Guidance for establishments in the event of supply disruption
The following guidance has been issued to set out the HTA’s expectations regarding the use of alternative reagents and materials during the processing of t...
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Regulation on standards of quality and safety for substances of human origin intended for human application (SoHO)
This page contains information about the SoH
Material covered by the Human Tissue (Quality and Safety for Human Application) Regulations 2007
The list below provides guidance on which types of tissues and cells are regulated under the Human Tissue (Quality and Safety for Human Application) Regu
The Regulatory Advice Service for Regenerative Medicine (RASRM)
RASRM is a ‘one stop shop’ for research and development professionals across academia, industry, and the NHS.
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.
Establishments involved in cord blood collection
The Designated Individual (DI) at the licensed establishment is responsible for ensuring suitable practices take place under the authority of the Human Tis...
Position on the procurement of tumour material
Guidance for establishments on meeting HTA licensing requirements for the procurement of tumour samples to be used as a starting material in the manufactur...
HFEA and HTA joint statement on ovarian and testicular tissue storage
The Human Fertilisation and Embryology Authority (HFEA) and the Human Tissue Authority (HTA) have been working together to reduce the regulatory overlap re...
Clarification of the scope of the Medical Devices Regulation for tissues and cells products
New EU regulations for medical devices (MDR) and in-vitro medical devices (IVDR) have been introduced.
Regulating human embryonic stem cell lines for human application
This is the joint position from the Human Tissue Authority (HTA), Human Fertilisation and Embryology Authority (HFEA) and Medicines and Healthcare products...
Preparation Process Dossiers guidance
It is a mandatory requirement that the processes used to prepare tissue or cells for patient treatment (human application) do not render them clinically in...
Regulation of faecal microbiota transplant
Faecal microbiota transplantation (FMT) is recognised as an emerging treatment for recurrent Clostridium difficile infections in patients where antibiotic...