
European Medicines Agency Updates Seasonal Flu Vaccine Guidance
EMA releases an update on its flu vaccine guidance.
The European Medicines Agency released an update to its
The guidance states that vaccine manufacturers will be required to submit for each vaccine appropriate measures for proactive surveillance of the safety and effectiveness to regulatory authorities for review. The requirement is for the influenza season 2014-2015 onwards. With the new system in place, EMA will no longer require routine submission of clinical trials for annual strain-change updates. An interim guidance will be published by March 2014 and will address the principles of safety monitoring commitments that should form part of the proactive surveillance.
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