The European Medicines Agency has published an upbeat annual report for 2007 and says that 2008 will see “even higher application numbers and a focus on advanced-therapy medicines”.
65 opinions on initial marketing authorisations for medicines for human use were adopted last year, 14 more than in 2006. Cancer medicines were the most-represented therapeutic category, followed by anti-infectives and alimentary-tract medicines.
90 applications for marketing authorisations were received – 12 more than in 2006 – including 11 applications for orphan medicines, 10 for generics and 10 for ‘biosimilars’. The EMEA added that despite the high volume of applications, all were evaluated within the regulatory timelines.
It also lauded the launch of the EMEA’s Paediatric Committee in July and said that “considerable efforts were made in 2007 to strengthen the proactive approach to safety of medicines”. Major progress on establishing “an intensive drug-monitoring system” was achieved through the delivery of the EudraVigilance Datawarehouse and Analysis System, which supports signal-detection and the assessment of adverse drug reaction reports.
EMEA executive director Thomas Lonngren said that the agency also made good progress to stimulating innovation within the EU and improving global cooperation on scientific and regulatory development. As for 2008, the agency forecasts a 12% increase in the number of initial applications for marketing authorisations for human medicines – up to 102 applications.
The EMEA concluded by saying that strong growth is also expected in the number of requests for scientific advice, with more than 360 requests expected.
