Part of the United Kingdom Department of Health, the Medicines and Healthcare products Regulatory Agency (MHRA)  is the government executive agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe. The competent authority for clinical trials with GMOs is either the Health and Safety Executive (HSE) or the Department of the Environment, Food and Rural Affairs (DEFRA). Both HSE and DEFRA are part of the Joint Regulatory Authority (JRA), ensuring close collaboration.

The Scientific Advisory Committee on Genetically Modified Organisms (SACGM) provides technical and scientific advice to the UK Competent Authorities on all aspects of the human and environmental risks of the contained use of genetically modified organisms (GMOs).

The Gene Therapy Advisory Committee (GTAC) has UK-wide responsibility for the ethical oversight of proposals to conduct clinical trials involving gene or cell therapies derived from stem cell lines. This means that applications for gene or stem cell therapies must be reviewed by GTAC only. The Committee has also advised Ministers on the development and use of gene and stem cell therapies and works with other agencies with an interest in this area.

See also: Standards for gene therapy clinical trials based on pro-active risk assessment in a London NHS Teaching Hospital Trust. The relevant regulations covering gene therapy using genetically modified vectors are reviewed and illustrated with the approach taken by a large teaching hospital NHS Trust. The article describes the processes developed in Hammersmith Hospitals Trust since 2001 to undertake gene therapy trials.

(Last reviewed by the Competent Authority: 23 June 2011)