FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

TGA Readies Orphan Drug Program Reform

April 25, 2017

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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