Research Governance > The Medicines for Human Use (Clinical Trials) Regulations

The Medicines for Human Use (Clinical Trials) Regulations (2003) transpose EU Directive 2001/20/EC into UK law, providing a comprehensive regulatory framework for the conduct of clinical trials involving Investigational Medicinal Products and the provision of an opinion on the ethics of such clinical trials.

The Regulations are currently in draft form awaiting the outcome of a consultation exercise conducted by the Medicines and Healthcare products Regulatory Agency (MHRA). The full text of the Regulations together with MHRA Consultation letter MLX 287 can be accessed below.

A letter issued to the HPSS on 1 July 2003 is also available. It provides an update on developments relating to the Regulations as they impact on clinical trials and ethics committees. The letter also announces the formation of a DoH/ MRC project to address various concerns that were voiced during the MHRA consultation.