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Assessed listed medicines evidence guidelines
Version 1.1, August 2018
There are three types of complementary medicines available to consumers: listed medicines, assessed listed medicines and registered complementary medicines. These are categorised on the ingredients they contain and therapeutic indications they use. Assessed listed medicines are products that meet the eligibility criteria for listed medicines but which use indications that, while still appropriate for listed medicines, fall outside the list of Permitted Indications.
The products can only be listed in the ARTG following self-certification by the applicant of the safety and quality of the product, and pre-market assessment by the TGA of the efficacy evidence supporting the proposed indications and claims. Medicines that have undergone pre-market assessment and approval by the TGA have a unique AUST L(A) number, and may carry a claim that the product's efficacy has been assessed for the approved indications (this is currently under development).
There are three application categories for assessed listed medicines which have different evidence requirements depending on the level of efficacy evaluation (see Application Categories). This document provides guidance for the evidence requirements for all application categories, however a majority is dedicated to L(A)3 applications as these products require a de novo evaluation of efficacy.
Like all listed medicines, assessed listed medicines may only contain low risk ingredients specified in the Therapeutic Goods (Permissible Ingredients) Determination and must be produced under Good Manufacturing Practice (GMP) principles. The safety and quality of the finished products are self-certified by the applicant and are not pre-market assessed by the TGA.
Assessed listed medicines may make indications that fall outside the list of permitted indications but which are not of a type necessitating registration of the product. These 'intermediate level' indications are generally more definitive than indications on listed medicines; relate to more serious health conditions; and may lead to a delay in seeking medical treatment and/or adverse consequences for the consumer if the product is used incorrectly or is not efficacious (see Indications).
Therefore, while assessed listed medicines are considered to be low risk based on their ingredients, manufacture, and route of administration, they are considered to be of higher risk than listed medicines based on the therapeutic indications they carry. Assessed listed medicines are consequently subject to a pre-market evaluation by the TGA of the scientific evidence supporting the proposed indications before the product can be listed in the ARTG.
Only products supported by high quality scientific evidence can be accepted for assessment through the assessed listed medicines pathway. Products that have indications supported solely by animal studies, tradition of use, or anecdotal data will not be accepted.
If the TGA determines that the efficacy of the proposed product is well supported by evidence and the product meets all other requirements for listed medicines, it can be listed in the ARTG.
Benefits of the assessed listed medicines pathway
The assessed listed medicines pathway bridges a significant gap that exists between the evidence requirements, costs, and timeframes for the listed and registered medicines pathways. It provides flexibility for sponsors to access higher level indications than are currently appropriate for listed medicines, without mandating data requirements that are not commensurate with the risks. This pathway provides a market advantage to sponsors via higher level indications and a claim on labels and promotional materials; supports innovation; and encourages an expansion of the evidence base for complementary medicines.
The assessed listed medicines pathway provides significant benefits to consumers and health professionals - increasing the transparency of the evidence base for claims; improving confidence in products; enabling consumers to make more informed healthcare decisions; and facilitating greater consumer access to a wider range of evidence-based remedies to self-manage their health.