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
Love this post falconer66a and yes, I would be very curious to see what the spin might be in the “States” given that we may have Big Pharma advocates in the FDA who have no interest, or a divided interest, in accelerating A2-73’s rush to market.