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Australia Lays Out Framework for Priority, Provisional Reviews

November 4, 2016

Australia’s Therapeutic Goods Administration is proposing expedited drug application reviews that would mirror programs in North America and Europe.

These priority and provisional reviews would have to meet three criteria: address an unmet need, treat a life-threatening condition and demonstrate either substantial or promising evidence of efficacy and safety – all of which are comparable to those set by the FDA, EMA and Health Canada.

Sponsors considering applying for the expedited reviews would be allowed to arrange pre-submission meetings six to seven months before filing an application.

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