The European Union Tissue and Cells Directives
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).
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...
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.
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.
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:
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
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.
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...
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=24