GMP Clearance: backlog reduction strategy recap and next steps

On 1 July we introduced the GMP Clearance backlog reduction strategy which comprised of:

• The automatic extension of existing Mutual Recognition Agreement (MRA) and non-sterile Active Pharmaceutical Ingredient (API) CV GMP clearances that were due to expire between 1 July 2025 and 30 June 2027
• Commencing abbreviated evaluation of manufacturing sites performing certain lower risk activities
• Ending GMP clearance regulatory flexibilities introduced during COVID-19 pandemic, specifically the GMP Clearance Questionnaire.

All strategies have now been implemented, and the backlog is reducing at the expected rate. The GMP Clearance Sponsor Information Dashboard (SID) has also been refreshed with more data and insights. Ongoing progress reporting will be communicated on this page.

Automatic extension of MRA and non-sterile API GMP clearances

Between 1-10 July, we extended over 6200 GMP Clearances. Since then, we identified 887 correlating applications in our lodgement system. 430 of these were no longer required and were closed. 

The remaining applications either have more recent evidence available, which would provide a longer expiry date than the automatic extension, or are seeking an increase in scope. These applications will be processed as normal over the coming months. 

Abbreviated evaluation of manufacturing sites performing certain lower risk activities

Abbreviated evaluations have commenced for certain manufacturing sites. This process will continue throughout the reduction of the backlog.

There are no changes to the evidence requirements for GMP Clearance applications at this stage.

Ending GMP clearance regulatory flexibilities introduced during COVID-19 pandemic

On 1 July we removed the GMP Clearance Questionnaire from the TGA website and no longer accepted it as a form of application evidence.

To date there have been no major issues with evidence availability for applications as global GMP inspection levels continue to return to normal.

We continue to encourage Sponsors to engage with their manufacturers and ensure the available evidence they hold meets our requirements. Where the evidence does not meet our requirements, Sponsors should submit a Certification application.

Progress reporting and communication

We will continue to monitor the effectiveness of these strategies in reducing the backlog. Ongoing progress updates will be published on the GMP clearance Sponsor Information Dashboard (SID) and shared with industry peak bodies through the TGA-Industry Working Group on Good Manufacturing Practice (GMP) (TIWGG).

Contact us

For any questions about the backlog reduction strategy, please contact GMPclearance@health.gov.au.