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2 min read
The Therapeutic Goods Administration (TGA) has recently released critical updates to its GMP Clearance Sponsor Information Dashboard (SID), signaling a major shift in how Good Manufacturing Practice (GMP) compliance is managed in Australia.
For sponsors, understanding these updates can make all the difference in achieving timely market entry and maintaining compliance.
Here are 12 frequently asked questions our regulatory experts at Freyr Solutions are hearing, and how you can stay ahead of the curve.
1. What is the Sponsor Information Dashboard (SID)?
TGA’s SID is an online tool providing real-time updates on GMP Clearance performance, including backlog reduction, processing timeframes, and application quality. It helps sponsors track regulatory trends and anticipate review timelines.
2. Why was a backlog reduction strategy introduced?
By the end of 2024, the TGA GMP Clearance backlog peaked at nearly 2,500 Compliance Verification (CV) applications. To manage this, the TGA introduced a risk-based backlog reduction strategy on 1 July 2025, designed to streamline assessments and prioritize higher-risk or high-need products.
3. Has the backlog actually reduced?
Yes. The latest SID update (as of 7 October 2025) confirms a steady decline in pending applications, particularly in the Non-Sterile API (NS-API) and Non-Sterile Finished Product (NS-FP) streams.
4. Which application streams remain steady?
While non-sterile applications are reducing, both Sterile API (ST-API) and Sterile Finished Product (ST-FP) streams remain relatively unchanged, reflecting the complexity and additional review requirements in these categories.
5. What are the current TGA processing times for GMP clearance?
Currently, 50% of applications are completed within 300 TGA working days, although the target remains 30 working days. The TGA expects timelines to shorten as older applications are cleared.
6. How does TGA prioritize applications?
Medicine shortage–related applications receive priority review. Sponsors must provide detailed product information, justification, and key milestone dates to qualify for prioritization.
7. What data does the SID provide to sponsors?
The dashboard displays rolling 6-month data snapshots on application quality, backlog progress, and target processing times — allowing sponsors to align submission strategies with current regulatory performance.
8. How frequently is the data updated?
The SID data is refreshed every 4–6 weeks, ensuring sponsors have up-to-date visibility into TGA’s processing and backlog reduction metrics.
9. What does this mean for sponsors preparing applications?
Sponsors must focus on data completeness, GMP evidence quality, and timely responses to avoid delays. Early preparation and proactive engagement remain key success factors.
10. How can companies manage competing priorities during clearance?
As TGA balances older and new applications, sponsors should adopt structured regulatory intelligence tracking and submission planning to minimize risk and delay.
11. How do these updates align with global GMP expectations?
The TGA’s risk-based approach aligns with global GMP standards and is designed to enhance predictability and transparency across regulated markets.
12. Where can sponsors get expert guidance?
With evolving timelines and prioritization rules, sponsors can benefit from dedicated regulatory experts who understand TGA submission nuances and GMP compliance strategy.
Partner with Freyr : Your Trusted Regulatory Affairs Experts
At Freyr Solutions, our Regulatory Affairs and Quality Assurance specialists have extensive experience in TGA GMP Clearance submissions, documentation readiness, and risk-based compliance strategies.
Whether you’re managing multi-site manufacturing approvals or seeking prioritization for critical medicines, Freyr helps you stay compliant, confident, and competitive.
Have more TGA GMP questions?
Let Freyr’s experts guide you through every step of your GMP Clearance journey.
