Anavex Life Sciences Corp (AVXL)

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Australia has also implemented new expedited approval processes.

Posted 31 October 2016
By Zachary Brennan

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As part of an attempt to catch up with the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Health Canada, Australia’s Therapeutic Goods Administration (TGA) on Monday released five new consultations for public comment, including one that would forge new priority review and provisional approval pathways.

TGA’s priority review pathway, like Health Canada’s and FDA's pathway with the same name, will involve faster reviews of prescription drugs in certain circumstances, potentially allowing consumers with serious and life-threatening conditions to gain access to these medicines more quickly if an assessment results in a decision for registration.

Similarly, Australia’s provisional approval pathway, like FDA’s accelerated approval pathway and EMA’s conditional marketing authorization, will provide earlier access to certain promising new medicines that do not yet have a full dossier of clinical data but have solid early data on efficacy and safety (e.g. based on surrogate endpoints or other relevant data, rather than on patient safety and efficacy data from full Phase III clinical trials).
- See more at: http://www.raps.org/Regulatory-Focus/News/2016/10/31/26097/Australia%E2%80%99s-TGA-Looks-to-Mirror-US-FDA-EMA-With-Two-New-Expedited-Drug-Approval-Pathways/#sthash.8rdneayj.dpuf