Priority review pathway: prescription medicines

As part of the Government's response to the Review of Medicines and Medical Devices Regulation (MMDR review), the TGA has implemented a priority pathway for the registration of novel prescription medicines for Australian patients.

In summary

The priority pathway provides a formal mechanism for faster assessment of vital and life-saving prescription medicines. The target timeframe of 150 working days is up to three months shorter than the standard prescription medicines registration process.

What medicines are eligible for the priority registration pathway?

A determination process is used to assess whether a medicine is eligible for the priority pathway but does not necessarily mean that the medicine will be approved after evaluation and registered in the Australian Register of Therapeutic Goods (ARTG).

The eligibility criteria for priority determination are designed to ensure that only medicines providing the most benefit to patients are eligible. Priority review is based on a full dossier and substantial evidence. The eligibility criteria are:

• New prescription medicine or new indications medicine
• Serious condition; and
• Comparison against registered therapeutic goods; and
• Major therapeutic advance.

Please see our guidance on the eligibility criteria for priority determination for more information.

What are the benefits of the priority registration pathway?

The Priority registration pathway provides:

• consumers and health professionals with faster access to new medicines for serious and life-threatening conditions
• alignment with other overseas regulators that offer expedited pathways for prescription medicines
• a predictable and transparent mechanism to formalise the expedited process for sponsors and TGA business areas

Applications for the priority registration pathway

Sponsors must first apply for a priority determination before lodging a registration application.

For more information on the application process, see our guidance for sponsors on the Priority determination process and registration process.

The implementation arrangements provide more information on how we implemented the pathway from 1 July 2017 and our schedule for review.

Please continue to check our website for updates.