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Communication to stakeholders: Remaking of standards and legislative instruments for human cell and tissue (HCT) products, blood and blood components
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.
Although all these legislative instruments continue to operate largely effectively and efficiently, it would be beneficial to improve clarity on some requirements as well as create efficiency through increased international harmonisation thus ensuring they continue to be fit for purpose. Accordingly, we are 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.
Please forward this information to other interested parties or providers those are likely to be affected by these changes.
The TGOs relevant to this consultation can be broadly categorised into three groups:
- Product-specific standards:
- Labelling requirements:
- General donor selection and testing requirements:
This 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
TGOs 83-87 commenced in 2011, while TGO 88 commenced in 2013. Legislative instruments are automatically repealed after a fixed period of time (subject to some exceptions) in accordance with the Legislative Instruments Act 2003. This automatic repeal is called 'sunsetting'. TGOs 83-87 are due to sunset in October 2021. 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.
Summary of proposed amendments
1. Proposed remade TGOs
It is proposed to remake the six TGOs mentioned above into the following three TGOs:
- TGO 87 will be remade as Therapeutic Goods (Standard for Biologicals—Labelling Requirements) (TGO 107) Order 2021. This order will continue to specify labelling, traceability, and accompanying information requirements consistent with current TGO 87 objectives.
- TGO 88 will be remade as Therapeutic Goods (Standard for Human Cell and Tissue Products—Donor Screening Requirements) (TGO 108) Order 2021. This order will specify donor screening requirements for minimising the risk of infectious disease transmission via therapeutic goods comprising, derived from or containing HCTs. In remaking this Order we propose to separate donor selection requirements from manufacturing, microbial and critical material requirements currently in TGO 88. It is proposed to transfer these requirements to a manufacturing-specific order, TGO 109, so that TGO 108 focuses on donor selection criteria.
- TGOs 83-86, which govern manufacture of product-specific HCTs, will be consolidated into Therapeutic Goods (Standard for Biologicals) (TGO 109) Order 2021. This order will specify manufacturing standards for biologicals, broken up into two major parts. The first part is a standard applicable to all biologicals that consists of the transferred manufacturing requirements from TGO 88. The subsequent parts specify individual manufacturing standards for the existing product-specific standards, TGOs 83-86, and an additional new standard for amnion products.
The following table summarises the remade TGOs:
|Current TGO||New TGO||Scope of new TGO||Summary of changes|
|TGO 87||TGO 107||all biologicals including faecal microbial transplant (FMT)||
(a) allow use of machine-readable codes
|TGO 88||TGO 108||
(a) all biologicals excluding FMT
(a) exempt autologous HCT products
|TGO 109||all biologicals excluding FMT||
(a) merge TGO 83-86
TGA is seeking feedback on the suitability and potential regulatory impact that any proposed amendments may have on affected stakeholders. We invite you to provide your feedback by completing our online survey on the Department of Health's consultation hub.
All responses will be published on the TGA website unless you specifically request that your response be kept confidential.
The commencement date of the new legislative instruments will be 30 September 2021, with publication of the finalised instruments beforehand.
Any transition period will be introduced where necessary and based on the outcomes of consultation.
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 making the order will be taken after submissions have been considered.
How can you get further specific advice?
If you have any queries or would like further information, please contact us.