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International Collaborative Review Initiative

18 September 2019

Following the success of the Australia-Canada-Singapore-Switzerland (ACSS) Consortium work-sharing initiative for evaluation of new prescription medicines, other regulatory agencies have engaged with the TGA regarding collaboration initiatives.

Recently, the TGA and HC entered into a collaborative review with the US FDA. This review was an extension of indication application for a combination treatment under the provisional approval pathway (preliminary clinical data where there is the potential for a substantial benefit to patients).

Through increased international collaboration, regulators can achieve greater harmonisation, reduce regulatory burden, and enable more timely access to new treatments.

The downstream public health benefits are a main focus for international collaboration, and the TGA-HC-FDA collaborative review has been an important step forward to facilitate a more harmonised and globalised regulatory system.

The TGA will continue to encourage and grow these international partnerships noting the positive experiences and outcomes that they bring to all countries.