The European Medicines Agency (EMEA) performed well during the first half of 2008, undertaking particularly high levels of activity in the provision of scientific advice and protocol assistance, according to the Agency’s interim report.
The EMEA received 179 requests for scientific advice and protocol assistance during the first six months of this year, up 28% on the total for first-half 2007 and with 186 further applications expected to be received by year-end, according to the report. It notes that the provision of this advice in support of company R&D is a key activity area for the EMEA – one which fosters research and innovation in pharmaceuticals and, therefore, promotes the earlier availability of medicines for patients.
The number of applications for initial evaluation of medicines received during the period totalled six for orphan and 26 for non-orphan products, a similar level to that reported for first-half 2007, says the report, which also notes the contribution of the Agency to the successful operation of regulatory procedures for paediatric medicines within the European Union (EU) and implementation of new legislation on advanced-therapy medicines. In total, the Agency received 227 applications for review of paediatric investigation plans (PIPs) and waiver requests during the first half of the year, it says.
The report was presented earlier this month by EMEA executive director Thomas Lonngren ay the 60th meeting of the Agency’s Management Board. At the meeting, the Board also endorsed an updated EU telematics master plan, covering 2008-2013, which sets the vision and schedule for implementation of a set of pan-European information technology (IT) systems and databases used to support: post-authorisation monitoring of the risk-benefit balance of medicines in the EU; increased efficiency across the European medicines regulatory network; and increased transparency and availability of high-quality information on medicines for the public.
