Biologicals notices

2021

• Communication to stakeholders: Remaking of standards and legislative instruments for human cell and tissue (HCT) products, blood and blood components
  26 May 2021 Remaking of standards and legislative instruments for human cell and tissue (HCT) products, blood and blood componentsh

2019

• TGA regulation of faecal microbiota transplant (FMT) products in Australia
  19 Sep 2019 Position on the regulatory model for FMT products in Australia as agreed by the Minister for Health

2018

• Communication to stakeholders: Autologous human cells and tissues (HCT) products
  6 Nov 2018 Important information about potential impact of regulation changes that came in force on 1 July 2018
• Faecal Microbiota Transplant (FMT) - Outcomes from the FMT Stakeholder Forum
  29 Oct 2018 The TGA hosted a stakeholder forum in Melbourne on 10 October 2018 to confirm its understanding of the health care sector engaged in the collection, manufacture and supply of material used in FMT
• ARGB is being restructured for publication in July 2018
  3 May 2018: In preparation for the restructure of the ARGB in July, we have restructured some of the biologicals sections of the TGA website