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Ingredient basics

8 October 2020

There are two types of ingredients:

  • An active ingredient is a therapeutically active component in a medicine's final formulation.
  • An excipient ingredient in a medicine's final formulation that is not a therapeutically active component. For example, preservatives, tablet coatings or ingredients that contribute to fragrance or flavour. Excipients are also found in other types of therapeutic goods. For example, preservative media for tissues, adhesives in devices, preservatives in ultra sound gels or fragrances in disinfectants.

All ingredients used in therapeutic goods need an agreed name to ensure:

  • the name clearly and explicitly identifies the ingredient
  • only one name is used to specify an ingredient (to avoid confusion)
  • consistency of ingredient names with international conventions e.g. International Non-proprietary Names (INNs).

Approved names

Therapeutic goods in Australia must use 'approved names' in their formulations. All the currently approved names can be found in the Ingredients Table in TGA Business services.

If an ingredient name is not included in the Ingredients Table, applicants can propose a new name for approval. For more information about proposing a new name see the TGA approved terminology for therapeutic goods and the forms for new ingredients page.

Proposals for new names are considered by experts with TGA and approved based on naming conventions described in the TGA approved terminology for therapeutic goods document. We determine the most appropriate name and naming reference for the ingredient. The name and the reference help ensure that the substance can be clearly identified.

Once a name is agreed upon, it is approved and included in the Ingredients Table in TGA Business services.