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.

Guidance for establishments on meeting HTA licensing requirements for the procurement of tumour samples to be used as a starting material in the manufacture of an Advanced Therapy Medicinal Product (ATMP).Certain types of immunotherapies require the use of tumour material in their manufacture. Where the tumour material will comprise part of the active substance of the final product, it will be...
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 and MHRA Policy on the Regulation of Blood as a Starting Material for ATMP Manufacture
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.
HTA policy on the regulation of faecal microbiota transplant
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.
EU Directives amending coding and import regulations will become law during 2016
Information about the regulatory framework applied to Advanced Therapy Medicinal Products (ATMPs)
How to provide a third party with the authority to undertake licensable activities on behalf of a licensed establishment
HTA advice to the human application sector for preventing the transmission of the Ebola virus via blood and blood components

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