The European Medicines Agency is looking forward to “a sustained level of activity” in 2007, largely due to the entry into force early in the year of the new European Union legislation on paediatric medicines, which will give the Agency a significant role in stimulating the availability of safe and effective medicines for use in children, the EMEA Board has said.
Late in December, the Board adopted the Agency’s budget for 2007, which totals 154.5 million euros compared to 2006’s budget of 138.6 million euros.
The Board also approved an increase in the maximum permitted number of Agency staff for the year, from 424 to 441, primarily to allow for the paediatric legislation and also for the provision of information for patients and healthcare professionals.
The second major development to impact the Agency’s work in 2007 is the accession to the EU of Romania and Bulgaria on January 1, which brings the number of countries participating in the EMEA to 30, totaling 27 EU Member States plus Iceland, Liechtenstein and Norway.
High level of MAA activity forecast
In 2006, the EMEA received 89 initial Marketing Authorisation Application for human medicines, 65 of which related to new medicines including orphan drugs. The Agency forecasts that this high level of activity will continue in 2007, and says it expects to receive some 85 initial MAAs during the year, of which, again, 65 will relate to new drugs.
It also projects that numbers of requests for scientific advice will increase 25% for the year, largely as a result of the new pediatric drug legislation.
In the EU, 50% or more of the medicines used in children have only ever been studied in adults, says the EMEA. Proposals for change began back in 1997, when a roundtable of experts organized by the European Commission at the EMEA highlighted the need to encourage pharmaceutical companies to investigate the safety and efficacy of their products in children, and to develop suitable formulations for use in young patients where these would be of benefit, even if the numbers of children using them are only small. The European Parliament agreed the Commission’s Regulation of Medicinal Products for Paediatric Use on June 1, 2006, and it is expected to become law shortly.
The European Commission has said that it expects this new regulation to result in children having to spend less time in hospital, plus fewer deaths and a better quality of life for sick children. By Lynne Taylor