The list provides guidance to the human application sector on which types of ‘tissues and cells’ are regulated under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended).
It is not intended as exhaustive or exclusive, but is intended to provide information to stakeholders in respect of a number of materials for which advice on their status has previously been sought.
The HTA will review the list periodically and update it appropriately.
Where material is intended as a starting material/potential starting material for an Advance Therapy Medicinal Product (ATMP), further information on how the HTA regulates this type of activity can be found here. Frequently asked questions about ATMPs can be found here.
Where a material is not included within the following list, stakeholders are encouraged to contact the HTA for further advice.
|
Material |
Tissue and cells for the purposes of the Regulations? |
|---|---|
|
Acellular bone products*** |
Yes. See further information on the regulation of acellular material here |
|
Acellular skin products*** |
Yes. See further information on the regulation of acellular material here |
|
Adipose tissue |
Yes |
|
Amniotic membrane |
Yes |
|
Antibodies |
No |
|
Appendages (severed, for reattachment) |
No |
|
Blood (whole blood)* |
No – unless being collected as a starting material for ATMP manufacture. Click here for further information about the regulation of blood as a starting material for ATMP manufacture. |
|
Blood vessels |
Yes |
|
Bone marrow |
Yes |
|
Bone (e.g. femoral heads, skull flaps) |
Yes |
|
Breast milk for nutritional purposes |
No |
|
Cartilage cells |
Yes - may be collected as a starting material for an ATMP |
|
Cell lines |
Yes - when intended as a starting material/potential starting material for an ATMP |
|
Dendritic cells |
Yes, click here for further information about the regulation of dendritic cells and white blood cells. |
|
Dental pulp |
Yes - may be collected as potential starting material for an ATMP |
|
Donor lymphocytes (for the purposes of haematopoietic stem cell transplantation) |
Yes |
|
Eggs (ova)** |
No |
|
Embryonic stem cells |
Yes |
|
Embryos (outside the body)** |
No |
|
Faecal material*** |
No, click here for further information about the regulation of microbiota transplant. |
|
Fetal tissue |
Yes |
|
Fibroblasts |
Yes – when intended as a starting material/potential starting material for an ATMP |
|
Gametes** |
No |
|
Haematopoietic stem cells |
Yes |
|
Heart valves |
Yes |
|
Hepatocytes |
Yes |
|
Keratinocytes (type of skin cell) |
Yes – when intended as a starting material/potential starting material for an ATMP |
|
Ligaments |
Yes |
|
Limbal stem cells |
Yes |
|
Liver lobe**** |
No |
|
Meniscus |
Yes |
|
Musculoskeletal tissue |
Yes |
|
Non-blood derived stem cells |
Yes |
|
Ocular tissue (e.g. cornea, sclera) |
Yes |
|
Organs**** |
No |
|
Ovarian tissue |
Yes, see the HFEA and HTA joint statement on ovarian and testicular tissue storage for further information. |
|
Pancreatic islet cells |
Yes |
|
Placenta (for oral ingestion) |
No |
|
Plasma* |
No |
|
Platelets* |
No |
|
Primary cell cultures |
Yes |
|
Red blood cells* |
No |
|
Skin (allograft, autograft,) |
Yes |
|
Sperm cells (spermatozoa)** |
No |
|
Tendons |
Yes |
|
Teeth |
Yes |
|
Testicular tissue (for transplantation) |
Yes, see the HFEA and HTA joint statement on ovarian and testicular tissue storage for further information. |
|
Tumour tissue |
Yes |
|
Umbilical cord blood |
Yes, click here for further information for establishments involved in cord blood collection |
|
Umbilical cord tissue |
Yes - may be collected as a potential starting material for an ATMP |
Notes
* While outside the definition of tissue and cells for the purposes of the Regulations, these materials fall under the Blood Safety and Quality Regulations 2005 and are regulated by the MHRA.
** While outside the definition of tissue and cells for the purposes of the Regulations, these materials fall under the Human Fertilisation and Embryology Act 1990, and are regulated by the HFEA.
*** These materials are currently subject to a policy decision by HTA to take a proportionate approach to enforcement. Please contact the HTA for further advice.
**** While outside the definition of tissue and cells for the purposes of the Regulations, these materials fall under the Quality and Safety of Organs Intended for Transplantation Regulations 2012. Please refer to the organ donation and transplantation section of our website for further information.
Updated December 2015