Australian regulatory guidelines for biologicals (ARGB)

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

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.

Administrative information

• TGA Business Services: getting started with the TGA
  Introduction to TGA online services for sponsors, agents and manufacturers
• Drafter and submitter guidance: using TGA business services for applications
  A guide to some of the features of TGA Business Services used by drafters and submitters of applications
• Fees and charges summary
  Current fees and charges

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

• Preparing your biologicals application for inclusion in the ARTG
  Understand what you need to do before submitting an application for inclusion of a biological on the ARTG
• Separate and distinct biologicals
  Determine whether your products are separate and distinct biologicals and if they require separate entries on the ARTG
• Dossier requirements for Class 2, 3 and 4 biologicals
  Understand what to include in your dossier to submit with your application
• Applying for inclusion of a Class 2, 3 or 4 biological on the ARTG - a step-by-step guide
  How to prepare and submit an application
• Applying for inclusion of a Class 1 biological on the ARTG
  Process for Class 1 biologicals to be included on the ARTG
• Biologicals application form - a step by step guide
  Accessing and completing the application form to include or vary a biological on the ARTG
• Manufacturing biologicals
  Understand the different manufacturing principles that apply to different kinds of biologicals, the licensing requirements and your responsibilities
• Risk management plans for biologicals
  Understand the risk management system required to identify, characterise and minimise a product's risks
• Consent to import, supply or export therapeutic goods that do not comply with standards
  From 1 July 2020, a fee applies for the processing of applications for consent for biologicals under section 14 the Therapeutic Goods Act 1989

Post-market responsibilities

• Post-market responsibilities (biologicals)
  Activities that must be maintained after approval to supply a biological
• Varying biological entries on the ARTG
  For changes to matters that would have been relevant to the initial decision to include the biological in the ARTG, you need to request and receive our approval
• Notifications for included biologicals
  Certain changes may be made to an ARTG entry through the notification process where quality, safety and efficacy are not affected
• Adverse event reporting and biovigilance responsibilities
  Understand mandatory reporting and record-keeping requirements
• Uniform recall procedure for therapeutic goods
  The uniform recall procedure for therapeutic goods (URPTG) applies to biologicals
• Advertising guidance for businesses involved with stem cells and other human cell or tissue (HCT) products
  This guidance is to assist providers of stem cells and other human cell and tissue (HCT) products regulated as biologicals (including sponsors, manufacturers, importers, pharmacists, health professionals and marketers) in complying with the therapeutic goods advertising restrictions
• Australian regulatory guidelines for advertising therapeutic goods
  Understand the advertising restrictions that apply to biologicals and autologous HCTs
• Exceptional release of biologicals included on the ARTG
  Release on non-conforming biologicals is only permitted under prescribed circumstances and for an individual patient

Below are links to guidance on each of the product-specific standards to assist you in ensuring your products conform with the relevant standards.

• ARGB Appendix 10: Guidance on TGO 105: Standards for faecal microbiota transplant (FMT) products
• ARGB Appendix 11: Guidance on Therapeutic Goods (Standard for Biologicals - Labelling Requirements) (TGO 107) Order 2021
• ARGB Appendix 12: Guidance on Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Screening Requirements) (TGO 108) Order 2021
• ARGB Appendix 13: Guidance on Therapeutic Goods (Standards for Biological - General and Specific Requirements) (TGO 109) Order 2021