The Regulations which came into force in the UK on 1 May 2004 introduced new procedures for the authorisation of clinical trials. The regulations were required by the Clinical Trial directive 2001/20/EC and require that a CTA is made for all clinical trials involving investigational medicinal products. The Regulations only apply to trials of medicinal products. These are substances or combinations of substances which either prevent or treat disease in human beings or are administered to human beings with a view to making a medical diagnosis or to restore, correct or modify physiological functions in humans.
