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.
