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Regulatory Focus™ > News Articles > EMA: Pharmacovigilance Fees to Rise in 2018

EMA: Pharmacovigilance Fees to Rise in 2018

Posted 20 December 2017 | By Michael Mezher 

EMA: Pharmacovigilance Fees to Rise in 2018

The European Medicines Agency (EMA) on Wednesday said it expects fees paid by drugmakers for pharmacovigilance applications to rise by 1.4% in mid-January 2018.

Pharmacovigilance fees in in the EU are set by Regulation (EU) No 658/2014, which includes provisions for the European Commission to adjust the fees to keep up with the rate of inflation as measured by the European Index of Consumer prices.

Due to a low level of inflation in 2015 (0.2%), the Commission in 2016 said that a fee increase was not justified for 2017.

But in a delegated regulation adopted in October, the Commission said it would increase pharmacovigilance fees beginning in 2018 to account for the combined inflation rate in 2015 and 2016.

"In view of the inflation rate for 2016, (1.2%) it is considered justified to proceed to such adjustment and to apply a cumulative adjustment taking into account both 2015 and 2016 inflation rates," the Commission said.

As such, EMA said it expects the fees to climb by 1.4% and plans to release full details on the adjusted fees in January once the regulation is published in the Official Journal of the European Union.



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