,1 min read
The Therapeutic Goods Administration (TGA) in Australia has launched the Sponsor Information Dashboard (SID) — a digital tool providing transparent insights into Good Manufacturing Practice (GMP) Clearance application trends, backlog reduction, and processing timelines.
The SID was introduced to improve visibility for sponsors navigating the GMP Clearance process, which ensures that overseas manufacturing sites meet Australian GMP compliance standards before products can enter the market.
Why the Dashboard Matters
In 2024, the TGA faced a growing backlog of Compliance Verification (CV) applications, peaking at nearly 2,500. To address this, a risk-based backlog reduction strategy was rolled out on 1 July 2025. Since then, the SID has shown a steady decline in pending applications — particularly in the Non-Sterile API (NS-API) and Non-Sterile Finished Product (NS-FP) streams.
The dashboard also highlights current processing timeframes, with 50% of applications completed within 300 TGA working days. While the target remains 30 working days, the trend indicates progress toward shorter timelines as older cases are resolved.
Implications for Sponsors
For sponsors, the SID serves as both a performance tracker and a strategic planning tool. It emphasizes the importance of high-quality documentation, risk-based submission readiness, and timely communication with the TGA — especially for applications linked to medicine shortages, which receive prioritization.
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At Freyr Solutions, our Regulatory Affairs experts specialize in TGA GMP Clearance submissions, documentation management, and regulatory intelligence tracking. We help sponsors interpret SID data, streamline compliance, and accelerate market access.
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