TGA ~ Fast track approval pathways

Before a new prescription medicine can be available for use in Australia, the TGA assesses it for safety, quality and efficacy.

There are three pathways the TGA can use to assess a prescription medicine: the standard pathway, the priority review pathway and the provisional approval pathway.

Priority review and provisional approval are pathways that fast track prescription medicines onto the market, making them available to patients sooner than they would be under the standard pathway.

Typically, a pharmaceutical company needs many years to collect evidence that confirms the safety, quality and efficacy of a medicine by running clinical trials and doing other research. It could also take up to eleven months for us to review this evidence through the standard pathway depending on the complexity of the medicine. In the meantime, some patients with serious, life-threatening conditions could need urgent access to the medicine, but not be able to access the medicine until it is approved.

For this reason, medicines for serious or life-threatening conditions are sometimes eligible to undergo a fast track process to make the medicine available to patients sooner than normal. The sponsor must apply and the medicine must meet criteria to use a fast track pathway. For example, the medicine must be a major advance over any similar medicines that are already approved for supply.


3 pages.