The Therapeutic Goods Administration (TGA) has released updates to its Sponsor Information Dashboard (SID), providing transparency on Good Manufacturing Practice (GMP) clearance applications, backlog reduction progress, and current processing times. This initiative ensures sponsors are informed and can plan submissions effectively.
Key highlights include:
- Backlog Reduction Strategy:
- A risk-based backlog reduction strategy for GMP Compliance Verification (CV) applications was introduced on July 1, 2025, targeting a backlog that peaked at ~2,500 applications in Q4 2024.
- The strategy has led to a steady decline in pending applications.
- Application Streams:
- Non-Sterile Active Pharmaceutical Ingredient (NS-API) and Non-Sterile Finished Product (NS-FP) streams are reducing as expected, with NS-API showing the most significant decline.
- Sterile streams (ST-API and ST-FP) remain relatively steady.
- Processing Times:
- Currently, 50% of applications are completed within 300 TGA working days.
- Target processing timeframe for most applications is 30 working days, but longer durations occur for 90% of cases.
- Prioritization:
- Applications related to medicine shortages are prioritized. Sponsors must provide detailed product information and milestone dates for prioritization requests.
- Updates and Resources:
- The SID is updated regularly to reflect changes in backlog, processing times, and application quality.
- Figures and snapshots illustrate trends in application streams and overall clearance status.
This update reinforces TGA’s commitment to transparency, efficiency, and risk-based prioritization in GMP clearance management.
Source
Select Mandate HA
Select Mandate Function