Permissible Ingredients: the third determination of 2026 and the andrographis removal

The Therapeutic Goods (Permissible Ingredients) Determination is the TGA's list of the ingredients a listed medicine can use, with the purposes and limits each one is used within. It changed twice in a month. On 17 September 2026 an amendment removed Andrographis paniculata from the list. On 16 October 2026 the Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2026 commenced, repealing and replacing No. 2, with five new ingredients and a changed requirement for one probiotic.

Andrographis is off the list

The amendment removed Andrographis paniculata from the determination from 17 September 2026. The TGA's reason is the risk of anaphylaxis: its explanatory statement says the "life-threatening risk of anaphylaxis associated with Andrographis cannot be effectively mitigated" and that warning labels alone don't manage it. Reports of anaphylaxis had reached 317 by 31 July 2026.

A medicine containing andrographis can no longer be listed. The explanatory statement says such a product can still be entered on the Register as a registered medicine, which goes through a full pre-market evaluation. The TGA ran a targeted consultation from 8 April to 8 May 2026 and received 29 submissions; most of the industry and practitioner responses opposed removal and proposed stronger labels, dose limits or practitioner-only supply, and the TGA found those suggestions didn't change its conclusion.

What No. 3 of 2026 adds

The third determination of the year commenced on 16 October 2026. Its explanatory statement lists five new ingredients for listed and assessed listed medicines:

• magnesium L-threonate monohydrate
• mitoquinol mesilate
• gamma glutamylcysteine
• styrene/isoprene/styrene block copolymer
• hydrocarbons, C6-C20, polymers, hydrogenated

It also varies the requirements for Bacillus coagulans, makes minor amendments for Bacillus subtilis and Akkermansia muciniphila to reflect the end of a transition period for their requirements, and corrects typographical errors, including in the entry for Terminalia ferdinandiana (Kakadu plum). The TGA consulted the applicants for the five new ingredients and the Bacillus coagulans variation directly, over periods that ran from 2025 into 2026; the other changes weren't consulted on because they don't affect existing medicines.

What it means for a product in development

The list has moved three times this year. Three things follow for a formula.

• Check every ingredient against the current determination, by name. The entry sets the purpose an ingredient can be used for, its limits and any requirements, such as a label statement. An ingredient that isn't on the list needs its own application and evaluation before any product using it can be listed, and the consultation periods above ran from nine months to over a year.
• Check it again before the listing is lodged. A formula settled months before lodging can be caught by a change in between. We check every ingredient, its form and its dose at the brief, and once more before the listing, so nothing has to be designed twice.
• Watch the ingredients the TGA has consulted on. The andrographis removal followed a consultation in April and May and commenced in September. A consultation is the signal to plan a reformulation, not the commencement date.

The Permissible Ingredients Determination is one of the steps in our TGA listing guide, and the listed-medicines pathway shows where it sits in a project.

Sources

General information, checked against these sources on 21 October 2026. It isn't advice on a particular product.

• Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2026 and its explanatory statement, Federal Register of Legislation
• Therapeutic Goods (Permissible Ingredients) Amendment (Removal of Andrographis Paniculata) Determination 2026 and its explanatory statement, Federal Register of Legislation