatory Authority.ScopeThis alert is being issued by the Human Tissue...
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.
The HTA is the UK Competent Authority for the purposes of the EU Tissues and Cells Directives, which set standards of quality and safety in relation to human tissues and cells intended for human application. Establishments wishing to import human tissues and cells for human application from a country outside of the EU into the UK must be licensed by the HTA for the activity of import.Please...
Information about the regulatory framework applied to Advanced Therapy Medicinal Products (ATMPs)

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