GMA
Removal from the Permissible Ingredients Determination follows a safety review, particularly of severe allergic reactions; the registered-medicines pathway remains available.
The Therapeutic Goods Administration removed Andrographis paniculata from the Permissible Ingredients Determination with effect from 17 September 2026. New medicines containing the ingredient can therefore no longer enter the ARTG through the listed-medicines route.
The decision follows a safety review that examined the risk of severe allergic reactions. For products already listed, the TGA said it would recommend voluntary action, including cancellation or recall, while reserving further measures where required.
Removal does not end every potential route to the ingredient. The registered-medicines pathway remains available and requires individual assessment of safety, quality and efficacy. For industry, the broader signal is the value of post-market data and risk management throughout the product life cycle.
The case shows how pharmacovigilance and a safety dossier can rapidly change market access and the commercial value of an established botanical.
The measure concerns Australia’s listed-medicines framework. It is not a global ban, and products already on the register were not automatically removed from sale.
Editorial note. This content is intended for industry professionals. It does not constitute medical advice, therapeutic guidance or regulatory advice. Read our editorial method.
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