1 August 2019 - In 2016, the Australian Government announced that the Therapeutic Goods Administration would establish two new pathways for the rapid approval of therapeutic advances and life-saving drugs.

These are the priority review and provisional approval pathways. The aim is to make the medicines available to the people who need them sooner than the usual regulatory process.

A drug is only eligible for a fast-track pathway if its proposed primary indication is for the treatment, prevention or diagnosis of a life-threatening or seriously debilitating condition. The drug must also represent a major therapeutic advance in safety or efficacy relative to already approved treatments. In addition to new drugs, new indications are eligible for the fast-track pathways.

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