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

Closed 11 Jul 2021

Opened 27 May 2021

Feedback updated 29 Sep 2021

We asked

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.

You said

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.

We did

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  During this time the former Orders may be conformed with, despite being repealed, as an alternative to the new standards.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.




Published responses

View submitted responses where consent has been given to publish the response.


The Therapeutic Goods Administration (TGA) is seeking feedback on a proposal 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 are seeking feedback to make sure the proposed changes:

  • improve clarity on technical requirements
  • ensure alignment with international best practice and standards
  • bring legislation into alignment with recent amendments, including updates to autologous HCT requirements

Consultation documents

These documents contain the background of the change, the proposed remake and proposed guidance.

You will need to read these documents before submitting your response.

Consultation paper

TGO 107 - Biologicals labelling requirements

TGO 108 - HCT products donor selection requirements

TGO 109 - Standard for biologicals

Legislative instrument - Biologicals specified things

Why your views matter

The Orders are important to provide clarity, and to specify Australian-specific donor screening, labelling and manufacturing requirements for therapeutic goods comprising, derived from or containing human cell and tissue products, including blood and blood components to ensure their quality and safety for Australian patients and consumers.

We are seeking feedback from stakeholders on the suitability and potential impact of the remade TGOs (107, 108 and 109) and the merged legislative instrument.

Making a submission

1. Read the consultation documents about the proposed changes, and the reasoning on why we propose the change (links above). 

2. Go to the online consultation questions, complete and submit your response (link below)

What happens next

Submissions will be reviewed by the TGA and a summary of the submissions will be posted on this website. A decision about remaking the TGOs will be made after submissions have been considered.

Sponsors of existing HCT products will be required to submit a single notification for included biologicals to confirm their ongoing compliance after these TGOs are remade.


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