Clinical trials of human medicines - existing regulatory regime
The regulatory regime for clinical trials in the UK is based on the EU Clinical Trials Directive  2 and is set out in the Medicines for Human Use (Clinical Trials) Regulations 2004 ("the CTRs"). The framework provides a scheme for regulating clinical trials of medicines involving humans that covers the authorisation of clinical trials, their ethical approval, the conduct of the trial including adherence to good clinical practice, the reporting of adverse events and breaches of the authorisation, the manufacture and importation of the medicinal products involved in the trial and their labelling. The regulatory system is again overseen by the UK licensing authority operating through the MHRA (as described in paragraphs 11 and 12).
	The EU legislation on which the CTRs are based is due to be repealed and replaced by a new EU Regulation  3.