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TGA vs Industry time for GMP clearance applications
We receive a large number of GMP Clearance (CV) applications on an annual basis. Since the introduction of the redesigned application e-forms in September 2017, we are able to accurately capture the quality of applications received. This indicates that approximately 40% of all Compliance Verification (CV) applications are incomplete.
Historically, significant efforts were made to contact applicants and request them to provide the outstanding evidence, which involved several rounds of correspondence before it was provided to us for assessment. This significantly contributed to the creation of a backlog of applications and led to extended processing times for CV's. To address this, we implemented a range of GMP Clearance process improvements and a streamlined compliance verification process which has resulted in a substantial reduction of the backlog.
In order to further improve the efficiency and transparency of the GMP Clearance process, and to ensure that applicants who provide complete applications are not disadvantaged, we have started to accurately capture the processing times of CV applications by consistently applying our stop clock process throughout the entire application and not just during the assessment stage.
This flowchart is an overview of the steps 8, 9 and 10 of the GMP Clearance CV process.
Additional information can be found in steps 8-10 of the GMP Clearance Guidance.
The flow chart shows the application being submitted from the TGA Business Services portal. Once the application is submitted it is not available for us to access until all fees have been paid. During this time the application status will be displayed as 'submitted'. The application processing time has not started at this point.
Once your fees have been paid, processing time (TGA time) will commence. TGA time is defined as the number of TGA working days between the receipting process and the finalisation of your CV application; it does not include industry time. Industry time is when a stop clock is applied in the following instances:
- Awaiting payment: During receipting stage, where applicable fees were not selected during the submission of your application using the CV pathway, we will raise the invoice and you will receive a notification to pay the relevant fees by the specified due date. A stop clock will be applied to your application.
- Assessment queue incomplete applications: During receipting stage, if we have not received all the evidence required, a stop clock will be applied and the application will be identified as incomplete. Applicants will not be contacted regarding evidence requirements at this stage and incomplete applications will experience significant delays.
- Waiting on evidence: During the assessment stage, where deficiencies are identified and/or further clarification is required from the applicant, you will be sent one request with a specified due date to provide this information. A stop clock will be applied to your application until you address the request.
To determine whether a stop clock has been applied to your application, please login to your TGA Business Services portal, and view the current status of your application. If the status on your application is 'with manufacturer', a stop clock has been applied.
To avoid a significant increase in enquiries to the GMP Clearance mailbox, sponsors should contact their manufacturers in the first instance to ensure the required evidence has been provided.
Once you have contacted your manufacturer, if there are still queries in relation to the stop clock, please contact us.
This information will be included in the next revision of the GMP Clearance guidance.