Regulatory News

EMA Fees to Rise Beginning on 1 April

Beginning on 1 April 2017, the fees collected by the European Medicines Agency (EMA) from applicants and market authorization holders will increase by 1.2%, in line with the inflation rate in the EU for 2016.

According to EMA, the European Commission is working to adopt a regulation to adjust the fees. EMA says it will publish complete details on the fees in late March, after the regulation is adopted.

"Members felt that matters relating to the structure and level of [EMA] fees should be decided through the co-decision procedure rather than through implementing acts. Accordingly, they deleted the relevant parts of the text that empowered the Commission to adopt implementing acts relating to fees," according to text adopted by Parliament on 10 March 2016.

For drugmakers, EMA says the rate paid will depend on the type of fee and the timing of the application.

"All applications received by 31 March will be charged at the current fee and reduction rates. Applications received after that date will be charged the adjusted fees and be subject to the revised reduction rates," EMA says.

However, for scientific advice and protocol assistance, EMA says the fee charged will be determined by the date of validation of the request, rather than the date the request was submitted. Additionally, EMA says that annual fees will be determined by the anniversary date for the particular fee.

For the time being, pharmacovigilance fees will remain unchanged. EMA says it expects to update the fees for pharmacovigilance activities on 1 July 2017.

EMA