Human Tissue Authority

The regulator for human tissue and organs

Regulating human embryonic stem cell lines for human application

The aim of regulating human embryonic stem cells is to ensure that the highest standards are met from their derivation in the laboratory through to their clinical application.

The HFEA is responsible for regulating the procurement of gametes and the associated processing involved in the creation of an embryo. The HFEA’s remit includes the use of embryos in the derivation of stem cell lines, but does not extend to the regulation of these stem cell lines themselves.

The HTA under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 regulates the processing, storage and distribution of stem cell lines for human application.

During the cell line derivation process the embryo is dissociated and it is at this processing stage that the HTA regulatory remit begins and the HFEA’s regulatory remit ceases.

When the derived hESC cell line is fully characterised and cultured to ensure uniform characteristics it is a condition of all HFEA research licences that the cell line is deposited in the UK Stem Cell Bank.

During the processing / derivation phase, stem cell lines do not come within medicines regulation. However, once Master Cell Banks [1] have been created with a reasonable expectation of clinical utility in a medicinal product, they fall within the remit of the MHRA. For further information regarding medicinal products and the regulatory remits of the HTA and the MHRA please see this link.

FAQs about the regulation of stem cell lines are here

HTA

The HTA was established on 1 April 2005 to regulate the removal, storage, use and disposal of human bodies, organs and tissue for a number of ‘Scheduled Purposes’ – such as research, transplantation, and education and training – set out in the Human Tissue Act 2004 (HT Act). The HT Act covers England, Wales and Northern Ireland. There is separate legislation in Scotland – the Human Tissue (Scotland) Act 2006 – and the HTA performs certain tasks on behalf of the Scottish Executive for example approval of living donation of organs.

On July 5 2007 the European Union Tissues and Cells Directives were transposed into UK law via the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (the Regulations). Under the Regulations the HTA regulates the procurement, testing, processing, storage, distribution and import/export of tissues and cells for human application. The Regulations cover England, Wales, Northern Ireland and Scotland.

The HTA is also responsible for approving transplantation of solid organs and bone marrow from living donors.

HFEA

The HFEA is the independent regulator for IVF treatment and embryo research. Our role is to protect patients and the public interest, to drive improvement in the treatment and research sectors and to provide information to the public and policymakers about treatment and researc

The HFEA was set up in August 1991 as part of the Human Fertilisation and Embryology Act 1990.  The HFEA's principal tasks are to license and monitor clinics that carry out in vitro fertilisation (IVF), donor insemination (DI) and human embryo research. The HFEA also regulates the storage of gametes (eggs and sperm) and embryos.

MHRA

The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem

Footnote

[1] A master stem cell bank can be defined as an aliquot of a single pool of cells which generally has been prepared from the selected cell clone under defined conditions, dispensed into multiple containers and stored under defined conditions. The MCB is used to derive all working cell banks.. Source: EudraLex Volume 4: EU guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Annex 2: Manufacture of Biological active substances and Medicinal Products for Human (revision 1).

Issue date: originally issued 3 May 2007 (reviewed August 2015).

 

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