ARGB quick links

Classification & regulation

• What is regulated as a biological?
• Autologous human cells and tissues (HCTs) products regulation
  • Excluded autologous human cells and tissues
  • Exempt autologous human cells and tissues
• Classification of biologicals
  • Method of preparation: Interpretation of minimal manipulation
  • Intended use: Interpretation of homologous use

Supply of biologicals

• Unapproved biologicals: pathways for access
• Applying for inclusion of a Class 2, 3 or 4 biological on the ARTG
• Manufacturing biologicals

Post-market requirements

• Varying biological entries on the ARTG
• Reporting an adverse event
• Initiating a product recall or hazard alert
• Australian regulatory guidelines for advertising therapeutic goods