Removing redundant processes for entering certain formulation information into a therapeutic goods application

Overview

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 (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.

Scope

The focus on this activity is limited to ingredient mixtures that contain an active ingredient (known as ‘Active Premixes’ and ‘Active Herbal Extracts’), and non-specific ‘Excipient Mixes’, which do not provide sufficient information on the purpose of the mixture.

Through this activity we seek to:

• improve the integrity of the data held within the TGA’s Ingredients Repository
• reduce unnecessary work for active ingredient suppliers, such as the need to submit details of their mixture to the TGA, and
• remove redundant processes that are resource intensive for TGA and industry.

The scope of this consultation paper is purposely limited to the above categories. We recognise that there have been calls for a broader review of the overall policies or processes for all categories of mixtures in the Proprietary Ingredient Table. However, the benefits and challenges associated with entering mixtures into the Proprietary Ingredients Table are different depending on the mixture’s purpose and formulation.

Please refer to Related section below for the printable Word version of this consultation.

Why we are consulting

We are seeking your views on:

• how our proposal to stop processing new Active Premixes, Active Herbal Extracts and non-specific Excipient Mixes into the Proprietary Ingredients Table would affect you
• the proposed approach for managing these types of entries previously entered into the Proprietary Ingredients Table.

We invite you to provide your feedback by completing our online survey (click on the link below).

We will consider any feedback received before a decision is made. We will also publicly announce the outcomes of this consultation and publish your responses, unless you specifically request that they be kept confidential.

Once decided, we aim to implement the proposal in the first half of 2021. The TGA’s Proprietary Ingredient processes are purely administrative. No legislative changes would be needed to implement this proposal.