Summary
Amends the Therapeutic Goods (Charges) Regulations to modify fee structures for therapeutic goods evaluation, registration, and related services provided by the Therapeutic Goods Administration (TGA). The instrument covers application fees, evaluation fees, and annual charges for goods included on the Australian Register of Therapeutic Goods.
Reason
The TGA's approval timelines for pharmaceuticals and medical devices are already among the slowest in the developed world, with new drug approvals routinely taking 2-3 years longer than comparable jurisdictions. These charges fund a regulatory apparatus that restricts consumer access to life-saving treatments, inflates costs through compliance burden, and creates barriers to entry that advantage established incumbents over innovative competitors. The true cost of this regulatory regime extends far beyond the charges collected—it includes foregone health outcomes, delayed access to therapies, and deterred market entry. Removing this instrument would eliminate one component of the compliance cost layer, and more fundamentally, would increase political pressure to rationalise the costly and time-consuming approval processes the charges fund.