Australian regulatory guidelines for biologicals (ARGB)

27 July 2018

The Australian Regulatory Guidelines for Biologicals (ARGB):

Pathways for supply of biologicals

If you have a product that meets our definition of a biological, Pathways for supply of biologicals will help you understand how your biological can be supplied.

Updates

ARGB updated
27 July 2018
The Australian Regulatory Guidelines for Biologicals has been restructured and updated in line with new legislative changes

TGA presentation: Changes to the regulation of autologous human cells and tissue products
20 June 2018
An overview of the changes to the regulation of autologous HCT, including guidance on restrictions to advertising content and the need to report adverse events

ARGB

Regulation basics

Classification and interpretation

Autologous human cells and tissues (HCT) products

Administrative information

Access to unapproved biologicals

  • Unapproved biologicals: pathways for access
    'Unapproved' biologicals refer to those goods that have not been included on the ARTG. Access pathways include clinical trials, special access and authorised prescriber schemes.

Applying for inclusion on the ARTG

Post-market responsibilities