GMP Clearance compliance verification pathway: progress update

The backlog of GMP Clearance CV applications is reducing having peaked in mid-October 2024 with a total number of 2547 CV applications in our lodgement queue.

Since that time, we have seen a ~10% reduction in the total number of applications (237 applications).

This is predominantly driven by a ~23% reduction in Non-Sterile Active Pharmaceutical Ingredients (API) stream (255 applications) and a ~10% reduction in Sterile Finished Product applications (25 applications).

We anticipate the overall application numbers will continue to reduce in the coming months as new GMP evaluators progress with training. Focus will move to the Non-Sterile Finished Product stream to begin to reduce the number of these application types.

We will continue to provide updates on our progress via the Sponsor Information Dashboard and through the TGA-Industry Working Group on GMP.