In April 2003, the UK Medicines Control Agency and Medical Devices Agency merged to form the Medicines and Healthcare products Regulatory Agency (MHRA). Most of the statistical work is confined to the Medicines Sector of this new Agency. Statisticians are involved in assessing clinical trial documentation submitted by pharmaceutical companies as applications for marketing authorizations. They are also involved in pharmacovigilance monitoring of currently marketed products.
Keywords:
clinical trials;
drug regulation;
pharmacovigilance