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Purpose
This guidance is for manufacturers and sponsors of biologicals. It specifies the general manufacturing and quality requirements for therapeutic goods comprising, derived from or containing human cells or tissues (HCT) set out in the Therapeutic Goods (Standards for Biologicals-General and Specific Requirements) (TGO 109) Order 2021 and provides an interpretation of how the various requirements can be met
Generally, Therapeutic Goods Orders (TGOs) are standards that determine the consistency of product quality, including label quality. As an HCT product provider, you must comply with requirements that contribute to the quality and safety of HCT products, and that mitigate infectious disease risks.
TGOs are subject to automatic repeal 10 years after their registration (sunsetting). TGO 109 replaced the following TGOs:
- Therapeutic Goods Order No. 83 - Standards for human musculoskeletal tissue (TGO 83)
- Therapeutic Goods Order No. 84 - Standards for human cardiovascular tissue (TGO 84)
- Therapeutic Goods Order No. 85 - Standards for human ocular tissue (TGO 85)
- Therapeutic Goods Order No. 86 - Standards for human skin (TGO 86)
TGO 109 also includes some aspects of this TGO:
TGO 88 does not sunset until 1 October 2023 but was also updated given the crossover with the product-specific TGOs 83-86.
This information is provided for guidance only and has been developed based on current knowledge of the subject matter.
It should not be relied on to address every aspect of the relevant legislation. You should seek your own independent legal advice to ensure that all legislative requirements are met. For clarification of a particular requirement, contact TGA’s Biological Science Section (BSS).
Read this guidance in conjunction with TGO 109.