Anavex Life Sciences Corp (AVXL)

[XenaLives]

2.4.5 Priority review designated applications
TGA now has a formal Priority review pathway for faster assessment of vital and life-saving prescription medicines for which a complete data dossier is available. The target timeframe of 150 working days is up to three months shorter than the standard prescription medicines registration process. A valid Priority review designation must be held in order to access the Priority review pathway. More information on Priority review is available at:

Priority review designation: A step-by-step guide for prescription medicines
Priority review designation eligibility criteria: Including supporting documentation
Priority review registration process

2.4.6. Provisional approval pathway
The TGA now has a formal Provisional approval pathway for the provisional registration of prescription medicines on the basis of preliminary clinical data, where there is the potential for a substantial benefit to Australian patients. A valid Provisional determination must be held in order to access this pathway.

More information on Provisional approval is available at:

Provisional approval determination: A step-by-step guide for prescription medicines
Provisional approval determination eligibility criteria: Including supporting documentation
Provisional registration process: a step-by step guide for prescription medicines
Provisional registration extension and transition to full registration

https://www.tga.gov.au/prescription-medicines-registration-process