TGA - Therapeutic Goods Administration

01/13/2021 | News release | Distributed by Public on 01/12/2021 18:07

Consultation: Proposal to remove redundant processes for entering certain formulation information into a therapeutic goods application

This consultation closes on 24 February 2021.

The Therapeutic Goods Administration (TGA) is seeking feedback on a proposal to streamline how information about certain therapeutic goods formulations is entered into TGA electronic systems when seeking market approval.

Specifically, we propose to discontinue entering certain types of formulations into a subordinate database of ingredient mixtures (known as the Proprietary Ingredients Table) before they are selected into therapeutic goods applications for inclusion in the Australian Register of Therapeutic Goods[1] (ARTG).

Under this proposal there would be no change to how a medicine is evaluated, or to the ingredient information that is displayed on labels or in the public summaries of medicines on the ARTG.

We invite you to provide feedback on our proposal using our online survey which is available through our consultation hub(link is external).