Human Tissue Authority

The regulator for human tissue and organs

Guidance for professionals

The filter and search function on this page allows you to refine down the full list of guidance that we provide for professionals to find specific items. Common searches for the HTA codes of practice and standards, licensing, fees and inspection information or for specific information for each of our regulated sectors can be found using the menu items above.

The objectives of Preparation Process Dossiers including process validation, reagents and materials, quality control and labelling
  • Human application
  • Preparation Process Dossiers
How to provide a third party with the authority to undertake licensable activities on behalf of a licensed establishment
  • Third party
Regulation regarding cells procured from a person and processed during a single surgical procedure
  • Single surgical procedures
Which research activities the HTA requlates and how consent should be obtained to use human tissue for research
  • Research
The HTA's remit regarding the regulation of cell lines grown outside the human body for patient treatment
  • Human application
  • Stem cells
Which records should be used by licensed and unlicensed establishments to evidence traceability and ensure a robust audit trail
  • Record retention
The Regulatory Advice Service for Regenerative Medicine (the Advice Service) is a ‘One Stop Shop’ for research and development professionals across academia, industry and the NHS.
  • Advanced Therapy Medicinal Products
  • Stem cells
Information regarding HTA Regulatory Alert 003/2008 on West Nile Virus
HTA position statement on the collection (procurement) of umbilical cord blood.
  • Cord Blood
  • Human application
  • Stem cells


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