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.
Issued: 14 August 2018Notice for: •    Designated Individuals in the Human Application sector •    Licence contacts in the Organ Donation and Transplantation sector  ScopeThis alert is being issued by the Human Tissue Authority (HTA) and includes information about recent cases of West Nile Virus (WNV) in individuals in Romania and France.Please...
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.
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...


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