EMA Unveils New Data in Mid-year Report

October 9, 2014
Philip Ward

Philip Ward is ACT's European editor, phone +44 1244 538583, philipward1@btconnect.com

Applied Clinical Trials

During the first six months of 2014, the number of scientific advice and protocol assistance requests for human medicines received by the EMA increased by 16%

During the first six months of 2014, the number of scientific advice and protocol assistance requests for human medicines received by the European Medicines Agency (EMA) increased by 16% compared with the same period in 2013, according to the agency’s mid-year report presented to the Management Board on 2 October 2014.

Among the other highlights in the report are:

  • The number of orphan designation applications was 138, a 30% increase over results in the first six months 2013. There was an 8% increase in pediatric procedure applications.

  • EMA received 43 initial evaluation applications between January and June 2014, an increase of 19% compared with the same period of last year. This rise was mostly due to more generics applications received. The annual forecast for initial applications has been revised upwards from 88 to 118.

  • New orphan medicinal product applications saw an increase to 9 applications (from 5 in 2013) in the first six months of 2014, thus returning to the level of applications in 2011-2012. The number of new non-orphan medicinal product applications received by the end of June 2014 fell slightly, compared to the same period of 2013 (20 versus 24).

  • Biological medicinal product applications remained at the same low level as in 2013, as was also the case for hybrid and abridged applications.

 

 

For a full copy of the mid-year report, click here. (PDF)

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