UK Regulation

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Category: Regulations

Published on Thursday, 11 September 2008 08:12

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Medicines and Healthcare products Regulatory Agency (MHRA)

Enhance and safeguard the health of the public by 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.

Scientific Advisory Committee on Genetically Modified Organisms (ACGMO)

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

Gene Therapy Advisory Committee (GTAC)

GTAC is the UK national research ethics committee (REC) for gene therapy clinical research according to the Medicines for Human Use (Clinical Trials) Regulations 2004 (http://www.opsi.gov.uk/si/si2004/20041031.htm, see article 14(5)). It is the only UK ethics committee empowered to approve clinical trials of gene therapy products according to the definition given in Part IV of Directive 2003/63/EC (amending Directive 2001/83/EC).

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