Companion diagnostics guidance update- public consultation

Closed 17 Jun 2024

Opened 15 Mar 2024

Contact

IVDs@tga.gov.au

Results updated 26 Aug 2024

Feedback updated 26 August 2024

We asked

We invited feedback on the proposed updates to the IVD companion diagnostic (CDx) guidance.

The proposed updates aim to provide sponsors and manufacturers of medicines, biologicals and IVD medical devices further clarification regarding the requirements for companion testing, including:

  • A CDx testing identification guide to assist them in identifying whether their medicine or biological indication requires companion testing,
  • An introduction to the concept of the ‘companion testing plan’ to recognise the CDx component evaluations undertaken as part of the medicine application,
  • Improved clarity on clinical and analytical performance requirements for CDx, and
  • Case studies to assist sponsors of medicines and devices on the regulatory process and the technical documentation required for an IVD CDx.

You said

We received thirteen (13) submissions.

Most respondents were supportive of the proposed updates but indicated they wanted more clarity on:

  • What TGA considers well-establised tests for the purposes of CDx identification guide
  • Location for the companion testing plan in the Common Technical Document (CTD) for medicine applications, and
  • More case studies to illustrate different scenarios.

Next steps

The TGA will consider all the feedback and incorporate the suggestions from the respondents where appropriate. The TGA will finalise and publish the updated IVD companion diagnostics guidance before the end of 2024.

Results updated 26 August 2024

Below are the individual response published in accordance with the consent provided by ten (10) of the thirteen (13) respondents.

Files:

Overview

The Therapeutic Goods Administration (TGA) is seeking your feedback on the updated draft Companion Diagnostics (CDx) Guidance document.

The proposed updates aim to provide sponsors and manufacturers of medicines, biologicals and IVD medical devices further clarification regarding the requirements for companion testing, including:

  • A CDx testing identification guide to assist them in identifying whether their medicine or biological indication requires companion testing,
  • An introduction to the concept of the ‘companion testing plan’ to recognise the CDx component evaluations undertaken as part of the medicine application.
  • Improved clarity on clinical and analytical performance requirements for CDx, and
  • Case studies to assist sponsors of medicines and devices on the regulatory process and the technical documentation required for an IVD CDx.

 

Responding to this Consultation

The draft guidance will be available for public consultation for 3 months (15 March 2024 – 17 June 2024).

Submissions in response to the consultation paper can be made through the online survey link below during this time period. You can right click on the consultation paper below and open a new tab to access the paper while going through the online survey.

 

Enquiries

Any questions relating to the consultation should be emailed to IVDs@tga.gov.au

Audiences

  • Anyone from any background

Interests

  • Health technology
  • Legislation
  • Regulatory policy