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Assessed listed medicines evidence guidelines

Version 1.1, August 2018

17 August 2018

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The assessed listed medicines pathway, established following the Government's acceptance of Recommendation 39 of the Medicines and Medical Devices Regulation review, provides sponsors with a new method of listing a product in the Australian Register of Therapeutic Goods (ARTG). The new pathway sits between the current listed (lower risk) and registered (higher risk) pathways. It enables sponsors to list products with higher level indications than permitted in standard listed medicines without having to meet the extensive requirements for full registration. This is provided that assessed listed medicines have robust scientific evidence to support the efficacy of the product, and this evidence is pre-market assessed by the TGA.

This guidance applies to 'assessed listed medicines' that are eligible for evaluation by the TGA's Complementary and Over-the-counter Medicines Branch (COMB). As this is a new pathway, we will continue to refine this guidance as necessary.

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