Human Tissue Authority

The regulator for human tissue and organs

Material covered by the Quality and Safety for Human Application Regulations

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.

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
(for transplantation)

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

Audience: