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Preparation Process Dossiers guidance
It is a mandatory requirement that the processes used to prepare tissue or cells for patient treatment (human application) do not render them clinically in...
Material covered by the Human Tissue (Quality and Safety for Human Application) Regulations 2007
The list below provides guidance on which types of tissues and cells are regulated under the Human Tissue (Quality and Safety for Human Application) Regu
Establishments involved in cord blood collection
The Designated Individual (DI) at the licensed establishment is responsible for ensuring suitable practices take place under the authority of the Human Tis...
HFEA and HTA joint statement on ovarian and testicular tissue storage
The Human Fertilisation and Embryology Authority (HFEA) and the Human Tissue Authority (HTA) have been working together to reduce the regulatory overlap re...
Regulating human embryonic stem cell lines for human application
This is the joint position from the Human Tissue Authority (HTA), Human Fertilisation and Embryology Authority (HFEA) and Medicines and Healthcare products...
Regulation of faecal microbiota transplant
Faecal microbiota transplantation (FMT) is recognised as an emerging treatment for recurrent Clostridium difficile infections in patients where antibiotic...
Position on the procurement of tumour material
Guidance for establishments on meeting HTA licensing requirements for the procurement of tumour samples to be used as a starting material in the manufactur...
Compliance resource for US Imports
Importing tissue establishments must ensure that imports from third countries meet standards of quality and safety equivalent to those in the UK.
Clarification of the scope of the Medical Devices Regulation for tissues and cells products
New EU regulations for medical devices (MDR) and in-vitro medical devices (IVDR) have been introduced.
Transparency
As a regulator, transparency is not only an aspiration and value, but a statutory duty under the Human Tissue Act.
Acceptance of donor consent for anatomical examination
Medical school staff are sometimes faced with the challenge of deciding whether the consent given by potential donors, often many years before their death,...
Improving body donation information to support informed consent
Guidance on how establishments can improve their body donation information.