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Europe Reveals Generic Dominance


February 10, 2010.

The European Medicines Agency (EMA) statistics highlighting centralized-procedure activities for human medicines show a significant increase in positive opinions made between 2007 and 2009. However, the majority of approvals were for generic products.

According to the data, the number of positive approvals issued by the EMA increased the past three years, with 58 in 2007, 66 in 2008 and 117 in 2009. However, the statistics also show that the number of marketing-authorization applications for new products has decreased, with only 35 applications started in 2009 compared with 59 in 2007.

Generics have flourished, with 38 marketing-authorization applications started in 2009, compared with 30 in 2008 and six in 2007. The number of finalized marketing-authorization applications also significantly increased from five in 2007 and four in 2008 to more than 50 in 2009.

Meanwhile, marketing-authorization applications for orphan products remained stable with 11 applications started in 2007, 2008, and 2009. The number of negative opinions issued in each year also remained stable with seven in 2007, seven in 2008, and eight in 2009.

The data were published on the EMA's website alongside January 2010 figures. The agency said that it will be publishing statistics monthly to provide ongoing information about centralized-procedure activities for human medicines.

What do January 2010's statistics show? The agency has started eight marketing-authorization applications and also issued three positive opinions - two of which are for an orphan product and a generic product. As of yet, no negative opinions have been given, although three applications have been withdrawn prior to opinion.

According to the EMA, the monthly figures will be published on the its website within two weeks after the CHMP meeting. Commentaries and analysis will also be provided in the agency's annual reports.

Stephanie Sutton