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Fast track approval pathways for prescription medicines

20 June 2019

The Australian Government has put into place systems that allow early availability of certain potentially lifesaving prescription medicines for Australian citizens.

The purpose of the fast track approval pathways is to get prescription medicines that treat serious and life-threatening conditions to patients earlier than normal.

Examples of serious and life-threatening conditions include cancers, stroke, HIV and some rare inherited disorders.

We have implemented two new processes that will enable us to fast-track the availability of certain medicines:

Enables us to approve some medicines up to three months earlier than normal.  The evidence reviewed is the same as the standard process, but we plan for a sooner decision.

Allows us to approve some prescription medicines for a limited period of time while more information about them is collected. The TGA will only do this where the benefit of earlier access may outweigh the risk of still collecting more data about the medicine.