The Medicines and Healthcare Products Regulatory Agency
The MHRA is an executive agency of the UK Government’s Department of Health and is charged with ensuring that medicines and medical devices work and are acceptably safe. It was established in April 2003 following a merger of the previous Medicines Control Agency and the Medical Devices Agency.
It regulates clinical trials and includes an inspectorate with oversight responsibilities.
The MHRA was charged with drawing up a Statutory Instrument which would have the effect of bringing Good Clinical Practice into UK law and the result was the United Kingdom Statutory Instrument 2004 No. 1031.
