Consultation: Remaking of standards and legislative instruments for human cell and tissue (HCT) products, blood and blood components

This consultation closed on Sunday 11 July 2021.

The Therapeutic Goods Administration (TGA) conducted a public consultation 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.

The TGOs relevant to this consultation can be broadly categorised into three groups:

• Product-specific standards:
  1. TGO 83: Standards for human musculoskeletal tissue
  2. TGO 84: Standards for human cardiovascular tissue
  3. TGO 85: Standards for human ocular tissue
  4. TGO 86: Standards for human skin
• Labelling requirements:
  5. TGO 87: General requirements for the labelling of biologicals
• General donor selection and testing requirements:
  6. TGO 88: 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

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

For more information on the proposals, and to participate in the consultation, please visit the consultation hub.

Timetable

The consultation opened on Thursday 27 May 2021. Interested parties responded by close of business Sunday 11 July 2021.

Enquiries

For enquiries relating to the consultation paper or your submission please email bloodandtissues@health.gov.au.