EMA Fees Lower Slightly Due to Inflation Rate

Drugmakers in the European Union will pay slightly lower fees starting today, under an annual adjustment that reflects the inflation rate for the previous year.

The decrease of 0.1 percent applies to European Medicines Agency fees for marketing authorization applications, postauthorization procedures, pharmacovigilance, scientific advice and inspections.

For scientific advice and protocol assistance, the new fees apply if the request was agreed to after on or after April 1. Requests acknowledged prior to that day are subject to the old fees. For annual fees, any applications due after April 1 will be charged under the adjusted level.

An explanatory note on the fees is available at www.fdanews.com/03-30-15-EMA-Fees.pdf. — Jonathon Shacat