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Pandemic Expected To Drive Rolling Review Upsurge At EMA

Agency Will Demand 50% of Full MAA Fee Upfront

 
• By Vibha Sharma

The European Medicines Agency is anticipating greater use of its rolling review process during the coronavirus pandemic. Companies who use it will be asked to pay upfront half of what they would pay for a full marketing application. 

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Regulators are speeding up their review efforts • Source: Shutterstock

The European Medicines Agency is expecting use of its rolling review procedure to increase during the current COVID-19 pandemic and has introduced a corresponding fee for companies using the mechanism.

The new rolling review fee of EUR 148,400 ($166,690) corresponds to half the basic fee for a full marketing authorization...

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