Draft guideline on influenza vaccines: non-clinical and clinical module

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Download document Draft guideline on influenza vaccines: non-clinical and clinical module
Reference number EMA/CHMP/VWP/457259/2014
Status draft: consultation open
First published 31/07/2014
Last updated 31/07/2014
Consultation start date 31/07/2014
Consultation end date 31/01/2015
Email address for submissions vwp@ema.europa.eu

Summary

As announced in the concept paper, the revision of the guidelines on influenza vaccines has been organised with the aim of developing one single influenza guideline that covers the regulatory, quality, non-clinical and clinical aspects. The present module covers the non-clinical and clinical requirements for new influenza vaccines.