Request a new ingredient

There are two stages to making an ingredient available for use in a therapeutic good:

• approval of the appropriate name for the ingredient
• evaluation of the ingredient for use.

Approval of the appropriate name

Before the TGA can evaluate a new ingredient, the new ingredient must have an approved name known as an Australian Approved Name (AAN).

Proprietary ingredients are not a type of ingredient and do not need an approved name, however ingredients used within the proprietary ingredient must have approved names.

First check the Ingredients Table to see if your ingredient already has an Australian Approved Name.

You do not need to apply for a new approved ingredient name if it already has one. If you cannot locate it in the Ingredients Table, apply for a new ingredient name via Forms for new ingredient name and proprietary ingredients.

Evaluation of the ingredient

Once your new ingredient has an approved name the TGA can then evaluate the ingredient for use in a therapeutic good. This evaluation will differ depending on the type of therapeutic good you have.

Ingredients in registered medicines

The TGA registers medicines it considers as posing a higher risk. This includes prescription medicines, over the counter (OTC) medicines, registered complementary medicines and biologicals. 

Because of the higher risk posed by these medications we fully evaluate them for safety, quality, and efficacy before they can be entered onto the Australian Register of Therapeutic Goods (ARTG) and sold and supplied in Australia.

New ingredients are typically evaluated as part of the application process for the medicine to be entered onto the ARTG. We will make a scheduling proposal as part of the registration process.

See: 

• Supply a prescription medicine 

• Supply a biological 

• Supply a non-prescription medicine (for OTC and registered complementary medicines) for more detail.

Ingredients in listed and assessed listed medicines

The TGA evaluate new proposed ingredients for listed and assessed listed medicines. After we have evaluated the ingredient, it will be entered onto the permissible ingredients determination and available for use.

 See Application requirements for new substances in listed medicines | Therapeutic Goods Administration (TGA)

Ingredients in medical devices

New ingredients are typically evaluated as part of the application process to include a medical device onto the ARTG.

See Medicinal substances in medical devices | Therapeutic Goods Administration (TGA)