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July 2026Australia’s Therapeutic Goods Administration (TGA) has issued guidance explaining how it monitors listed medicines after they enter the market through post-market compliance reviews.
Listed medicines are included on the Australian Register of Therapeutic Goods (ARTG) without full pre-market evaluation, based on sponsor certification that they meet section 26A requirements and low-risk criteria.
To ensure ongoing compliance, the TGA conducts both targeted and random reviews. These may assess product labels, evidence supporting claims, ingredients, manufacturing details, and sponsor obligations.
If non-compliance is identified, the TGA may require corrective actions such as label updates, evidence submission, product cancellation from the ARTG, or market recalls, depending on consumer risk.
The guidance reinforces sponsor accountability and supports the integrity of Australia’s listed medicines framework by addressing repeated, serious, or systemic non-compliance.
Source: https://www.tga.gov.au/resources/guidance/understanding-listed-medicines-compliance-reviews
Region: Australia
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