TGA Australia updates guidance on regulatory requirements for companion diagnostics (CDx)

The Therapeutic Goods Administration (TGA), the Australian regulatory authority, has updated its guidance on the regulatory framework for in vitro diagnostic (IVD) companion diagnostics (CDx), with the latest version published on May 13, 2025.

This guidance applies to sponsors of medical devices and drugs/biologics, establishing the criteria for the clinical and analytical evaluation of CDx, as well as the submission, classification and approval processes within the Australian framework (ARTG). Specific requirements for commercial CDx and CDx developedin-house in clinical laboratories are also addressed.

The guidance covers aspects such as:

• Regulatory definition of CDx in Australian legislation;

• Clinical and analytical performance requirements;

• Companion testing plans (4 options);

• Post-approval conditions and updating of indications;

• Integration with medicines subject to approval;

• Illustrative case studies for different scenarios (commercial, in-house, testing abroad).

This document aligns with international requirements (EU/FDA) and provides a clear roadmap for manufacturers and sponsors looking to place CDx on the Australian market, ensuring safety, efficacy and regulatory compatibility.

See the full document below.