GMP clearance Sponsor Information Dashboard (SID)
SID provides industry with regular updates about the backlog reduction, actual processing times, existing workloads, requesting prioritisation and other key messages for GMP clearance applications.
The backlog of Good Manufacturing Practice (GMP) Clearance Compliance Verification (CV) applications is continuing to reduce.
All backlog reduction strategies have been implemented and a recap has been published.
The rolling three month processing timeframes have been removed from this SID update, as the data was subject to significant fluctuation and may not provide consistent or meaningful insights for stakeholders. Processing timeframes continue to be monitored, and we are reviewing options to include more meaningful datasets in future updates.
The below data is from 1 April 2026 and will be updated every 4 to 6 weeks to ensure it remains current.
Backlog reduction progress
The graphs below illustrate the trend of GMP Clearance applications over time. Further details on actual numbers can be read from opening the drop-down menu under each graph.
Figure 1 shows the trend of the total number of CV applications in our lodgement queue over the past 12 months. The total number of CV applications steadily reduced in 2025, with a steep drop at the beginning of Q3 2025 due to the backlog reduction strategy. Since the backlog reduction strategy was introduced on 1 July 2025, the rate of reduction has also increased as expected. Since Q2 2025, the total number of applications reduced from 2,294 applications to 1,342 to date, which equates to a reduction of ~41%.
Figure 1 - Total number of CV applications pending assessment between 1 March 2025 and 1 April 2026
Figure 1 shows a line graph detailing the total number of Good Manufacturing Practice (GMP) Compliance Verification (CV) clearance applications between Q2 2025 and Q2 2026.
The vertical axis represents the total number of GMP clearance applications within the TGA’s application lodgement system.
The horizontal axis represents the date broken down by quarter and year.
The graph starts at 2,294 applications in Q2 2025 and ends at 1,342 applications in Q2 2026, illustrating a steady decrease in the backlog over the year.
Figure 2 shows the trend of applications in our CV streams over the past year with each line representing a different stream.
Both the Non-Sterile Active Pharmaceutical Ingredient (NS-API) and Non-Sterile Finished Product (NS-FP) streams are reducing as expected. The rate of reduction in the NS FP stream has increased following the allocation of additional resources, whilst both sterile streams continue to remain relatively steady.
Figure 2 - number of CV applications in lodgement by stream between 1 March 2025 and 1 April 2026
Figure 2 shows a line graph detailing the number of Good Manufacturing Practice (GMP) clearance compliance verification applications pending assessment in each stream between Q2 2025 and Q2 2026.
The vertical axis represents the total number of GMP clearance applications within the TGA’s application lodgement system.
The horizontal axis represents the date broken down by quarter and year.
There are four lines represented within the graph.
The line with a diamond marker at the top of the graph represents non-sterile active pharmaceutical ingredient compliance verification applications. This shows a sustained decrease in application numbers from ~840 to ~680 by the end of June 2025 followed by a sharp decrease to ~500 by August 2025. These numbers further decrease to ~313 by 1 April 2026.
The next line with a square marker represents non-sterile finished product compliance verification applications. The line shows a consistent decrease in application numbers from ~650 in Q2 2025 to ~457 by 1 April 2026.
The third line with a triangle marker represents sterile finished product compliance verification applications. This shows that there was a slight increase in application numbers from ~350 to ~380 between Q2 2025 and Q3 2025 but have decreased back to ~318 by 1 April 2026.
The bottom line with a circle marker represents sterile active pharmaceutical ingredient compliance verification applications. This shows that application numbers have remained relatively steady between ~170 and ~200 within the last year.
GMP clearance workload volumes
Figure 3 shows a snapshot of all GMP Clearance applications in the system at different stages of evaluation or queue categories. The largest number are 'complete' applications in lodgement queues ready for evaluation (This includes both MRA and CV application types). The total number of all applications on 1 April 2026 was 1560.
Figure 3 - total number of GMP clearance applications and the applications status as of 1 April 2026
Figure 3 shows a bar graph detailing total numbers of Good Manufacturing Practice (GMP) clearance applications and the applications status.
The vertical axis represents the number of applications.
The horizontal axis represents the status of the applications.
There are nine bars:
The first bar from the left side of the graph represents complete applications awaiting assessment, there are 798 applications represented. This is reduced from 845 in March. with more applications being picked up for evaluation.
The second bar represents assessments in progress, that is applications currently being considered by evaluators, there are 237 applications represented. This has decreased slightly from 285 in March.
The third bar represents administrative applications awaiting assessment, this includes updates for manufacturer names and addresses as well as other application types, there are 134 applications represented, a decrease by 14 applications since March.
The fourth bar represents extension, there are 85 applications represented as compared to 53 in March, an increase of 32 since March.
The fifth bar represents applications awaiting payment, there are 76 applications represented, an increase of 3 since March.
The sixth bar represents incomplete applications. There are 71 applications represented, a decrease of 2 since March.
The seventh bar represents applications awaiting receipt, there are 57 applications represented, decreasing by 7 since March.
The eighth bar represents letter of access applications, there are 54 applications represented, a decrease of 6 since March.
The ninth bar on the far right of the graph represents applications which are currently on hold (typically for GMP non-compliance investigations), there are 48 applications represented, an increase of 14 since March.
GMP clearance target processing timeframes - rolling 3 monthly data
The figures below provide an overview of the target and actual processing times for certain application types, measured in TGA working days. The actual processing time applies for 90 percent of applications completed within the last 3 months.
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30
Target MRA application processing time
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20
Actual MRA application processing time
MRA applications have been consistently processed below our target processing time. Due to the rolling nature of the SID data and the lag this creates, the actual processing times have only now reduced to approximately 20 TGA working days.
Application Quality - rolling 6-monthly data snapshot
The figures below provide an overview of how many applications required a Request For Information (RFI) or were incomplete at the time of submission.
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11 % of 310 applications
Percentage of Mutual Recognition Agreement (MRA) applications requiring an RFI
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32 % of 768 applications
Percentage of incomplete CV applications
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67 % of 768 applications
Percentage of Compliance Verification (CV) applications requiring an RFI
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29 % of 73 applications
Percentage of TGA certificate applications requiring an RFI
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75 % of 40 applications
Percentage of applications using a letter of access (LoA) requiring an RFI
Prioritisation requests
We will continue to process effective applications as quickly as possible. Medicine shortages remain a high priority for us, and we will continue to process these when sponsors have provided the required information.
Please note that we will liaise internally with the medicine shortages team to verify requests and seek additional information such as supply and market data.
For any request for prioritisation, you must provide the required information outlined below via email:
- The product name and existing ARTG number (where applicable)
- The category of medicine (Complementary, Non-prescription, Prescription etc.)
- The product submission type and submission number and any applicable milestone dates (for example, priority review pathway or NCE, PM-XXXX-XXXXX-X-X etc.)
- For variations, you need to provide information about the change as certain changes made by manufacturers may require additional GMP evaluation.
- For requests linked to reportable medicines, the medicines shortage notification number (for example MS-XXXX-XX-XXXXX-X)
- Any other information to help us understand the urgency of the situation. For example, existing stock levels or run-out dates, negative effect on patients or business etc.