Update on the Compliance Verification (CV) GMP clearance applications backlog

12 September 2018

The TGA continue to receive large number of GMP Clearance Applications in the previous financial years. In 2017-18 a total of 5327 GMP Clearance applications were received. This compares with over 5400 applications in 2016-17 and over 5600 in 2015-16. This has created a backlog of applications and has extended the processing times for CV clearance applications. It is also anticipated that we will likely receive similar number of CV clearance applications in this financial year. To address the backlog, in September 2017 the TGA implemented a range of GMP Clearance process improvements and a streamlined compliance verification process.

Following this implementation, we have been actively tracking the progress on the reduction of the CV clearance backlog and gathered data related to the number of CV clearance applications currently in our system.

Analysis of the CV GMP Clearance applications shows that there has been a substantial reduction in the number of CV applications across the board. Although we are still experiencing extended processing timelines, our efforts are having an impact. This is outlined in the table below.

Breakdown of CV Clearance Applications Prior to process improvement 11 Months Post Process Improvement
1 June 2017 3 Sep 2018
Total number of CV applications 1327 799
Non-Sterile APIs 663 276
Sterile/ Biotech APIs 117 81
Non-Sterile Finished Products 350 240
Sterile/Biotech Finished Products 197 176

We will continue our efforts to clear the current backlog of GMP Clearance CV applications and provide you with updates on our progress.