EU to issue guidance on clinical trials in the autumn
This article was originally published in Clinica
Executive Summary
The Clinical Evaluations Task Force intends to issue in the autumn formal guidance for manufacturers on clinical trials. The guidance, known as a meddev (guidance endorsed by the European Commission), will clarify precisely what the manufacturers' obligations are in terms of using already existing clinical data and explain when manufacturers need to conduct full clinical trials. It will also explain the precise role of notified bodies, Steve Owen, head of European & Regulatory Affairs at the Medicines and Healthcare products Safety Agency told the 11th Annual ABHI Conference in London on June 17. The meeting was organised by IBC UK Conferences.