Australia’s therapeutic goods regulator, the Therapeutic Goods Administration (TGA) has announced that it is planning improvements around Good Manufacturing Practice (GMP) clearance.
As part of this, the TGA will be publishing an updated revision of the GMP clearance guidance document, and redesigning the current GMP Clearance application e-forms.
GMP clearance is required for all medicines (unless exempt) supplied in Australia. Australian based manufacturers of medicines and biologicals are required to hold a licence to manufacture, and in order to obtain a licence, the manufacturer must demonstrate compliance with the relevant code of GMP. Overseas manufacturers of medicines supplied to Australia must also meet an acceptable standard of GMP.
The updated GMP guidance aims to clarify existing requirements of the GMP clearance process. Further, the TGA has announced that in order to assist sponsors prior to them submitting GMP clearance applications, it will be publishing a new web-based tool, the GMP Clearance Application Assistance Tool (CAAT).
The redesigned e-forms will allow upfront payment of all relevant GMP clearance fees as well as allow extension requests to be submitted via the TGA Business Services GMP clearance application e-form. A number of other changes have been made to the forms to improve the user experience. These include automatically displaying the required evidence based on the application type selected, pre-populating certain sections based on details registered with the TGA and reducing the need to duplicate data entered. Improvements to the ‘help’ function within the e-forms will also assist applicants in the completion of these forms.
The TGA plans to provide information sessions in early September, explaining the improvements that will be introduced, as well as showcasing the CAAT.
The TGA is aiming to publish the revised guidance, the CAAT and the redesigned e-forms in September, and has advised there will be an outage of the GMP clearance application forms from 19 September to 26 September, during which time GMP Clearance, Licence and Certification applications will not be available.