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European Medicines Agency (EMA) Report (January – June 2012) With Statistics On Orphan Designations

October 15, 2012

       The European Medicines Agency (EMA) releases on September 27, 2012, the EMA Mid-Year Report (January – June 2012).  

        In this report, the following statistics are found on orphan drugs for January – June 2012 : 

1)  Significant increase in # of orphan designation applications – 30% above same period in 2011 (Page 2 & 16) 

2)  Terms for pilot collaboration on orphan medicinal products with Japanese MHLW/PMDA agreed & published (Page 12 – also, reference Orphan Druganaut August 13, 2012 Blog Post

3)   Performance indicators related to orphan designations (Page 16) : 

        –  100% of orphan designation applications evaluated within 90-day timeline

        –  89% of orphan summaries of opinion published within 1 month of the Commission decision on orphan designation

        –  100% of orphan public assessment reports (on review criteria) published within 1 month of the EC’s decision on marketing authorization

        –  31% (22 out of 70) of orphan products designated in parallel with FDA 

4)  # of new orphan medicinal products (Page 18) : 

        –  8 in 1st half of 2012. 

Copyright  © 2012-2013, Ann-Teresa Cusenza and Orphan Druganaut Blog.  All rights reserved.

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