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news.The European Medicines Agency has predicted that 2008 will see an increase in applications and enhanced focus on advanced-therapy medicines, according to PharmaTimes.
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According to European Medicines Agency (EMEA), 65 opinions on initial marketing authorizations for medicines for human use were adopted in 2007, 14 more than in 2006. The most-represented therapeutic categories were cancer medicines, anti-infectives and alimentary-tract medicines. The EMEA also said that 90 market authorization applications were received in 2007 compared to 78 in 2006. There were 11 applications for orphan medicines, 10 for generics and 10 for ‘biosimilars’.
The EMEA also commended the launch of the EMEA’s Paediatric Committee and said that the establishment of EudraVigilance Data warehouse and Analysis System, which supports signal-detection and the assessment of adverse drug reaction reports helped in creating an effective drug-monitoring system. The EMEA also predicted a 12% increase in the number of market authorization applications for human medicines in 2008.
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.