Australia’s TGA is Accelerating Drug Approval: What Pharma Needs to Know
Australia's Therapeutic Goods Administration (TGA) is rapidly transforming its drug registration landscape, positioning the country as one of the most agile environments for pharmaceutical market entry. The primary goal is clear: ensure faster patient access to life-saving therapies without compromising safety standards. Australia’s Evolving Drug Registration Pathways The TGA has introduced several key accelerated pathways to drastically cut down the standard 255-day review timeline. The Priority Review Pathway fast-tracks essential medications for unmet needs, targeting a review period of just 150 working days. For promising new drugs with early clinical data, the Provisional Approval Pathway grants short-term, time-limited registration, allowing early market access while requiring ongoing confirmatory data. These provisionally approved medicines are flagged with a distinctive black triangle (▼) for heightened post-market monitoring. A major driver of this speed is global alignm...