Applying for a prescription medicine via the priority review pathway
The priority review pathway is a formal mechanism for faster assessment of vital and life-saving prescription medicines.
The priority review pathway has the same legislative timeframe as our standard pathway for new medicine applications (255 working days). The target timeframe is 150 working days.
Medicines for treating serious or life-threatening conditions are eligible for priority review. Eligibility criteria apply.
We assess the evidence about a medicine and decide quickly so it can be available to patients as soon as possible.
We evaluate priority medicines based on the same level of evidence as the standard pathway.
What to consider before applying
Applying for registration via the priority review pathway is a two-part process - determination and registration.
Priority determination is a prerequisite for priority registration.
Priority determination remains in force for 6 months and cannot be extended.
You will need to submit your application for priority registration during this 6-month period.
Determination approval does not guarantee registration.
How to apply
To apply along the provisional approval pathway, you will need:
- TGA client ID number
- access to the TGA Business Services portal. See: TGA Business Services: getting started with TGA.
For guidance on completing a determination application form, see Completing a determination or designation application form in TGA Business Services.
Check granted priority determinations
To see what medicines have already been granted priority determination, see Prescription medicines determinations and designations.