1 August 2018 - In Australia, like the rest of the world, patients and their doctors have a growing desire to access new drugs as soon as possible. 

They hope to make an impact on conditions with limited pharmacotherapeutic options, such as cystic fibrosis and rare cancers like mesothelioma. New approaches to more common diseases, such as lung cancer and dementia, may offer greater efficacy or less toxicity than current therapies. The pharmaceutical industry is also hungry for expedited drug approvals as a vehicle to reward and encourage innovation. Faster approvals may increase company profits as products get to the market more rapidly.

In 2015, new drug approvals in Australia by the TGA took a median of 391 days from application, which compares favourably with Europe at 478 days. However, the US FDA approves new drug applications faster than any other country at a median of 304 days. There is a paucity of published data in any jurisdiction on how any accelerated drug approval mechanism reduces the time frame for availability compared to traditional evaluation processes. The FDA aims to review a priority application within six months as opposed to 10 months under standard review.

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