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Consultation: Proposed performance requirements and risk mitigation strategies for HIV tests

6 March 2015

This consultation closed on 30 January 2015

In June 2014, the Secretary of the Department of Health signed the legislative instrument to amend the Therapeutic Goods (Excluded Purposes) Specification 2010 to allow the future supply of HIV self-tests. The effect of this amendment is that HIV self -tests can now be included in the ARTG and legally supplied in Australia, subject to satisfying the applicable regulatory requirements.

In light of the change to allow the supply of HIV self-tests, the TGA conducted a targeted consultation in December 2014 seeking comments on proposed performance expectations and risk mitigation strategies for tests used to detect HIV, particularly HIV point of care (PoCT) and HIV self-test.

The paper:

  • Proposed different performance requirements for each of the forms of HIV testing depending on the intended purpose, the experience of the user and the specimen type.
  • Identified some of the risks associated with the different forms of testing and potential conditions that may be placed on the supply to mitigate any residual risks.

The feedback received from the consultation process has assisted in the development of a guidance document for industry so that there is a clear understanding of TGA expectations with regard to performance requirements and risk mitigation strategies for HIV tests, particularly HIV PoCTs and HIV self-tests. The performance expectations for HIV tests that have already been approved in overseas jurisdictions (e.g. Canada, USA, Europe) were also taken into consideration when developing this document.

Consultation documents

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Submissions received