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Donor screening tests: information requirements

15 October 2012

Important dates

Manufacturers who currently supply biologicals under a manufacturing (GMP) licence are required to have their products included in the Australian Register of Therapeutic Goods (ARTG) by 31 May 2014 under the new regulatory framework for biologicals.

Sponsors of currently supplied biologicals are encouraged to submit their applications, which include product dossiers, prior to 30 November 2012 under special transition arrangements.

Information about donor screening tests

Manufacturers and sponsors of biologicals:

• must ensure the current mandatory donor infectious disease screening tests are performed, as outlined in the Code of Good Manufacturing Practice for Human Blood and Tissues (August 2000)
• should include, at minimum, in the biological dossier:
  • details of currently performed donor testing, including information on the donor screening tests and methods;
  • details of service contracts with testing laboratories, if applicable;
  • existing validation data for in-house¹ donor screening tests.

Dossier requirements for donor testing of biologicals are detailed in section 4.1 of Appendices 1, 2 and 3 of the Australian Regulatory Guidelines for Biologicals.

Tests used in the manufacture of a biological may be evaluated by the TGA in regard to:

• the suitability of the test for the intended purpose
• the test manufacturer's claims
• validation data supporting the use of an in-house test.

The inclusion of a donor screening test in a biological dossier is not equivalent to TGA approval for an in vitro diagnostic (IVD) medical device. IVDs supplied in Australia for donor screening purposes are subject to separate requirements under the new IVD regulatory framework.

¹ In-house tests are developed within an Australian medical laboratory, or used for a purpose other than the intended purpose assigned by a commercial manufacturer. For further information see guideline on Regulatory requirements for in-house IVDs in Australia.

Changing donor screening tests

Sponsors should not delay submitting biologicals applications to the TGA because of any concerns about potential changes in donor screening tests, such as a change in the supplier of the test.

If the change in donor screening test is to occur after the biological is in the ARTG, the sponsor can submit an application to vary the ARTG entry. Funding of the direct regulatory costs for Australian publicly funded facilities and not-for-profit hospital supply units continues until 31 May 2014 and includes variation fees.

If the change in donor screening test is to occur before TGA approval of the original application to enter the biological in the ARTG, sponsors should contact the TGA.

Further information

Further information on dossier requirements for biologicals and the tests required for donors of all human blood, cell, and tissue products are provided in the Australian Regulatory Guidelines for Biologicals.

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