Planned process improvements for GMP clearance in Australia

15 August 2017

As part of the Australian Therapeutic Goods Administration’s (TGA) ongoing efforts to improve its processes and guidance to industry, the regulator said today it will be publishing an updated revision of the Good Manufacturing Practices (GMP) clearance guidance document shortly.

The updated guidance aims to provide clarification of the existing requirements for the GMP clearance process. The TGA 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, it is also redesigning the current GMP Clearance application e-forms. The redesigned e-forms aim to:

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