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PharmTech Europe


Pharmaceutical Technology Europe
Volume 22, Issue 3

Figures published by the European Medicines Agency (EMA) relating to centralised procedure activities for human medicines show a significant increase in the number of positive opinions made between 2007 and 2009; however, the majority of approvals are for generic products.

According to the data, the number of positive approvals issued by the EMA has increased year on year — 58 in 2007, 66 in 2008 and 117 in 2009. However, the statistics also show that the number of marketing authorisation applications for new products has decreased, with only 35 applications started in 2009 compared with 41 in 2008 and 59 in 2007.

Generics, on the other hand, have flourished. 2009 saw the initiation of 38 marketing authorisations for generic products, compared with 30 in 2008 and only 6 in 2007. The number of finalised marketing authorisation applications for generics has also increased significantly, from 5 in 2007 and 4 in 2008, to more than 50 in 2009. Interestingly, however, it is a different story for similar biological products (so called 'biosimilars'), which have seen a decrease in the number of both started and finalised applications (started applications: 10, 3 and 1 for 2007, 2008 and 2009, respectively; finalised applications: 5, 6 and 0 for 2007, 2008 and 2009, respectively).

Meanwhile, marketing authorisation applications for orphan products have remained very stable with 11 applications started in 2007, 2008 and 2009. The number of negative opinions issued in each has also remained very stable with 7 in 2007, 7 in 2008 and 8 in 2009.

The data were published on the EMA's website alongside figures relating to January 2010. The agency has said it will be publishing statistics every month to provide ongoing factual information about centralised procedure activities for human medicines. Commentaries and analysis of the figures will be provided in the agency's annual reports.

So what do January 2010's statistics show? The agency has already started 8 marketing authorisation applications and also issued three positive opinions— 2 of which are for an orphan product and a generic product. As of yet, no negative opinions have been given, although 3 applications have been withdrawn prior to opinion.

According to the EMA, the figures complement the Committee for Medicinal Products for Human Use (CHMP) monthly report and will be published on the EMA's website within two weeks following the end of the CHMP meeting.

Source of figures: European Medicines Agency 2010

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