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Consultation: Interim guideline on antimicrobial resistance risk data

7 November 2014

This consultation closed on 19 December 2014

The TGA sought comments from interested parties on any part or all of the proposed Interim guideline on antimicrobial resistance risk data.

Consultation documents

How to access a pdf or Word document

Timetable

Documents released for consultation on Friday 7 November 2014.

Interested parties responded by close of business Friday 19 December 2014.

Feedback will be released following consideration of submissions. (See 'What will happen').

About the consultation

The proposed Interim guideline on antimicrobial resistance risk data is intended to assist sponsors of antibacterial medicinal products prepare information required in CTD Module 1, Antibiotic resistance data, on resistance data for new antibacterial medicines, extensions of indication to currently registered antibacterial medicines, and updated data for currently registered antibacterial medicines.

The TGA proposes to make the Interim guideline on antimicrobial resistance risk data available on the TGA website Standards & guidelines for prescription medicines.

Background

The draft TGA Guideline on antibacterial resistance risk data was prepared in 2007 and is available on request from TGA to assist sponsors of antibacterial medicines provide data to address recommendations in the Report of the Joint Expert Advisory Committee on Antibiotic Resistance (1999) and the Commonwealth Government Response to the Report of the Joint Expert Technical Advisory Committee on Antibiotic Resistance (2000), the JETACR Report.

The proposed Interim guideline on antimicrobial resistance risk data is an updated version of the draft guideline issued in 2007 and is intended to be made widely accessible via the TGA website Standards & guidelines for prescription medicines.

The proposed Interim guideline differs from the draft (2007) version in the following ways:

  • Terminology, formatting and references have been updated where required;
  • Guidance is included on provided pharmacovigilance data and information relating to microbial resistance.

The proposed Guideline is described as an 'interim' guideline because the requirements set out in it are intended to align with relevant policies set by the Australian Government, which may be amended from time-to-time.

Content of submissions

Submissions may address any part or all of the information in the Interim guideline on antimicrobial resistance risk data and may include suggested improvements or clarifications to the proposed information.

What will happen

All submissions will be placed on the TGA Internet site unless marked confidential or indicated otherwise in the submission cover sheet (see Privacy information).

Submissions will be reviewed by the TGA and feedback on submissions will be provided through the TGA Internet site.

Privacy information

The TGA collects your personal information in this submission in order to:

  • contact you if the TGA wants to seek clarification of issues raised in your submission or to check whether you consent to certain information that you have provided being made publicly available.
  • help provide context about your submission (e.g. to determine whether you are an individual or a director of a company or representing an interest group).

The TGA will disclose your name and (if applicable) your designation/work title on the TGA Internet site (i.e. make this information publicly available) if you consent to the publication of your name on the TGA Internet site (please complete the cover sheet).

Any text within the body of your submission that you want to remain confidential should be clearly marked 'IN CONFIDENCE'.

Please do not include personal information about other individuals in the body of your submission. Personal information in this context means information or an opinion about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion.

Enquiries

Any questions relating to submissions should be directed to Dr John Donohoe, Head, Knowledge Management, Office of Medicines Authorisation, by email to john.donohoe@tga.gov.au.