You are here

Approved names for biological ingredients (not cells and tissues)

TGA approved terminology for therapeutic goods

30 March 2020

This guidance provides information on approved names for biological ingredients in therapeutic goods.

Approved Biological Names (ABNs)

ABNs are used to identify ingredients of biological origin (other than antibiotics) derived from human, animal or microbiological sources.

Under TGA terminology, ABNs do not include:

Searching the list of ABNs

The Ingredients Table on our TGA Business Services website contains all approved names for ingredients used in therapeutic goods.

For more information on how to search for ingredients, refer to Appendix 3.1.1.

Please note

The inclusion of an ABN in the Ingredients Table:

  • indicates that the name is approved as the descriptor of the substance
  • does not imply that the substance has been approved for use in a therapeutic good.

If the biological ingredient is not on the Approved List

If there is no ABN for a biological ingredient for your medicine:

Naming references for biological ingredients

Reference codes are included against each entry in the Ingredients Table to indicate the reference or authority that defines the biological substance name.

Please note

INN terminology is preferred and is to be used wherever possible.

Where there is no INN or pharmacopoeial monograph to reference, you may need to provide further information about the ingredient with the application for an ABN.

For further details on references, see section 3.3 Ingredient naming references.

General guidelines for naming biological ingredients

A wide range of substances have been identified as ABNs in the Ingredients Table.

In some instances, common names have been chosen as these are more readily understood, e.g. 'honey bee venom'. The Latin binomial species name is then included as a synonym, e.g. 'Apis mellifera venom'.

All microorganisms must be named using the Latin binomial species name, e.g. Streptococcus salivarius.

In the past, ABNs have been used to identify some products. For example, 'pertussis vaccine' (a product) was historically an ABN. This approach is no longer in place. In this example, the approved name for the ingredient is the ABN Bordetella pertussis.

Referring to animal species

ABNs for animal-based ingredients should use the scientific name, not the common animal name.

For example:

  • bovine (cow)
  • ovine (sheep)
  • canine (dog)
  • feline (cat)
  • porcine (pig)
  • equine (horse)

The common name (cow, etc.) can be included as a synonym to improve searchability of the Ingredients Table.

Naming specific types of biological ingredients

Naming microorganisms

Microorganisms are generally identified to species level. Subspecies and biovar names are only included where proven to be therapeutically relevant.

To avoid proliferation of multiple strain names, the strain reference can only be used in the ingredient name if identification of an individual strain:

  • is therapeutically relevant
  • if therapeutic activity is exclusive to the particular strain
  • can be otherwise justified.

Information about strains may be included as additional information in an entry in the Ingredients Table. Medicine labels can include strain information, as long as this information is presented in accordance with the relevant labelling order.

Naming animal parts and preparations

To provide an accurate description of animal derived substances, the approved name for biological ingredients will incorporate

  • part,
  • preparation,
  • source details

rather than as adjunct names (as is done for herbal ingredients).

Bovine cartilage powder and snake venom powder are examples of ABN ingredients of animal origin.

Transmissible Spongiform Encephalopathies (TSEs)

The animal source and part is information that we use to evaluate the safety of the substance with respect to transmissible spongiform encephalopathies (TSEs). The animal source and part will not be used separately as names in their own right.

Further information on our TSE policy (and which ingredients are eligible for self-assessment) can be found in Transmissible Spongiform Encephalopathies (TSE): TGA approach to minimising the risk of exposure.

Ingredients of animal origin to be used in listed medicines

For TSE safety, new ingredients of animal origin that are used in listed medicines must be pre-cleared before they can be added to the Ingredients Table.

For further information, refer to the Australian Regulatory Guidelines for Complementary Medicines.

Naming biological ingredients of human origin

If a biological substance is of human origin, the origin of the substance is not specified in the name.

For example, the ABN 'calcitonin' refers to the human protein, whereas 'porcine calcitonin' and 'salmon calcitonin' are obtained from pigs and salmon respectively.