Human Tissue Authority

The regulator for human tissue and organs

Further guidance for mortuaries on how to formalise agreements with funeral directors
  • Funeral directors
Reporting obligations and processes regarding SARs and SAEs in HTA licensed establishments
  • Human application
  • Serious Adverse Event or Adverse Reaction (SAEARs)
Regulatory alert 001/2015 - West Nile Virus
  • Human application
  • Organ donation and transplantation
The standards that establishments licensed under an HTA research licence should meet
Practical guidance on correctly disposing of pregnancy remains
  • Fetal tissue
  • Pregnancy loss
New EU regulations for medical devices (MDR) and in-vitro medical devices (IVDR) have been introduced. These regulations entered into force on 25 May 2017 across EU Member States. However, most requirements will not fully apply until 26 May 2020 for the MDR, and 26 May 2022 for the IVDR.The scope of the MDR now includes certain products manufactured utilising derivatives of tissues or cells of...
  • Advanced Therapy Medicinal Products
  • EU tissue and cells directive
  • Human application
HTA policy on human tissue xenografts as relevant material, the consent implications and the licensing requirements under the HT Act 2004.
  • xenografts
HTA position statement on the regulation of dendritic cells and white blood cells other than granulocytes under the Human Tissue (Quality and Safety for Human Application) Regulations 2007
  • Dendritic cells
This document is designed to provide you with information about the Human Tissue Authority (HTA) inspection process, so that you and your staff can prepare for an HTA inspection.• There is a first part of this guidance, covering general inspection information• The appendix - applicable to both parts one and two - can be downloaded here• The whole document - parts one and two, plus the appendix -...
This guidance provides a comprehensive explanation of the responsibilities of toxicologists under the Human Tissue Act 2004.
  • Toxicology

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