Last updated on: 24 November 2021. See update at the end of the post.
TGA, Australia is consulting on the remaking of some TGOs and other legislative instruments for human cell and tissue (HCT) products.
What are Therapeutic Good Orders (TGOs)?
Generally, TGOs are standards that determine the consistency of product quality, including label quality.
What is the TGA seeking feedback on?
It is seeking feedback on a proposal to remake some TGOs and other legislative instruments relating to human cell and tissue (HCT) products including blood and blood components, which sunset in October 2021.
Legislative instruments are automatically repealed after a fixed period of time (subject to some exceptions). This automatic repeal is called ‘sunsetting’.
Why is the TGA seeking this feedback?
Whilst the TGOs and other legislative instruments in the proposal continue to operate largely effectively and efficiently, TGA is seeking feedback to make sure that 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
Accordingly, the TGA is proposing to remake these TGOs and the other legislative instruments under section 10 and section 32A of the Therapeutic Goods Act 1989 (the Act), respectively.
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.
Which TGOS and other legislative instruments are included in the consultation?
The TGOs relevant to this consultation can be broadly categorised into the following three groups:
- Product-specific standards:
- Labelling requirements:
- General donor selection and testing requirements:
Although TGO 88 does not sunset until October 2023, this Order cross-references TGOs 83-87 and so will be reviewed at the same time to provide clarity across these HCT-relevant TGOs.
The consultation will also consider two other legislative instruments:
- Therapeutic Goods (Things that are not Biologicals) Determination No. 1 of 2011
- Therapeutic Goods (Things that are Biologicals) Specification 2019
What are the proposed amendments?
It is proposed to remake:
- the six TGOs stated above into three TGOs shown in the table below
- the two legislative instruments shown above into the legislative instrument shown in the table below.
|Current TGO(s)||Proposed TGO||Scope of new TGO|
|TGO 87||TGO 107||All biologicals including faecal microbial transplant (FMT)|
|TGO 88||TGO 108||(a) All biologicals excluding FMT|
(b) Blood and blood components
|TGOs 83,84, 85, 86 and parts of||TGO 109||(a) Merge TGO 83-86|
(b) Transfer microbiological and critical materials requirements from TGO 88
(c) Extend some general manufacturing requirements to all biologicals
|Two legislative instruments shown above||Therapeutic Goods (Biologicals – Specified Things) Instrument 2021|
Where can you find the consultation documents?
You can view the following here:
- Consultation paper
- For each of the new TGOs, you can view:
- Proposed TGO
- Draft guidance document
- Clause by clause tracking changes
What is the commencement date for the new legislative instruments?
The commencement date of the new legislative instruments is 30 September 2021.
Where can you provide feedback?
You can provide feedback here.
What are the consultation start and end dates?
Start date: 27 May 2021
End date: 11 July 2021
Update on 24 November 2021
Following receipt of responses, the TGA has updated the information on its wwebsite.
The changes proposed in the public consultation and information from feedback have been incorporated in the final standards.
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, with some exceptions detailed here. During this time the former Orders may be conformed with, despite being repealed, as an alternative to the new standards.
The new orders TGO107, TGO 108 and TGO109 came into effect on 30 September 2021.The Therapeutic Goods (Biologicals – Specified Things) Instrument 2021 also came into effect on 30 September 2021.
Source: TGA website