pharmaceutical Federation Efpia Reveals Results of Survey on EMEA Scientific Advice ProcedureIt has been nearly two years since the European Medicines Agency introduced its new scientific advice procedure. Christine Mayer-Nicolai, Marianne Poulmaire and Elisabeth Fournier-Qezari reveal the results of an Efpia survey of companies that used the system in its first year and discuss

摘要

In July 2006, the European Medicines Agency introduced a new procedure for providing sponsors with scientific advice during the development phase of their products1'3. The procedure, covered by Regulation (EC) No 726/20044, was designed to provide for, among other things, faster delivery of advice.In a bid to examine how satisfied scientific advice applicants were with the different stages of the new procedure, the European Federation of Pharmaceutical Industries and Associations (Efpia) conducted a survey of users of the system between 1 July 2006 and 30 June 2007. Efpia received 78 responses, which provided a sound data basis on which to identify trends related to how industry rated the new procedure.This article presents key results of the survey. In summary, it found that the industry's overall level of satisfaction with the new procedure was good. It also identified aspects of the procedure that could be improved, such as its duration, which could be shortened, especially in the presubmission phase.