Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at email@example.com if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Posted 20 December 2017 | By Michael Mezher
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.
Tags: Pharmacovigilance, Fees
Regulatory Focus newsletters
All the biggest regulatory news and happenings.