The TGA have updated their GMP clearance Sponsor Information Dashboard (SID) to provide an update on the GMP backlog reduction strategies recently implemented.
TGA’s graphs confirm that the backlog for GMP Compliance Verification (CV) application is continuing to reduce, with a decrease seen in applications for both Non-Sterile Active Pharmaceutical Ingredient (NS-API) and Non-Sterile Finished Product (NS-FP) streams, as expected, with both Sterile streams remaining relatively steady.
Whilst timeframes for actual processing times remains high (currently 50% of all applications are completed within 338 TGA working days), the TGA confirm that as they return to a steady state, the overall timeframes should also reduce.
For further details, please visit the TGA webpage: https://www.tga.gov.au/products/regulations-all-products/manufacturing/gmp-clearance-sponsor-information-dashboard-sid