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The framework document contains detailed information on the mandatory regulatory requirements that Organ Donation and Transplantation sector establishmen

Under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (Q&S Regulations), the HTA licenses and inspects establishments that...

This guide explains the regulatory requirements for establishments in the Human Application sector.

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...

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 Designated Individual (DI) at the licensed establishment is responsible for ensuring suitable practices take place under the authority of the Human Tis...

Issued 17 August 2009

The Human Fertilisation and Embryology Authority (HFEA) and the Human Tissue Authority (HTA) have been working together to reduce the regulatory overlap re...

This is the joint position from the Human Tissue Authority (HTA), Human Fertilisation and Embryology Authority (HFEA) and Medicines and Healthcare products...

Faecal microbiota transplantation (FMT) is recognised as an emerging treatment for recurrent Clostridium difficile infections in patients where antibiotic...

Guidance for establishments on meeting HTA licensing requirements for the procurement of tumour samples to be used as a starting material in the manufactur...

Importing tissue establishments must ensure that imports from third countries meet standards of quality and safety equivalent to those in the UK.

New EU regulations for medical devices (MDR) and in-vitro medical devices (IVDR) have been introduced.

As a regulator, transparency is not only an aspiration and value, but a statutory duty under the Human Tissue Act.