Probiotic and gut health supplements: developing one in Australia

The quality standard: monograph 3053

The TGA treats general monograph 3053 of the European and British Pharmacopoeias, Live biotherapeutic products for human use, as the standard most relevant to probiotics. It applies to all probiotics, including multi-strain products, and requires probiotic active ingredients to be controlled at strain level.

Controlling at strain level doesn't mean testing every strain to the end of the shelf life. Where the quantity is controlled by what goes in, the TGA's material says strain identity and quantity are controlled earlier, through good manufacturing practice, including qualifying the vendor or supplier. The TGA's guidelines on demonstrating the quality of listed probiotic medicines set out what a delegate would accept, and are not mandatory.

Two other rules are different for probiotics:

• Microbial testing. TGO 100's test methods aren't applicable to medicines containing viable microorganisms, the TGA says; the methods and limits in monograph 3053 are considered more appropriate.
• Excipients on the label. Monograph 3053 asks for the name of any stabilisers and other excipients on the label. Since an amendment to the Exempt Monographs Determination in 2025, that requirement no longer applies to eligible listed medicines in Australia.

Strain names on the label

A listed medicine's label names each active ingredient by its Australian Approved Name, and for probiotics those names exist only at species level. Monograph 3053 asks for the strain. A TGA consent under section 14 let sponsors label at species level, under the labelling order, or at strain level, under the monograph, but not mix the two on one label. It ran until 1 October 2026, when TGO 92 ended. Check the TGA's current position before the artwork is final, and see our labelling guide for the rest of the label.

Holding the count to expiry

The quantity on the label has to be there on the last day of the shelf life, not only on the day it was made. Stability studies show each batch keeps at least the labelled quantity. If the evidence relies on a total count for a genus or species over time, the TGA wants additional data showing particular strains aren't out-competing the others, such as stability data for the individual strains and water activity data (stability testing).

The Belly Solution's powder has a 36-month stability program behind it, designed with the product's formula.

Formats

• Powders and pouches. The Belly Solution combines Saccharomyces boulardii, a prebiotic and electrolytes in a 14-day pouch (powders and sachets).
• A daily supplement. A skincare brand's second-version formula put probiotics at the core of a two-a-day product.

Which format suits a probiotic depends on the strains, the dose and the water in the mix, so we settle it at the brief with the stability plan.

From our records

• The Belly Solution: a TGA-listed travel gut-health powder built on the clinically studied probiotic yeast Saccharomyces boulardii, with a prebiotic and electrolytes, in a 14-day pouch. We designed the formula, built the claims evidence, secured the listing, reviewed the label and set up a 36-month stability program. About eight months from formulation to dispatch, then a national pharmacy distribution trial, with more than 30 new stockists in the first week.
• A skin program built on probiotics: the second version of a skincare brand's daily supplement, with probiotics at its core, the claims evidence, the TGA listing and a stability program. From design to production order in 12 weeks, shipped in 2025.
• Ora, our founder's own brand, has a gut health range among its practitioner medicines.