Back

Remaking of standards and legislative instruments for human cell and tissue products, blood and blood components

This may be of interest to members.

TGA is seeking feedback on these remade legislative instruments relating to human cell and tissue (HCT) products, including blood and blood components. This includes numerous Therapeutic Goods Orders (TGOs).

The consultation paper includes:

  • remade draft standards (TGO 107, TGO 108 and TGO 109);
  • draft guidance documents¬† for TGO 107, TGO 108 and TGO 109; and
  • mapping documents tracing the sections in remade TGOs (TGO 107, TGO 108 and TGO 109) back to the current TGOs (TGO 83, 84, 85, 86, 87 and 88).

Please refer https://consultations.health.gov.au/tga/consultations-health-gov-au-tga-remake-tgos-hct-bl for further information, including how to provide feedback.

The consultation closes at 11.59pm on Sunday 11 July 2021.