Brussels, 22/12/2005 (Agence Europe) - The management board of the European Agency for the Evaluation of Medicinal Products (EMEA) adopted the work programme for 2006 on 15 December. The programme will essentially depend on entry into force of the revised European pharmaceutical legislation which extends the centralised procedure for marketing authorisation (AMM) of medicines to all new active principles. The agency therefore expects there will be a rise in requests for approval, from 40 in 2005 to 47 next year. EMEA also foresees 8 requests concerning the evaluation of generic and biosimilar medicines. It should also be able to carry out the work made necessary by the new legislative proposals concerning “compassionate use” medicines, for example, as well as the evaluation of vaccine prototypes against pandemic flu which are to constitute the base for future authorisation dossiers to speed up the procedure once the virus has been identified. In the veterinary field, it expects 14 requests for approval and 12 requests for AMM extension.
In 2006, the Agency's budget will be EUR 123 551 000 (instead of 111 835 000 in 2005), with personnel numbers growing from 379 to 424.