Historical Archive

Ema, +10% Aic requests in 2011

An increase of 10% in the number of new applications for marketing authorizations for medicines for human use, going from 91 in 2010 to 100 in 2011. This is what the EMA board of directors recorded, which approved the annual report for 2011. Of the applications, 62 were submitted for new medicines, an increase of 35% compared to 2010. While the number of applications received for new marketing authorizations for veterinary products decreased slightly, the increase seen in veterinary scientific advice is an indicator that the interest in bringing innovative veterinary medicines via the centralized procedure to the market remains high. At the opening of the discussion on the budget for 2013, the executive director of EMA, Guido Rasi, represented the priorities and main objectives for the Agency for next year: the constant implementation of the legislation on pharmacovigilance and counterfeit medicines , the development of the Agency's communication activities with a view to greater transparency and clarity on the reasons for which decisions are taken. By 2013, the EMA expects 110 applications for marketing authorization for medicines for human use. The BoD adopted a preliminary draft budget for 2013 of €239.1 million (for 2012 of €222.5 million). The final budget will be proposed when the level of the EU contribution has been decided by the EU Parliament and Council.

Barbara Di Chiara – March 29, 2012 – PharmaKronos

Articoli correlati

Back to top button
Fedaiisf Federazione delle Associazioni Italiane degli Informatori Scientifici del Farmaco e del Parafarmaco