EMA Increases Fees Due to Significant Inflation

The European Medicines Agency (EMA) has increased its nonpharmacovigilance fees for new applicants and marketing authorization holder renewals by 0.3 percent and 5.3 percent respectively to account for the high inflation rates of 2020 and 2021.

The changes reflect a review that the agency conducts every year, after which it makes any fee adjustments effective Apr. 1. All applications received by March 31 will not have to pay the higher fees. Also, the agency decision anniversary date on granting marketing authorizations determines when the higher fees are due to the agency.

When it comes to fees linked to scientific advice or protocol assistance, the fee amount will be determined by the date of validation of the request for advice.

Any fee adjustments for pharmacovigilance studies will be determined later this year.