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EMA plans to levy pharmacovigilance fees from industry

Consultation on proposals comes as regulator prepares for major changes

The European Medicines Agency (EMA) wants the pharmaceutical industry to contribute to its drug safety monitoring costs.

Major changes to European pharmacovigilance legislation, the biggest for at least seven years, are set to come into effect next month when there will be new rules for monitoring, identifying and assessing adverse events.

The new legislation already enables the EMA to charge fees for its new pharmacovigilance activities, which were previously funded publically.

The consultation will just focus on the proposed structure and levels of these fees which are set to apply to all human medicines, irrespective of whether they were centrally or nationally authorised.

The EMA propose charging a basic, maximum fee of €80,300 for each assessment of a periodic safety update report (PSUR) for products that have been authorised for 2 years or more.

PSUR assessment fees for products that have been authorised for less than two years would be lower, with a proposed rate of €40,150.

The EMA says it wants to ensure all companies are treated equally, but acknowledges that small and medium sized firms, who already have some fee incentives, may have “justified reasons” to be charged less.

Currently, approximately 85 per cent of EMA's revenues derive from fees, and the remaining 15 per cent from the EU budget, but the regulator warns that fee regulation changes are need to allow adequate funding of the new pharmacovigilance legislation.

Last week the EMA's head of coordination and networking Henry Fitt told the the Reinforcing Public Safety conference in Croatia the regulator has no additional resources for implementing the changes and has yet to secure those for 2012.

The EMA's pharmacovigilance consultation will run until September 15, 2012

20th June 2012

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