The European Medicines Agency noted the “outstanding performance” of the network which allowed the agency itself to contribute to the European response to the pandemic with scientific opinions, leading to three pandemic vaccines being approved and antiviral drugs being recommended.
And despite resources being moved to deal with H1N1 the agency conducted its other activities with quality, regularly meeting deadlines.
Last year many core activity areas were busier: requests for scientific advice were up 20%, orphan designations were up 38%, variations in type II increased by 20%.
A total of 96 applications to authorise medicines for marketing were submitted, 7% fewer than in 2008, half of which related to generic and hybrid medicines and informed consent applications – but still 60% more than the initial forecast.
Copyright Press Association 2010
European Medicines Agency