Snapshot

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..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Target time assessment is 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)..