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
- 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
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