The Therapeutic Goods Administration (TGA) has this week published new guidelines to help ensure the quality of listed probiotic medicines. This is a major milestone for the complementary medicines sector—outlining standards for probiotic manufacturers, suppliers, and sponsors, while offering consumers greater confidence in the products they buy.

Why the guidelines matter

Probiotics are live microorganisms (often called ‘good bacteria’) that can support various aspects of health when consumed in adequate amounts. With so many probiotic products on the market, ensuring consistent quality and effectiveness is crucial. The new TGA guidelines outline how to verify strain identity and viable bacteria counts, and demonstrate that products meet the necessary standards for shelf-life and labelling.

Key updates in the guidelines include:

• Flexible ways to verify the quality and quantity of probiotic strains, allowing for standard assay methods when certain other methods aren’t practical.
• Clarifications around labelling to ensure consumers receive accurate information about what’s in their supplements.
• Recognition that not all global testing methods are currently available in Australia, acknowledging the evolving science and leaving room for ongoing developments.

CMA’s ongoing advocacy

Behind the scenes, CMA has been actively advocating for guidelines that strike the right balance between maintaining rigorous quality standards and supporting an innovative, thriving industry. Over the past few years, CMA has led discussions with TGA representatives, coordinated consultation sessions with industry members, and provided detailed submissions to guide the TGA’s approach.

We brought together TGA officials and industry experts at a manufacturing facility to discuss technical aspects of probiotic quality and testing. We also facilitated multiple public and targeted consultations to give voice to concerns around labelling, stability testing, and real-world manufacturing practices. And CMA partnered with the International Probiotics Association (IPA), ensuring expertise from global industry leaders shaped the final guidelines.

Thanks to this collaborative work, the newly published guidelines include important clarifications, particularly on how to handle multi-strain products, supplier verification, and alternative testing methods—issues that directly impact the broader complementary medicines community.

What happens next?

The TGA acknowledges there may be future refinements to the guidelines as science and industry best practices continue to evolve. CMA will remain in close dialogue with the TGA to address any inconsistencies or gaps in the current version of the guidelines, especially around labeling requirements and testing for multi-strain probiotic products.

Additional guidance for supplier qualification is also anticipated from the TGA later this year. CMA will continue representing industry needs in technical working groups to help shape these updates.

Looking ahead

For consumers, these guidelines highlight Australia’s commitment to high-quality, evidence-based complementary medicines. For the industry, they provide a roadmap on how to demonstrate quality, ensuring safe and effective probiotic products on the market.

At CMA, we are dedicated to championing a robust, consumer-centric complementary medicines sector. As the guidelines evolve, we will be at the forefront, working to refine and improve the standards that underpin our industry—so that everyone, from raw material suppliers to end consumers, can benefit from the full potential of probiotics.