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Gene Therapy Legislation in the United Kingdom

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).

From the 1 June 2011 operational responsibility for the Gene Therapy Advisory Committee (GTAC) transferred to the National Research Ethics Service (NRES). The GTAC pages have been archived by the National Archives.

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)