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CTD Module 1

3 August 2020

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1.12 Antibiotic resistance data

Overview

Module 1.12 holds the antibiotic resistance data for new antibacterial medicines, extensions of indication to currently registered antibacterial medicines, and updated data for currently registered antibacterial medicines.

Summary of requirements

Documentation
Section Description Category 1/COR report-based Variations to quality only (e.g. Category 3)
New registration Variation New registration Variation
1.12 Antibiotic resistance data requirement defined by the regulatory activity requirement defined by the regulatory activity

When to include antibiotic resistance data

Module 1.12 applies to:

  • both topical and systemic antibacterial medicines
  • combination products containing antibacterial medicines
  • composite packs that contain one or more antibacterial medicines.

It is recommended applicants review the adequacy of data relating to the potential of an antibacterial medicine to promote resistance and cross-resistance for applications:

  • for new antibacterial medicinal products
  • that will extend use of currently registered antibacterial medicinal products
  • to change the Australian product information to include updated antibiotic resistance data.

How to prepare antibiotic resistance data

The risk assessment of microbial resistance consists of the following steps:

  • hazard characterization
  • exposure characterization
  • impact characterization
  • risk characterization.

The risk assessment may be qualitative in part, although quantitative data should be provided where possible.

It is acceptable for this document to refer to data supplied elsewhere in the dossier. References need to include module, tab identifier, and page number.

Note:

Include any Australian human antibiotic-resistance prevalence data in the pharmacology section of the Australian product information document.

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