Guidance for transplant centres considering using different premises
In preparation for ODT establishments considering or planning, for transplantation services to resume, we have created this guidance.
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Guidance on consent for transplantation research where donors are deceased
The following guidance has been produced to bring clarity to the issues surrounding consent for research relating to transplantation where donors are decea...
The Quality and Safety of Organs Intended for Transplantation: A Documentary Framework
The framework document contains detailed information on the mandatory regulatory requirements that Organ Donation and Transplantation sector establishmen
Human application
Under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (Q&S Regulations), the HTA licenses and inspects establishments that...
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.
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...
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
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...
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...
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...
Regulation of faecal microbiota transplant
Faecal microbiota transplantation (FMT) is recognised as an emerging treatment for recurrent Clostridium difficile infections in patients where antibiotic...
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...