The European Medicines Agency (EMA) has released the third module of a new overarching guideline on influenza vaccines for a three-month public consultation. With this publication, the EMA is now close to finalizing the establishment of a revised regulatory framework that aims to facilitate the prompt assessment of new influenza vaccines.
The procedural guidance describes all regulatory pathways for the authorization or the modification of influenza vaccines intended to be used either in seasonal, pre-pandemic, or pandemic settings. It follows the publication of a module on the quality requirements for these vaccines in April 2014 and the release of a draft module on the non-clinical and clinical requirements for public consultation in July 2014.
The new overarching guideline is intended to cover and update in one single, consolidated document all aspects of the development of influenza vaccines in all epidemiological situations (i.e. seasonal, pandemic and pre-pandemic).
The EMA says that the guidance has been developed based on the experience gained from many years of seasonal vaccination campaigns, the 2009/2010 influenza A(H1N1) pandemic, requests for scientific advice received from vaccine developers, and applications for marketing authorization. The guidance applies to vaccines for which ample regulatory experience has been gained, as well as to some novel types of vaccines.
Comments on the draft regulatory and procedural module of the influenza vaccines guideline are invited until January 30, 2015.