Scientific Advice and Protocol Assistance by the EMEA

Abstract

To promote, as well as protect, the public health is a key charge of the EMEA (European Medicines Agency). One tool to achieve the former is to provide scientific advice. The scientific advice and protocol assistance procedures have recently undergone revision, with new procedures coming into effect from July 2006; these are intended to allow the EMEA to handle the increasing workload effectively.The Scientific Advice Working Party (SAWP) has expanded to 26 members, and the procedure timeframe has been made shorter (offering 40-or 70-day procedures). The SAWP also now takes external expert input at an earlier stage. Parallel (i.e. co-ordinated) scientific advice from both the EMEA and the US Food and Drug Administration is also now possible and the initial experience with this is presented involving Reparixin (INN; Dompé pha.r.ma SpA).