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Target processing timeframes for Compliance Verification (CV) GMP clearance applications

11 June 2019

We continue to experience a high demand for GMP Clearance applications which significantly impacts our resources and processing timeframes.

In September 2017, we introduced a range of GMP Clearance process improvements and a streamlined compliance verification process. Following this implementation, we have been actively monitoring the reduction of the back-log and in September 2018 we provided an update of our progress.

As we have been progressing with clearing the back-log, we have also been continually improving our processes to ensure we do not risk a return to back-log in future. Among these have been the recent updates in January 2019 on TGA vs Industry time and the stop-clock process.

Following consultation with the TGA Industry Working Group on GMP (TIWGG), the need to provide industry with predictable target processing times for CV applications was agreed.

As such, for CV applications submitted from 1 July 2019, the following processing times will apply:

Application type Target processing timelines
CV Non-Sterile API 60 TGA working days
CV Sterile/Biotech API 75 TGA working days
CV Non-Sterile Finished Product 90 TGA working days
CV Sterile/Biotech Finished Product 120 TGA working days

In April 2017 after the reduction of the MRA GMP Clearance back-log, we amended the MRA target processing time from 15 to 30 working days in order to reflect the current volume of applications received and the impact it had on the processing time that was developed in 2011.

Similar to the above MRA timeframe, it should be noted that these are maximum timeframes and we will continue to aim for the shortest possible processing time for each application.

We will also continue to monitor and review our processing times and will publish any changes on our Notices about GMP Clearance webpage.

This information will be included in the next revision of the GMP Clearance guidance to be published around the end of June.

Enquiries and feedback

Should you require any further clarification about this process, please contact us at: GMPclearance@health.gov.au.