A guideline outlining how companies should prepare to conduct first-in-man studies of novel medicinal products in Europe, should be completed in July, 2007, according to Patrick Le Courtois, head of the Unit for Pre-Authorisation of Medicines for Human Use at the European Medicines Agency (EMEA).
Companies that want to know how quickly their applications for first-in-man trials will be evaluated in the UK will soon be able to go to the regulatory authority’s website for information on the review process, according to Elaine Godfrey of the Medicines and Healthcare products Regulatory Agency (MHRA).
Gordon Duff, a professor at the University of Sheffield School of Medicine and chairman of Britain's Commission on Human Medicines, said the Tegenero incident illustrates how little scientists understand about the safety of novel therapies. He said it is important that regulators in future share more information from preclinial studies of novel therapies.