Human Tissue Authority
Published on Human Tissue Authority (https://www.hta.gov.uk)

Home > Guidance for the public

EU Tissue and Cells Directives [1]

Date published: October 2014

The European Union Tissue and Cells Directives

view [1]

Position on the procurement of tumour material [2]

Date published: October 2015

Guidance for establishments on meeting HTA licensing requirements for the procurement of tumour samples to be used as a starting material in the manufacture of an Advanced Therapy Medicinal Product (ATMP).

view [2]

Regulation of acellular material [3]

Date published: October 2014

Following the transposition of the European Union Tissues and Cells Directives into UK law via the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended), the HTA (as a risk based regulator) focused on directing its resources to ensuring that those activities that...

view [3]

Regulation of faecal microbiota transplant [4]

Date published: July 2015

Faecal microbiota transplants (FMT) are recognised as an emerging treatment for recurrent Clostridium difficile infections in patients where antibiotic and other lines of treatment have failed.

view [4]

Establishments involved in cord blood collection [5]

Date published: October 2014

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.

view [5]

Preparation Process Dossiers guidance [6]

Date published: October 2014

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:

view [6]

Coding and Import Directives [7]

Date published: July 2017

Two EU Directives have been implemented for the coding and import of tissues and cells for human application. These Directives are in force throughout the UK  and have been transposed through the The Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2018

view [7]

Changes to human application sector licences [8]

Date published: December 2017

The Regulations transposing EU import and coding Directives came into force on 1 April 2018. Changes to these Regulations affect all licensed establishments in the human application sector.

view [8]

Department of Health and Social Care's consultation [9]

Date published: December 2017

view [9]

HTA public evaluation 2017 - Focus group findings [10]

Date published: May 2018

The HTA conducts stakeholder evaluation every three years, and in 2016/17 it was agreed that it should focus on what the public know, think, and expect about and from the regulator of human tissue.

A series of focus groups were carried out to get in depth feedback on what the public knew...

view [10]

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Links
[1] https://www.hta.gov.uk/policies/eu-tissue-and-cells-directives
[2] https://www.hta.gov.uk/policies/position-procurement-tumour-material
[3] https://www.hta.gov.uk/policies/regulation-acellular-material
[4] https://www.hta.gov.uk/policies/regulation-faecal-microbiota-transplant
[5] https://www.hta.gov.uk/policies/establishments-involved-cord-blood-collection
[6] https://www.hta.gov.uk/policies/preparation-process-dossiers-guidance
[7] https://www.hta.gov.uk/coding-and-import-directives
[8] https://www.hta.gov.uk/changes-human-application-sector-licences
[9] https://www.hta.gov.uk/department-health-and-social-cares-consultation
[10] https://www.hta.gov.uk/hta-public-evaluation-2017-focus-group-findings
[11] https://www.hta.gov.uk/search?f%5B0%5D=field_sector%3A220
[12] https://www.hta.gov.uk/search?f%5B0%5D=field_sector%3A220&page=1
[13] https://www.hta.gov.uk/search?f%5B0%5D=field_sector%3A220&page=3
[14] https://www.hta.gov.uk/search?f%5B0%5D=field_sector%3A220&page=4
[15] https://www.hta.gov.uk/search?f%5B0%5D=field_sector%3A220&page=5
[16] https://www.hta.gov.uk/search?f%5B0%5D=field_sector%3A220&page=6
[17] https://www.hta.gov.uk/search?f%5B0%5D=field_sector%3A220&page=7
[18] https://www.hta.gov.uk/search?f%5B0%5D=field_sector%3A220&page=8
[19] https://www.hta.gov.uk/search?f%5B0%5D=field_sector%3A220&page=23