Preparations for Phase I trials take months longer in the US than in Australia

In the US, new drugs go through the FDA’s Investigational New Drug (IND) pathway. In Australia, new drugs use the TGA’s Clinical Trial Notification (CTN).

US pathway: CMC months 0 to 18; nonclinical 0 to 14; protocol drafting 4 to 13; protocol finalization 12.5 to 14; package compile 18 to 19.5; scientific review 19.5 to 20.5; ethics review 20.5 to 22.5; site startup 22.5 to 26.5. Australian pathway: CMC 0 to 12; nonclinical 0 to 14; protocol drafting 4 to 13; protocol finalization 12.5 to 14; package compile 12 to 14.5; scientific review 12 to 15.5 (in parallel); ethics review 14.5 to 16.5; site startup 16.5 to 18.5.

The timelines for preparing an IND application in the United States versus Australia. These timelines are representative and vary by modality. Most of the gap between a US and an Australian start arises in the pre-IND preparation phase, with CMC work accounting for the largest share. The period after IND submission then adds several more months to the US timeline, because Australia allows scientific and ethical review to proceed in parallel, and Australian sites can start enrolling patients faster.