FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

TGA Readies Orphan Drug Program Reform

April 25, 2017
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Australia’s Therapeutic Goods Administration said it received positive feedback from industry groups on proposed changes to its orphan drug program.

The TGA undertook a consultation last year on the potential changes, which included increasing the population threshold for what constitutes a rare disease and requiring drug sponsors to demonstrate superior benefit over existing treatment options. The agency said it will release a formal transition plan for implementing the changes shortly.

While the 39 groups that offered comment were largely supportive, the vast majority disapproved of a provision under which an orphan designation would automatically lapse after a set amount of time if its sponsor did not submit it for approval. Responders, including Bayer, Novartis, Johnson & Johnson and Sanofi, also largely supported the proposal to continue waiving submission fees.

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