Remaking of standards and legislative instruments for human cell and tissue products, blood and blood components

We asked for feedback on proposals to remake some of the legislative instruments relating to human cell and tissue (HCT) products (including blood and blood components), which sunset in October 2021.

We received 33 submissions in response to the consultation, including from government, sponsors, industry organisations, as well as from individual consumers. There was broad support for the remaking the legislative instruments relating to human cell and tissue (HCT) products (including blood and blood components), with proposed amendments. Responses from the eye banking sector did not initially support some proposed changes.  

In addition, stakeholders provided a range of views and suggestions to improve the standard, including:

• Label requirements too onerous for biologicals not for supply in Australia.
• Introduce risk-based assessments as an alternative for HTLV serological testing for donor screening requirements.
• Donor history requirements specified in TGO 108 as burdensome for ‘export only’ plasma for fractionation (PFF).

The changes proposed in the public consultation and above referenced feedback have been incorporated in the final standards.

Some feedback was not accepted as matters either affected or were beyond scope of the quality, safety, efficacy of therapeutic goods.

Thank you to everyone who provided feedback and helped in the development of the standards.

Most changes proposed in the standards are deregulatory or the current sponsors already comply with the new requirements.

To allow sponsors to meet the quality system requirements a 12-month transition period will be allowed for all standards from 1 October 2021 to 30 September 2022.  During this time the former Orders may be conformed with, despite being repealed, as an alternative to the new standards.

The exception to this are donors whose ocular tissue will be released for supply solely for the purpose of corneal transplantation (‘cornea only donors’). TGO 108 will now mandate additional serological testing for human T cell leukaemia virus types 1 and 2 (HTLV-1/2) and syphilis, with nucleic acid amplification testing (NAT) for human immunodeficiency virus types 1 and 2 (HIV), Hepatitis C virus (HCV) and Hepatitis B virus (HBV) for these donors. An extended transition timeframe of 3 years for ‘cornea only donors’ from additional donor testing requirements in TGO108 to allow adequate time for availability of appropriate testing facilities in some states and territories.  

The new orders TGO107, TGO 108 and TGO109 come into effect on 30 September 2021.The Therapeutic Goods (Biologicals - Specified Things) Instrument 2021 also comes into effect on 30 September 2021.