Australia Says Yes To Using Assessments Reports From Key International Regulators
Prescription medicines could be approved faster in Australia after the Therapeutic Goods Administration issued an initial list of overseas agencies whose assessments reports it is prepared to rely on.
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Ipsen’s tyrosine kinase inhibitor, Cabometyx, is the first product to be registered under a new Australian procedure that aims to get prescription drugs to market faster by using medicine assessments already conducted by comparable overseas regulators.
Australia has outlined its plans for building up regulatory capacity and work-sharing among medicines agencies at the regional and global level in the next financial year.
Experts* conducting a landmark review of Australia's healthcare products regulatory framework are calling on the government to introduce an expedited approval pathway for medicines in certain circumstances1,2.