Australia's TGA: Listed Medicines Evidence Guidelines

Earlier today (20 November, 2024) the Therapeutic Goods Administration (TGA) released Version 4.0 of its Listed Medicines "Evidence Guidelines". These guidelines provide sponsors with a roadmap to demonstrate the efficacy of listed medicines (e.g., herbal supplements, vitamins, and minerals) while maintaining compliance with Australia's regulatory framework.

Listed medicines are classified under the Australian Register of Therapeutic Goods (ARTG) as low-risk products, marked by their ARTG identification number (AUST L). They differ from registered medicines (AUST R) as they do not require individual pre-market assessment of safety, quality, and efficacy by the TGA.

However, sponsors must certify that their listed medicines:

1. Contain only pre-approved, low-risk ingredients.

2. Include permitted low-level indications (therapeutic claims).

3. Are manufactured per Good Manufacturing Practice (GMP) standards.

The guidelines outline how sponsors should compile an evidence package to demonstrate their medicine's efficacy in alignment with its indications. The evidence can derive from:

1. Scientific studies (e.g., clinical trials, systematic reviews).

2. Traditional use documentation (e.g., pharmacopoeias, monographs).

While compliance with the guidelines is not mandatory, adherence increases the likelihood of a successful TGA post-market compliance review.

The guidelines divide the evidence compilation process into five steps:

1. Find Evidence: Conduct systematic or non-systematic literature searches using databases like PubMed, MEDLINE, and Cochrane.

2. Assess Evidence: Determine its relevance to the medicine's indications and quality (e.g., minimization of bias).

3. Select Indications: Identify claims aligned with evidence type and regulatory requirements.

4. Document Evidence: Summarize findings in a critical appraisal format.

5. Submit Evidence: Present the complete package for review if requested by the TGA.

Sponsors must critically appraise the collected evidence to explain its relevance to their product’s efficacy claims. The appraisal should address potential gaps, biases, or limitations. Evidence must directly align with the product’s indications, ingredients, dosage, and target population and Discrepancies (e.g., different preparation methods) require robust justifications.

For detailed guidance, refer to the official TGA Listed Medicines Evidence Guidelines here.