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List Of Designated Orphan Drugs In Australia

December 11, 2012

       The alphabetical list of designated orphan drugs in Australia, from the Australian Government’s Department of Health & Ageing’s Therapeutic Goods Administration (TGA), has just been updated as of November 26, 2012.

        The following are a few features of Australia’s policies and regulations (per the OrphaNet portal) for rare diseases and orphan drugs : 

  1. Orphan drug policy was set up in 1997 in Australia 
  2. Orphan designation intended for drugs for rare diseases with prevalence of < 2,000 patients in the total Australian population of 18 million; 1,2/10,000 
  3. Waiver of application and evaluation and no annual registration fees 
  4. 5-year exclusivity 
  5. All costs of the orphan drug designation process is covered by TGA 
  6. R&D not supported by grants or tax incentives. 

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


From → Australia

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