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Indications for Listed medicines that refer to biomarkers
Information for sponsors
Listed medicines are restricted to indications and claims relating to health maintenance, health enhancement or non-serious, self-limiting conditions.
The TGA does not mandate a particular form or set of words for indications. However, sponsors need to ensure that when utilising the free text box in the Electronic Listing Facility (ELF), indications for a listed medicine that make reference to biomarkers, do not imply that the medicine is for use in the treatment of a serious disease or condition of the kind specified in Part 2 of Appendix 6 of the Therapeutic Goods Advertising Code 2007 (TGAC).
Examples of indications that are considered acceptable
Indications in relation to cholesterol and the LDL:HDL ratio
- May assist in the maintenance of cholesterol within the normal range in healthy individuals
- May assist in the maintenance of normal/healthy cholesterol levels in healthy individuals
- May assist in the maintenance of cholesterol within the normal/healthy range in healthy individuals and improve the LDL:HDL ratio
- May assist in the maintenance of a normal/healthy LDL:HDL cholesterol ratio
- May help to reduce intestinal absorption of cholesterol from dietary sources
- May help reduce the oxidation of LDL cholesterol
Indications in relation to blood pressure
- May assist in the maintenance of normal blood pressure in healthy individuals
- May help to support normal blood pressure in healthy individuals
Indications in relation to blood lipids, blood fats and triglycerides
- May assist in the maintenance of triglycerides within the normal range in healthy individuals
- May assist in the maintenance of normal blood lipid/blood fat levels in healthy individuals
Indications in relation to blood sugar and blood glucose
- May assist in the maintenance of normal healthy blood sugar levels in healthy individuals
- May assist in the maintenance of normal healthy glycaemic controls in healthy individuals
- May assist in the maintenance of normal healthy blood sugar/glucose balance in healthy individuals
Complementary medicine reforms
As part of the TGA's response to Recommendation 2 of the 2011 report of the Auditor General on complementary medicines , the TGA is actively working on the completion of the Coded Indications project which is aimed at limiting the use of inappropriate claims and indications on the Australian Register of Therapeutic Goods (ARTG). A copy of the recommendations can be found in Appendix 1 to the document TGA reforms: a blueprint for TGA's future.
In the event that the TGA only accepts Coded Indications for listed medicines (including standardised indications for biomarkers) and/or mandates a label advisory statement, industry will be informed and there will be an appropriate transition period.
Another of the recommendations in the Blueprint document aimed at reducing the level of non-compliance by sponsors identified by the Auditor-General's report is for the TGA (in consultation with stakeholders) to update, and include in the regulations, requirements for the levels and kinds of evidence to support indications and claims. It is expected that requirements including those relating to qualifying statements for biomarkers would be clarified as part of that process.
Sponsors are reminded that they are required to hold evidence to support all indications/claims for listed complementary medicines.
For more information relating to the advertising of therapeutic goods, please refer to the TGAC.