SVA-REG-27 //Andrographis Listing Boundary

What The Signal Actually Says

TGA removed Andrographis paniculata from the permissible-ingredients framework effective September 17, 2026. New medicines containing it are no longer eligible for the listed-medicines route for supply in Australia. Existing ARTG-listed medicines can remain in supply unless or until voluntary or regulatory action changes their status. TGA strongly recommends sponsor action and says medicine-specific regulatory action will start from mid-October if timely action is not taken.^[1]

Export-only listed medicines follow a separate framework; sponsors should review the safety findings and destination-country requirements. This is not a worldwide ingredient ban or an immediate blanket withdrawal of every existing Australian product. The registered-medicines route remains distinct.^[1]

The Operating Boundary

The operating question is which release decision depends on which authorisation. A botanical specification can remain unchanged while a planned new listing becomes unavailable. Existing inventory does not automatically inherit the same status as a future SKU, and an export route is not evidence of domestic listing eligibility.

For cross-border teams, separate three files: the proposed product and route, the current listing and any action affecting it, and the export-only product with its destination requirements. Do not substitute a supplier assurance for that product-specific review.

What To Check Now

• Is this a proposed new Australian listed medicine, an existing ARTG listing, or an export-only medicine?
• Which sponsor owns the current ARTG entry, and what dated voluntary or regulatory actions affect this exact product?
• Which purchase orders and unreleased lots depend on an authorisation that may change before supply?
• For export-only stock, who has reviewed the safety finding and the importing country's requirements rather than assuming Australian listing status transfers?