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Consultation: Proposal for the regulation of IVD companion diagnostics

30 November 2018

This consultation closed on 14 December 2018.

The TGA sought comments from interested parties, including clinicians, patients and industry, on the potential impacts of the proposals outlined in the consultation paper. The feedback received will assist in developing a proposed framework for Ministerial approval.

Consultation documents

How to access a pdf or Word document


Documents released for consultation on Tuesday, 23 October 2018.

Interested parties should respond by close of business Friday, 14 December 2018.

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

About the consultation

The TGA is seeking feedback from clinicians, patients and industry that will assist in developing a final proposal for Ministerial approval for the future regulation of In Vitro Diagnostic (IVD) companion diagnostics.


Rapid developments in "precision medicine" have been driven by increasing availability and affordability of tests for biomarkers which characterise patients and their disease or condition. New therapies can be rationally designed based on that information and the use of these targeted therapies is critically dependent on the accuracy and reliability of the associated "IVD companion diagnostics". As a consequence, it is important for the safe and effective use of targeted therapies that IVD companion diagnostics are appropriately evaluated in conjunction with the associated medicine or biological.

The existing IVD regulatory framework does not ensure adequate evaluation of IVD companion diagnostics in conjunction with the associated therapeutic products.


Submissions may address any, or all, of the questions posed in the consultation document or other identified issues.

In addition, submissions might include:

  • Suggested improvements
  • An assessment of how the proposed change will impact on you.
  • What do you see as the likely benefits or costs to you (these may be financial or non-financial). If possible, please attempt to quantify these costs and benefits. This is important - the TGA is required to quantify the regulatory impact (burden and/or savings) of any proposed changes.


Any questions relating to submissions should be directed to the Director, IVD Reforms Section by email to .

What will happen

All submissions will be placed on this website unless marked confidential or indicated otherwise in the submission form (see Privacy information).

Submissions will be reviewed by the TGA and feedback on submissions will be provided through this website.

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).
    • seek feedback about how the consultation was undertaken.
  • 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.
  • More information on consultations and privacy is included in the submission form and on our website.