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Orphan Drugs In Australia

September 27, 2012

In Australia, the administrative authority involved in orphan drug regulations, is the Therapeutic Goods Administration (TGA). TGA is part of the Australian government’s Department of Health & Ageing.

Different global orphan drug policies and regulations (including Australia) are compared in the Comparison Chart presented in the Orphan Druganaut September 21, 2012 Blog Post.

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

–    Orphan drug policy was set up in 1997 in Australia

–    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

–    Waiver of application and evaluation and no annual registration fees

–    5-year exclusivity

–    All costs of the orphan drug designation process is covered by TGA

–    R&D not supported by grants or tax incentives.

The alphabetical list of designated orphan drugs in Australia.

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


From → Australia

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