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EMA releases an update on its flu vaccine guidance.
The European Medicines Agency released an update to its guidance for the annual strain change of influenza vaccines to reflect current knowledge. The change makes the guidance document consistent with the approach taken by other global regulatory authorities. An improved system that allows strengthened and sustainable monitoring of an influenza vaccine’s performance over the years in a real-life setting is introduced in the guidance.
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.
Source: European Medicines Agency