EMA to focus on pharmacovigilance and fake medicines in 2012
Will continue to review activities and processes to identify efficiency gains
The implementation of pharmacovigilance legislation and planning for new counterfeit medicine laws will be key focuses of the European Medicines Agency (EMA) in 2012.
The agency has just released its 2012 work programme, which was approved in December 2011.
The document forecasts a stable number of applications for marketing authorisations in 2012 and said the agency would ‘continue to review its activities and processes [to] identify…efficiency gains, re-allocation of resources and reprioritisation of activities’. This should put the agency in a position to manage its increased responsibilities with existing resources, said EMA.
Agency executive director Guido Rasi said the EU’s new pharmacovigilance legislation ‘significantly amends or adds to classic pharmacovigilance tasks…and directly impacts many parts of the regulatory process related to patient safety that were not historically considered as pharmacovigilance’.
He also stressed that EMA had to prepare for new EU counterfeit medicine controls, which come into force in January 2013.