Professional

The list below provides guidance on which types of tissues and cells are regulated under the Human Tissue (Quality and Safety for Human Application) Regulations, 2007 (as amended) (the Regulations).

It is not intended to be an exhaustive list of the tissues and cells covered by the Regulations; rather, it provides information about various tissues and cells that stakeholders have contacted the HTA about.

The list below has not been affected by EU Exit.

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:

• An establishment’s own studies;
• Data from studies published by others with operation validation; or
• A retrospective analysis of clinical outcomes.

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

The requirements apply to establishments that store and import tissues and cells for human application, and to establishments that carry out the following activities either under their own licence or under the authority of a third-party agreement with an appropriately licensed establishment:

• procurement;
• testing;
• processing;
• distribution; or
• export of tissues and cells for human application.

The following guidance has been produced to bring clarity to the issues surrounding consent for research relating to transplantation where donors are deceased. The Human Tissue Act (2004), The Human Transplantation (Wales) Act 2013 and the Organ Donation (Deemed Consent) Act 2019 all require expressed consent for research activities; deemed consent which applies to transplantation activities in England and Wales does not apply to research activities.

In preparation for ODT establishments considering or planning, for transplantation services to resume, we have created this guidance. This is aimed at transplant centres considering using “clean sites” or alternative hospital premises to their base location in order to resume their transplant programmes.

You will need to inform the HTA of your plans using the contact details at the bottom of the page.