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EMA to focus on pharmacovigilance and combating counterfeits in 2012

But European regulator's Work Programme 2012 says ‘internal reallocation and efficiency gains’ will be needed for the Agency to implement changes

The European Medicines Agency (EMA) will focus its plans for 2012 on implementing new pharmacovigilance legislation and preparing for new legislation on falsified medicines.

The aims are detailed in the Agency's Work Programme 2012, which also mentions austerity measures in the region as a key factor in the EMA's work over the course of the year.

These cost-cutting measures may even affect the EMA itself, with the Agency stating it will "continue to review its activities and processes so that it can identify areas where efficiency gains, re-allocation of resources and reprioritisation of activities may be possible".

Although the number of applications for marketing authorisation for human and veterinary medicines is predicted to be stable in 2012, the EMA is expecting increased responsibilities in a variety of areas, however, including the implementation of updated pharmacovigilance legislation.

Changes included the launch of the Pharmacovigilance Risk Assessment Committee (PRAC) and allowing the opportunity for any patient in any European Member State to report suspected adverse drug reactions to his or her national medicines authority.

However, the resources to implement these changes will have to be found through "internal reallocation and efficiency gains", rather than any additional funding or increased staff levels.

The EMA has also published transitional arrangements for its pharmacovigilance legislation which provide additional information on topics like the renewal of applications, the pharmacovigilance system master files and risk management plans.

Tackling the problem of counterfeit drugs is also high on the EMA's agenda, with new legislation on falsified medicines expected to come into force during January 2013.

The Agency will spend 2012 preparing the legislation, which aims to implement databases for falsified medicines as well as improve co-operation efforts with regulatory authorities in other regions.

Work will also be ongoing throughout 2012 to increase the EMA's transparency; improve the quality and consistency of its assessment processes; and strengthen its communication efforts with stakeholders.

All these efforts are part of the EMA's 'Road map to 2015', which was launched at the end of 2010 as a five-year plan for the Agency.

22nd February 2012

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