EMA 2013 work program and budget endorsed by management board

The European Medicines Agency’s Management Board revealed yesterday that, at its meeting on December 13, it adopted the EMA’s work program and budget for 2013. The Agency’s priorities will be to continue to ensure that assessment activities are conducted to the highest scientific levels, to increase efficiency in its activities, and to develop initiatives for greater transparency and communication with stakeholders.

Further specific drivers include the continued implementation of the pharmacovigilance legislation and the new falsified medicines legislation, as well as the planned revision of the veterinary medicines legislation.

In 2013, the Agency expects a stable total number of applications for human medicines, with 100 applications in 2013. These include some 54 applications for new medicinal products (excluding designated orphan medicines), 20 new orphan medicines and 20 generic applications (2012: 52, 13 and 39 respectively). Some 10 applications for new veterinary medicines are expected, with 3 generic applications (2012: 9 and 3 respectively).