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The HTA was asked for details of serious adverse events and reactions (SAEARs) across multiple types of human application activities, broken down by year.
It is a mandatory requirement that the processes used to prepare tissue or cells for patient treatment (human application) do not render them clinically ineffective or harmful, and they must be validated.
The validation of the processes may be based on:
This guide explains the regulatory requirements for establishments in the Human Application sector.
The Human Fertilisation and Embryology Authority (HFEA) and the Human Tissue Authority (HTA) have been working together to reduce the regulatory overlap regarding the storage of ovarian and testicular tissue.
Issued 17 August 2009
The Designated Individual (DI) at the licensed establishment is responsible for ensuring suitable practices take place under the authority of the Human Tissue Authority (HTA) licence.
Licensed establishments are required to meet the criteria that are detailed in the HTA’s licensing standards.