The Management Board of the European Medicines Agency (EMEA) has adopted a draft budget for 2009 of 188.68 million euros, which is up 3.11% over 2008’s total.

Next year’s budget includes provisions to ensure that the Agency’s new responsibilities in relation to advanced-therapy medicines “will be supported by adequate resources,” including the inauguration of the new Committee for Advanced therapies (CAT) on January 15, says the Agency.

Other priority areas for the EMEA next year include: the provision of scientific advice in the area of innovative development methods; further strengthening of the Agency’s pharmacovigilance activities in relation to the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), risk management plans and signal detection; transparency and provision of information.

The Agency will publish its 2009 work programme on its website shortly. It expects most of its core activity areas to grow, and particularly scientific advice, work with medicines for paediatric use, information and transparency and cooperation with the Agency’s international partners. It also forecasts that the level of initial marketing authorisation applications for medicines for both human and veterinary use which are made to the Agency will remain stable next year; it is anticipating 112 applications for initial marketing authorisation for human-use medicines and 17 for veterinary use.

It has also decided that, from next March, all non-confidential Management Board documents, including agendas and minutes, will be made available to the public in a dedicated area on the EMEA website. This is the first of a number of transparency initiatives planned over the next two years, including plans to grant public access to EudraVigilance, the European Union (EU) database on adverse drug reactions, which will be presented for public consultation before the end of 2008.

Another initiative currently under way is related to access of the public to information about paediatric clinical trials held in EudraCT, the EU database on clinical trials. To bring all of these initiatives together, the Agency has launched a major review of its current transparency provisions, which is expected to result in the development of an EMEA transparency policy for discussion with stakeholders.

In addition to these initiatives, the Agency has started to look at the way it provides information about medicines. A project has now been started to re-design the EMEA website, the results of which are expected to be visible by the end of next year, it says.