The Therapeutic Goods Administration (TGA) Australia has published a guidance document for Therapeutic Goods Orders (TGO) 108 for manufacturers and sponsors of biologicals and human cell or tissue (HCT) products.
The guidance document specifies the requirements or conditions around the minimisation of transmission of communicable diseases through the use of therapeutic goods comprising, derived from or containing HCT. This is directly linked to the Therapeutic Goods (Standard for Human Cell and Tissue Products – Donor Screening Requirements) (TGO 108) Order 2021, which has been effective from 30 September 2021.
It is also important to note that TGO 108 replaces TGO No. 88, titled “Standards for donor selection, testing and minimising infectious disease transmission via therapeutic goods that are human blood and blood components, human tissues and human cellular therapy products (TGO 88)”.
TGO 108 Order 2021 contains specific information on the minimum criteria and screening requirements with regard to donor-related information, such as medical and social history requirements, testing requirements for blood and other samples, physical assessment requirements and deferral criteria.
More details can be found in “ARGB Appendix 12 – Guidance on TGO 108: Standard for Human Cell or Tissue Products – Donor Screening Requirements, November 2021”: https://www.tga.gov.au/resource/argb-appendix-12-guidance-tgo-108-standard-human-cell-or-tissue-products-donor-screening-requirements