Agency sets out work priorities for 2011
The European Medicines Agency will focus on preparing for the implementation of the new pharmacovigilance legislation during 2011, while continuing to carry out its core business efficiently and effectively, according to the work programme 2011 , published today.
The work programme states that the pharmacovigilance legislation, which comes into force in 2012, will have a major impact on the Agency's work, and that the Agency will be affected by the ongoing debate within European institutions on the upcoming falsified medicines legislation.
The document also explains that the Agency expects to see a further increase in the number of procedures it handles this year, but will remain focused on carrying out its core business of monitoring the benefits and risks of medicines. This work will continue amid the changes that the new legislative requirements will bring over the course of the year.
This year, the Agency will also focus on:
- communicating and engaging with its stakeholders, including patients;
- continuing to increase the Agency's level of transparency and openness;
- contributing to international activities and responding to the globalisation of pharmaceutical research, development and manufacturing;
- responding to public-health needs, including the availability of medicines for the elderly and improving animal health;
- fostering the European medicines regulatory network.
The Agency's 2011 budget of €209 million remains at around the 2010 level. Staff numbers also remain unchanged, with a ceiling of 567 temporary agents.
The work programme was adopted by the Agency's Management Board in December 2010. It represents the first steps in the implementation of the Agency's five-year vision outlined in the 'Road map to 2015'.