Updated on 19 December 2012
The work program of EMA is accompanied by a budget of $306 million
Singapore: Charting out the plans for 2013, European Medicines Agency will 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, and 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. Some 10 applications for new veterinary medicines are expected, with three generic applications.
The work program is accompanied by a budget of $306 million (€231.6 million), an increase of 4.1 percent over 2012, which includes fee revenue of $238.2 million (€179.8 million) (3.8 percent increase compared with 2012, this increase is mainly due to inflation) and a European Union (EU) contribution of $51.9 million (€39.2 million).
The main focus of the agency is to ensure that assessment activities are conducted to the highest standards of quality, regulatory and scientific consistency. A number of initiatives are taking place to increase the support to the scientific committees and to further assure the quality and consistency of the Agency's scientific outputs. These include a review and optimisation of the scientific processes, including the coordination among the committees, and the continuing implementation of the conflicts of interest policies and their monitoring.
Implementation of new legislation
The agency has endorsed a number of activities for the continued implementation of the legislation that takes into account the Agency's budget constraints, as pharmacovigilance fees are not expected before 2015. Activities that will be implemented in 2013 comprise: collection of key information on medicines, including guidance preparation for patient reporting, better analysis and understanding of data and information, regulatory action to safeguard public health, including coordination of pharmacovigilance inspections, and communication with stakeholders.