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Approved names for biological cell and tissue substances
TGA approved terminology for therapeutic goods
This guidance provides information on approved names for biological cell and tissue substances in biological therapies.
Approved Cell and Tissue Names (ACNs)
ACNs identify ingredients of biological origin, blood, blood components, tissue and cellular products, and tissue- and cell- based derivatives. Under TGA terminology, ACNs do not include:
- ingredients derived from plants, e.g. organisms treated as plants in the International Code of Botanical Nomenclature, including fungi, algae and yeast. Plant names are described in section 7. Approved names for herbal ingredients
- antibiotics, which are given Australian Approved Names (chemical) (AANs) (see section 4. Approved names for chemical ingredients)
- biological ingredients that are not regulated under the regulatory framework for biologicals such as vaccines, peptides and monoclonal antibodies.
Searching the list of ACNs
The Ingredients Table on our TGA Business Services website contains all approved names for ingredients used in biological therapies.
For more information on how to search for ingredients, refer to Appendix 3.1.1.
The inclusion of an ACN in the Ingredients Table:
- indicates that the name is approved as the descriptor of the substance
- does not indicate that the substance has been approved for use in a biological therapy.
If the biological cell and tissue ingredient is not on the Approved List
If there is no ACN for a biological cell and tissue ingredient for your biological:
- follow the process for proposing a new ingredient name
- use the form - Proposed Australian Approved Cell and Tissue Name (ACN).
Naming references for biological cell and tissue substances
Reference codes are included against each entry in the Ingredients Table to indicate the reference or authority that defines the biological cell and tissue substance name.
INN, USAN and ISBT 128 terminology are preferred and should be used wherever possible.
Where there is no INN or other pharmacopoeial monograph to reference, you may need to provide further information about the ingredient with an application for an ACN.
For further details, see section 3.3 Ingredient naming references.
General guidelines for naming biological cell and tissue ingredients
General guidance on naming biological ingredients is currently under development and will be published soon. For enquiries please contact the Biological Sciences Section by email: firstname.lastname@example.org.