The Provisional Approval Pathway pathway has been developed by the Therapeutics Goods Administration (TGA) of Australia.
This pathway can be used where The eligibility criteria are: • New prescription medicine or new indications medicine • For treating a serious condition • Favourable comparison against existing therapeutic goods • Major therapeutic advance • Evidence of a plan to submit comprehensive clinical data..
The Provisional approval pathway consists of five steps: provisional determination (3-6 months pre-dossier), pre-market registration (max. 255 working days), the provisional registration period (2 year initial period), extension of provisional registration (2 possible extensions – each up to 2 years), and transition to full registration (max. 255 working days).