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New Drug Safety Monitoring Fees Come Into Effect in Europe

Posted 27 June 2014 | By Alexander Gaffney, RAC

New Drug Safety Monitoring Fees Come Into Effect in Europe

User fees paid by pharmaceutical companies, intended to fund regulatory activities by offsetting their expense, are set to rise in Europe under a new regulation published this week.

The fees are intended to pay for new pharmacovigilance activities—basically the monitoring of medicines after their initial approval—that were required under legislation passed in 2010 and amended in 2012. The law, known as the pharmacovigilance legislation, is intended to centralize the collection and evaluation of drug adverse event information.

As EMA explained in 2012, when it first began collecting the user fees, the legislation greatly expands the regulators' role in overseeing drug safety in postmarket settings, thereby justifying the collection of additional resources. EMA's new centralized role would be a "service to the industry," it maintained.

However, as explained by EMA, those fees are now set to rise and expand, allowing regulators to collect fees for even more activities, and more money for those activities that it already undertakes.

Under the new scheme, sponsors will be charged the following:

  • Post-authorization safety studies (€43,000)
  • Evaluations conducted under safety referrals (€179,000 standard)
  • Periodic safety update reports (€19,500 each)
  • Literature monitoring (€67)

EMA will also begin collecting annual fees next year for nationally authorized medicines. Centrally authorized medicines are already subject to an annual fee.

Sponsors of generic pharmaceuticals will also be subject to the user fee provisions for the first time, albeit at a reduced rate, the regulation explains. "However, in cases where those medicinal products are part of any of the pharmacovigilance procedures carried out at Union level, the full fee should be charged in view of the work involved," it adds.

The new fees are set to go into effect on 26 August 2014, EMA said.


EMA Statement

EU Regulation

Categories: Regulatory News

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