Biologicals regulation

Regulation basics

• What is regulated as a biological
  Understand our definition of a biological and how they are regulated
• Pathways for supply of biologicals
  Supply pathways differ for products regulated as biologicals depending on whether they are exempt, 'unapproved' or included on the ARTG
• Biologicals packaged or combined with another therapeutic good
  Understand the regulatory requirements when a biological is supplied with another product
• Glossary
  Definitions of terms used throughout the ARGB and TGA website

Classification and interpretation

• Classification of biologicals
  All biologicals must be classified before being included on the ARTG
• Method of preparation: Interpretation of minimal manipulation
  The method of preparation influences classification and whether autologous HCT products are eligible for exemptions
• Intended use: Interpretation of homologous use
  The intended use influences classification and whether autologous HCT products are eligible for exemptions
• Request for TGA advice on classification
  Form to assist with classification of your biological product and to complete when requesting advise on classification from us

Autologous human cells and tissues (HCT) products

• Autologous human cells and tissues products regulation
  Risk-based regulatory approach and criteria for exemptions and exclusions criteria
  • Excluded autologous human cells and tissues
    Exclusion criteria with examples of products likely to be excluded
  • Exempt autologous human cells and tissues
    Exemption criteria and the regulatory requirements that still apply
• Regulation of platelet-rich plasma (PRP), platelet-rich fibrin (PRF) and conditioned serum
  These products are usually considered blood components and regulated as medicines, not as biologicals

Faecal Microbiota Transplant (FMT) products

• Faecal Microbiota Transplant (FMT) product regulation
  All FMT products are regulated as biologicals.