TGA - Consultation: Interim guideline on antimicrobial resistance risk data

Australian health officials (Therapeutic Goods Administration) are seeking comments on the following document: “Interim guideline on microbial resistance risk data for antibacterial medicinal products.”

With guidance:

·         The data that should be included with applications to register a new antibacterial medicinal product or to extend use of products already registered, as set out in the draft document is:

·         Microbial resistance safety data, including data on the propensity for promoting resistance and cross-resistance, as a basic requirement for the assessment of all new antibacterial agents.

Human antibiotic-resistance prevalence data in the Product Information.

Bacterial resistance

The hazard with regard to details of bacterial resistance patterns in relevant microorganisms in vitro may be characterised by providing: – Minimum inhibitory concentration (MIC) data of the antibacterial agent against bacterial species likely to be affected. MIC distribution data should be presented for targeted bacterial species and for relevant non-targeted bacterial species. Estimated rates of development of the expression of resistance, such as indicated from in vitro studies of passaged microorganisms in the presence of the antibacterial agent, may be included. – Details of microbial resistance patterns in relevant human isolates which have emerged with the use of the antibacterial agent, or related substances, overseas and/or in Australia should be provided when available. This would include changes identified in MICs of the antibacterial agent against isolates of bacterial species likely to be affected collected from clinical trials or from wider clinical use. The risk assessment should state whether Australian data are included and Australian data should be provided where available and recent. Interim guideline on antibacterial resistance risk data

• Data on mechanisms of resistance pathways in relevant microorganisms.
• Data on in vitro cross-resistance with other antibacterial agents in the same class in targeted and non-targeted bacterial species.

Data on co-selection of resistance by unrelated antibacterial agents

Genetics of resistance

The genetics of resistance may be characterised by providing:

• Data on resistance genes.
• Location of resistance genes (chromosomal, transferable elements).
• Data on transfer of resistance genes between bacterial species.

To access the document, see TGA

Posted by Tim Sandle