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Australian Regulator On The Highs & Lows Of Project Orbis

 
• By Ian Schofield

The US FDA-led initiative for collaborative submission and review of new cancer drugs has produced a number of benefits since it was introduced in 2019, including more “robust” regulatory decisions and earlier market access, the DIA Europe 2022 conference heard. 

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Project Orbis uses concurrent reviews to speed new cancer drugs to market • Source: Shutterstock

The Project Orbis collaborative oncology drug review program has “exceeded our expectations” in terms of encouraging earlier regulatory submissions in Australia, although some challenges remain with regard to issues such as review processes, resources and choice of submission pathway, says a senior official at the country’s Therapeutic Goods Administration.

The TGA has completed 33 submissions under Project Orbis so far, of which 11 have been new molecules and 22 new indication applications

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