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How Many Applications For Orphan Drugs Does European Medicines Agency Expect For 2013 ?

December 19, 2012

       The European Medicines Agency (EMA) expects for 2013 a stable total number of 100 applications for human medicines which includes :

  1. 54 for new medicinal products (excluding designated orphan medicines)
  2. 20 for new orphan medicines
  3. 20 for         generics.

         The EMA in 2012 had the following :

  1. 52 for new medicinal products (excluding designated orphan medicines)
  2. 13 for new orphan medicines
  3. 39 for         generics.

       In conclusion, the EMA expects for 2013 the following changes in the number of applications :

  1. Approximately a   4% increase in the # for new medicinal products
  2. Approximately a 54% increase in the # for new orphan medicines
  3. Approximately a 49% decrease in the # for generics.

References

EMA December 18, 2012 Press Release

Copyright © 2012-2013, Orphan Druganaut Blog. All rights reserved.

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