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.

HTA and MHRA Policy on the Regulation of Blood as a Starting Material for ATMP Manufacture
Further information about the HTA licence fee
  • Fees
  • Licensing
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).Certain types of immunotherapies require the use of tumour material in their manufacture. Where the tumour material will comprise part of the active substance of the final product, it will be...
  • Advanced Therapy Medicinal Products
  • Regenerative medicine
Guidance on paragraph 100 of the HTA’s Code of Practice on the Human Transplantation (Wales) Act 2013 – persons who may not act as an appointed representative
  • Wales
  • Deceased donation
Guidance on paragraph 132 of the HTA’s Code of Practice on the Human Transplantation (Wales) Act 2013 - excluded relevant material
  • Deceased donation
  • Wales
Guidance on paragraphs 194-196 of the HTA’s Code of Practice on the Human Transplantation (Wales) Act 2013 - Persons who Lack Capacity to Consent
  • Deceased donation
  • Wales
Regulatory alert 001/2015 - West Nile Virus
  • Human application
  • Organ donation and transplantation
Importing tissue establishments must ensure that imports from third countries meet standards of quality and safety equivalent to those in the UK. The majority of imports originate in the US and we have identified a number of key differences in regulatory requirements. We have prepared this resource, with technical assistance from the FDA and AATB, to help UK-based importing tissues establishments...
  • Human application
  • Import and export
Issued 2 November 2016Notice for •    Designated Individuals (DIs) in the Human Application (HA) sector •    Licence contacts in the Organ Donation and Transplantation (ODT) sector Regarding an EU Rapid Alert on Substances of Human Origin issued by the Irish Health Products Regulatory Authority.ScopeThis alert is being issued by the Human Tissue...
  • Human application
  • Organ donation and transplantation
New guidance and FAQs to help improve body donation information to support informed consent.
  • Anatomy
  • Body donation

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