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Submissions received and summary: Proposal for the regulation of IVD companion diagnostics

9 July 2019

Between 23 October 2018 and 14 December 2018, the TGA sought comments from interested parties on the proposal for the regulation of IVD companion diagnostics.

Twenty-three written responses were received. We thank those individuals and organisations for their valuable feedback.

TGA summary

Submissions received in response to the consultation showed that the majority of stakeholders support the implementation of a regulatory framework for IVD companion diagnostics which is aligned with comparable overseas regulators such as the European Union (EU) and the United States Food and Drug Administration (USFDA). Most of the submissions have supported the various elements of the proposed framework including:

  • A regulatory definition of IVD companion diagnostic;
  • Confirmation that IVD companion diagnostics are class 3 IVDs;
  • The requirement for compulsory audit of all IVD companion diagnostics with the proviso that abridged assessments and reduced fees will be utilised whenever suitable evidence of prior assessment is available to the TGA;
  • The need for the TGA to recover the costs of audit assessments of IVD companion diagnostics through the charging of appropriate assessment fees;
  • Clear identification of all IVD companion diagnostics that are included on the Australian Register of Therapeutic Goods (ARTG);
  • Provisions for transition of IVD companion diagnostics which are included on the ARTG at the commencement date of the new regulations and a transition timeframe that is aligned with the transition period for the EU Regulations;
  • Regulatory requirements to apply to both commercially supplied IVDs and in-house IVDs that are companion diagnostics.

Notwithstanding the broad overall support for the proposals, several submissions contained suggestions for improvements to specific elements of the framework. This feedback will inform the final policy proposals submitted to the Government and the specific regulatory amendments that are subsequently prescribed.

Submissions received

All submissions that were not marked as confidential are now available in PDF format.

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  • Consultation submission: Illumina Australia Pty Ltd - Name and work title only

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  • Consultation submission: ThermoFisher Scientific - Name and work title only