GMP Clearance: Backlog reduction strategy commencing 1 July 2025

From 1 July 2025, we are introducing the following temporary risk-based strategies for GMP Clearance:

• Automatic extension of existing Mutual Recognition Agreement (MRA) and non-sterile Active Pharmaceutical Ingredient (API) CV GMP clearances due to expire between 1 July 2025 and 30 June 2027
• 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.

We expect these initiatives will build upon the progress that has already been made in reducing the number of applications we have on hand and improve processing times.

Automatic extension of MRA and non-sterile API GMP clearances

All existing MRA and non-sterile API CV GMP Clearances due to expire between 1 July 2025 and 30 June 2027 will be extended for a period of 2 years beyond their current expiration date.

This strategy will be delivered in two stages due to the lifecycle of GMP Clearances. Initially, all applications in our repository that are expiring within the date range will be extended. Following this, we will consider any corelating applications sitting in our lodgement queues.

Sponsors should familiarise themselves with the below key points regarding this strategy.

Extension process:

• Sponsors or Agents do not need to apply for this extension. It will be automatically applied during July 2025.
• Individual notifications will not be sent for each extension. Sponsors can view their GMP Clearance expiry dates in the TBS portal.
• A web statement will be published on the TGA website when all applications have been extended.

After extensions have been applied, corresponding applications in our lodgement queues will be processed as per the below scenarios:

• Renewal or extension applications that are no longer required will be closed. Individual notifications will not be sent for these.
• Applications with more recent evidence which, if approved, would result in a longer expiry date will be considered case by case, after the extensions are applied.
• Similarly, variation applications to increase the scope of the existing GMP Clearance approval will also be considered case by case, after extensions are applied.

Abbreviated evaluation of manufacturing sites performing certain lower risk activities

We will perform abbreviated evaluations for manufacturers performing certain lower risk activities. These may include the following types of manufacturers:

• testing laboratories
• secondary packaging and storage sites
• cell banking facilities

Ending GMP clearance regulatory flexibilities introduced during COVID-19 pandemic

For CV applications submitted from 1 July 2025, we will return to pre-pandemic business rules and no longer accept evidence from inspections conducted more than 3 years ago, including supporting documentation such as the GMP Clearance questionnaire.

This will remove one of the major contributing factors in creating the backlog and provide clear guidance on whether a GMP Clearance or GMP Certification application should be applied for.

Applications submitted prior to 1 July that provided the above documentation as evidence will continue to be evaluated. The suitability of the supporting evidence will be determined as part of the evaluation.

Progress reporting and communication

We will closely monitor the effectiveness of these strategies in assisting with reducing the backlog. Regular 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).

Webinar

We will hold a webinar and Q&A session in June 2025 prior to the implementation of these strategies. This session will provide further information on the backlog and the above strategies.

Specific dates and times will be published on the TGA website once confirmed.

Contact us

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