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

We asked for feedback on a proposal to streamline how we enter information about the formulations of therapeutic goods into TGA electronic systems when an applicant is seeking market approval. To help make the application process more efficient, we proposed to stop entering three categories of formulations into a subordinate database of ingredient mixtures (known as the Proprietary Ingredients, or PI Table) before they are selected into an application onto the Australian Register of Therapeutic Goods (ARTG).

This proposal was 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.

Under the proposal there would be no change to how medicine and other therapeutic goods applications are evaluated or the amount of information publicly available about these therapeutic goods.

We received 14 submissions in response to the consultation. The majority of respondents supported the proposal to cease processing new Active Premixes, Active Herbal Extracts and non-specific Excipient Mixes into the PI Table, some stating that it was a sensible removal of redundant administrative processes, provided greater transparency and streamlining of administrative processes, was consistent with red tape reduction, and would reduce regulatory burden. However, there was concern about what expectations there would be for sponsors of existing ARTG entries that already use PI numbers within their formulation, i.e. whether existing ARTG entries would need to be updated and any cost implications. Many respondents also noted that sponsors can experience difficulties in obtaining formulation information from ingredient suppliers.

Some respondents requested a broader review of the administrative PI notification process, noting that there are broader issues associated with the use of PI numbers in formulations of medicines on the ARTG.

We appreciate all the feedback received and considered all responses before making a decision about this activity.

Based on our consideration of the issues raised in this feedback, we have agreed to stop processing notifications for new ingredient mixtures with an active ingredient or a non-specific purpose into the Proprietary Ingredients Table as of 20 July 2021. This means that no new PI numbers will be allocated to these types of formulations. Ingredient suppliers can still sell these mixtures to sponsors intended for use in medicines, but sponsors will need to select the individual ingredients into their application at the same time as they enter the rest of their medicines’ formulation details.

To help maintain the currency of information in our Proprietary Ingredients Table, we will also be inactivating (i.e. ‘hiding’) historic PI numbers for these types of mixtures where the ingredient mixture:

• is not linked to current ARTG entries, and
• was entered into the Proprietary Ingredient Table prior to 1 July 2020.

We will write to ingredient suppliers to advise them where we propose to inactivate their PI numbers, as part of our standard process for inactivating historic PI numbers that are not linked to current ARTG entries.

To address concerns raised about what impact this proposal may have on existing ARTG entries that use the affected PI numbers within their formulation we are:

• Keeping existing PI numbers active in the Proprietary Ingredient table if the ingredient mixture is included in current ARTG entries.
• Not requiring sponsors to make changes to existing ARTG entries, unless they choose to do so. In this case the sponsor can choose to correct the formulation of their ARTG entry, using existing variation processes.
• Updating relevant information on TGA website to support sponsors and suppliers in managing the change.

For more information see Streamlining proprietary ingredient categories.

In response to the call for a broader review of the administrative proprietary ingredients system, this activity is not expected to address the wider-scale challenges associated with use of PI numbers in ARTG entries. There are various categories of mixtures within the Proprietary Ingredients Table. The benefits and challenges associated with entering mixtures into the Proprietary Ingredients Table are different depending on the mixture’s purpose and formulation. Consequently, we propose to approach these challenges in a targeted and step-wise manner.