Snapshot

The Priority Registration Process pathway has been developed by the Therapeutic Goods Administration (TGA) of Australia.

This pathway can be used where Reserved for new prescription medicines or new indications for the treatment, prevention, or diagnosis of a life-threatening or seriously debilitating condition; and either: there are no therapeutic goods that are intended to treat, prevent or diagnose the condition included in the Australian Register of Therapeutic Drugs (ARTG) (except in the part of the ARTG for goods known as provisionally registered goods) or if one or more therapeutic goods that are intended to treat, prevent, or diagnose the condition are included in the ARTG (except in the part of the ARTG for goods known as provisionally registered goods), there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention, or diagnosis of the condition compared to those goods; and there is substantial evidence demonstrating that the medicine provides a major therapeutic advance. An applicant requires a complete dossier to be eligible for priority determination. This determination is specific to the priority applicant, each active ingredient of the medicine, and the priority indication. .

It is an abridged review (a reliance pathway).

Internal business practice (milestone process) for the standard registration process aims to process submissions within a target timeframe of 220 working days. The priority registration process is designed with a target timeframe of 150 working days. *The timeframe is calculated from acceptance for evaluation through to the delegate's decision.