Site notifications

Sub menu

 

 

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.

Last updated

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 below data is from 1 November 2025 and will be updated every 4 to 6 weeks to ensure it remains current.

Backlog reduction progress

The graphs below provide an overview of 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 peaked at around 2500 in Q4 2024 and has since steadily reduced. The steep drop at the beginning of Q3 2025 was due to the backlog reduction strategy.

From 1 October 2025 to 1 November 2025 overall application numbers continue to reduce.

Figure 1 – total number of CV applications pending assessment between 1 July 2024 and 1 November 2025

Figure 1 – total number of CV applications in lodgement between 1 July 2024 and 1 November 2025

Figure 1 shows a line graph detailing the total number of Good Manufacturing Practice (GMP) clearance applications between Q4 2024 and Q4 2025.

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.

Starting at ~2500 applications in Q4 2024, the line steadily declines, reaching ~1700 applications by 1 November 2025.

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 whilst both sterile streams continue to remain relatively steady.

Figure 2 - number of CV applications in lodgement by stream between 1 July 2024 and 1 November 2025

Figure 2 - number of CV applications in lodgement by stream between 1 July 2024 and 1 November 2025

Figure 2 shows a line graph detailing the number of Good Manufacturing Practice (GMP) clearance compliance verification applications pending assessment in each stream between Q4 2024 and Q4 2025.

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 ~1080 to ~760 by the end of June 2025 followed by a sharp decrease to ~550 by August 2025. These numbers further decrease to ~420 by 1 November 2025.

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 Q2 2025 from ~830 to ~670 by 1 November 2025.

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 ~390 to ~420 between Q4 2024 and 1 September 2025 but have decreased to ~380 by 1 November 2025.

The bottom line with a circle marker represents sterile active pharmaceutical ingredient compliance verification applications. This shows that there was a slight decrease in application numbers from approximately ~250 to ~230 between Q3 2024 and 1 November 2025.

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. Due to a recent focus in application screening, the number of applications ready for assessment remains steady, with a significant reduction in those waiting to be receipted. The total number of all applications on 1 November was 1909.

Figure 3 - total number of GMP clearance applications and the applications status as of 1 November 2025

Figure 3 - total number of GMP clearance applications and the applications status as of 1 November 2025

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 eight bars:

The first bar from the left side of the graph represents complete applications awaiting assessment, there are 1040 applications represented.

The second bar represents assessments in progress, that is applications currently being considered by evaluators, there are 258 applications represented.

The third bar represents applications awaiting receipt, there are 65 applications represented.

The fourth bar represents administrative applications awaiting assessment, this includes updates for manufacturer names and addresses as well as other application types, there are 146 applications represented.

The fifth bar represents incomplete applications, there are 110 applications represented.

The sixth bar represents letter for access applications awaiting assessment, there are 80 applications represented.

The seventh bar represents extension applications awaiting assessment, there are 91 applications represented.

The eighth bar represents applications awaiting payment, there are 80 applications represented.

The ninth bar on the far right of the graph represents applications which are currently on hold, there are 39 applications represented.

GMP clearance current processing timeframes

Figure 4 shows the current percentile range for actual processing times for each CV stream, measured in TGA working days. Each bar is divided into percentiles, which represent the percentage of applications completed within a certain number of days. For example, the 50th percentile means half of the applications were completed in that time or less.

The percentiles build on each other - for example, the 50% mark includes all applications completed within the 10% and 25% ranges as well. It is expected these percentiles will continue to fluctuate as we complete older applications from the system and manage competing priorities. As we return to a steady state, requests for prioritisation should reduce and the overall timeframes should also reduce.

Currently 50% of all applications are completed within 338 TGA working days.

Figure 4 - percentages of CV applications completed within TGA working days

Figure 4 - percentages of CV applications completed within TGA working days

ST FP: sterile finished product applications
ST API: sterile active pharmaceutical ingredient applications
NS FP: non-sterile finished product applications
NS API: non-sterile active pharmaceutical ingredient applications

Figure 4 shows a bar graph detailing percentages of Good Manufacturing Practice (GMP) clearance compliance verification applications completed within specified TGA working days.

The vertical axis represents the compliance verification application streams.

The horizontal axis represents the number of days taken by the TGA to complete applications.

There are four bars, the first bar from the bottom of the graph represents non-sterile active pharmaceutical ingredient compliance verification applications. This shows that:

  • ten percent of applications are completed within 70 days,
  • twenty five percent of applications are completed within 220 days,
  • fifty percent of applications are completed within 300 days,
  • seventy five percent of applications are completed within 460 days and
  • ninety percent of applications are completed within 550 days.

The second bar represents non-sterile finished product compliance verification applications. This shows that:

  • ten percent of applications are completed within 205 days
  • twenty five percent of applications are completed within 270 days
  • fifty percent of applications are completed within 400 days
  • seventy five percent of applications are completed within 490 days and ninety percent of applications are completed within 570 days

The third bar represents sterile active pharmaceutical ingredient compliance verification applications. This shows that:

  • ten percent of applications are completed within 50 days
  • twenty five percent of applications are completed within 130 days
  • fifty percent of applications are completed within 225 days
  • seventy five percent of applications are completed within 450 days and ninety percent of applications are completed within 550 days

The fourth bar represents sterile finished product compliance verification applications. This shows that:

  • ten percent of applications are completed within 200 days
  • twenty five percent of applications are completed within 290 days
  • fifty percent of applications are completed within 400 days
  • seventy five percent of applications are completed within 600 days and ninety percent of applications are completed within 660 days

GMP clearance target processing timeframes

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.

  • 30

    Target MRA application processing time

  • 27

    Actual MRA application processing time

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.

  • 7 % of 986 applications

    Percentage of Mutual Recognition Agreement (MRA) applications requiring an RFI

  • 35 % of 932 applications

    Percentage of incomplete CV applications

  • 59 % of 932 applications

    Percentage of Compliance Verification (CV) applications requiring an RFI

  • 35 % of 106 applications

    Percentage of TGA certificate applications requiring an RFI

  • 68 % of 38 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.

Featured notices

Related resources

Product types
Topics