Planned process improvements for GMP Clearance
As part of the TGA's ongoing efforts to improve its processes and guidance to industry, we will be publishing an updated revision of the GMP clearance guidance document shortly. The updated guidance aims to provide clarification of the existing requirements for the GMP clearance process. We will also be publishing a new web-based GMP Clearance Application Assistance Tool (CAAT) to provide further assistance to sponsors prior to submitting GMP clearance applications.
In parallel to the above activities, we are also redesigning the current GMP Clearance application e-forms. The redesigned e-forms aim to:
- Improve the user experience by:
- Displaying a list of evidence required based on the application type selected
- Pre-populating some data using client details already registered with TGA
- Reducing duplication in data entry for applicants
- Providing an improved 'Help' function within the e-form
- Allow upfront payment of all relevant GMP Clearance fees
- Allow extension requests to be submitted via the TGA Business Services GMP clearance application e-form
We aim to publish the updated revision of the guidance, CAAT tool and the redesigned e-forms in September 2017.
We plan to hold a number of GMP Clearance information sessions in early September. These sessions will provide an update on improvements to the GMP clearance guidance, redesign of the current GMP clearance e-forms and will also showcase the new CAAT tool to provide greater assistance to sponsors prior to submitting GMP clearance applications.
What you need to do with your draft GMP Clearance applications
As a result of the updated e-forms, to ensure you don't lose existing work you will need to submit any 'draft' GMP Clearance applications using the current form, before the redesigned GMP Clearance application forms go live. You may also use the "View entire application button" to save a PDF copy of your draft application to refer to later.
On Tuesday 19th September 2017 at 9am, any existing GMP Clearance drafts not submitted will be removed and no longer visible in your tBS portal.
All GMP Clearance applications from 26th September will need to be submitted as a new application or variation application using the redesigned application forms.
To locate 'draft' applications: Login to your TGA Business Services portal, under Work in progress, select view all drafts
This will direct you to a list of all your draft applications. Enter CL as a filter on identifier and select Go.
This will display a list of any draft GMP Clearance applications. You can continue editing a draft and submit by selecting the draft you want to edit.
This will open the draft for editing, once all information is completed and the application successfully validates you can submit the application.
We would also encourage you to delete any 'draft' GMP Clearance applications which are no longer required. To do this, Click on the drop down next to the draft application you want to delete. This will bring up an option box below. Select Delete
You will be asked to confirm that you want to delete this draft. Select OK to delete.
We will provide additional updates in the near future. Please contact the Manufacturing Quality Branch if you have any questions.
We appreciate your patience and understanding while we go through this transition.