GMP Clearance: backlog reduction strategy progress update

We have extended all Mutual Recognition Agreement (MRA) and Non-Sterile Active Pharmaceutical Ingredient (API) Compliance Verification (CV) GMP Clearances, which were expiring between 1 July 2025 and 30 June 2027 for a period of 2 years. In total, we have processed 6258 extensions, and individual notifications were not sent for each extension. 

Sponsors can view their GMP Clearance expiry dates in the TGA eBusiness Service portal. If you believe a GMP Clearance should have been extended but is not updated on your portal, contact us at GMPclearance@health.gov.au

Next steps

We will now start processing corresponding applications in our lodgement queues as outlined in our GMP Clearance backlog reduction strategy. If more recent evidence is available, please provide this information before we evaluate the corresponding applications. Otherwise, they will be processed using the information currently on file.

If you have applications that are no longer required, please consider withdrawing them from the system. This will help us identify applications that can be closed more easily.

Webinar recording available

We held a webinar on 19 June 2025 providing further information about the backlog reduction strategy. The recording is now available.

For any questions relating to the backlog reduction strategy, contact us at GMPclearance@health.gov.au.