Dossier requirements for Class 2, 3 and 4 biologicals

Introduction

This guidance outlines the information needed in your dossier for us to be able to effectively review your application for a biological therapeutic good.

The kind and form of information that must accompany an application for entry in the ARTG are defined in a legislative instrument under subsections 32DDA (9) and (10) of the Therapeutic Goods Act 1989.

On this page: Format of biologicals dossier | Content of biologicals dossier | Guidance on applicable standards | International reference and guidance documents | Dossier checklist | Contacting TGA

Format of biologicals dossier

Information on the format of your dossier is covered in the following sections:

• General dossier requirements which provides:
  • general information for all therapeutic goods dossiers
  • submission details for both electronic and hard copy dossiers
• Dossier structure provides an outline of the sections within the dossier for both:
  • TGA dossier structure
  • eCTD dossier structure which provides details about:
    • submitting a dossier in eCTD format
    • including a table to link the TGA dossier structure to the eCTD format.

Content of biologicals dossier

Information on the content you need to include in your dossier is covered in:

• Technical requirements
  • you need to address all sections in the dossier structure that apply to your class of biological
  OR
  • justify why a particular section does not apply to your biological.

Guidance on applicable standards

Your dossier needs to demonstrate compliance with applicable standards, including product-specific orders. To assist you when compiling your dossier we suggested you consider our recommendations detailed in:

• Guidance on TGO 107: Standard for Biologicals - Labelling Requirements
• Guidance on TGO 108: Standard for Human Cell or Tissue Products - Donor Screening Requirements
• Guidance on TGO 109: Standards for Biologicals-General and Specific Requirements
• Guidance on TGO 105: Standards for faecal microbiota transplant (FMT) products
• guidance on the applicable standards which indicate where specific clauses are to be documented in your dossier.

International reference and guidance documents

We have provided information on national and international reference and guidance documents to assist you with specific aspects of your application. Such references are not intended to introduce any requirements additional to the applicable standards.

Dossier checklist

The information contained within your dossier:

• must demonstrate compliance with all relevant product-specific and default standards (if applicable)
• is to be formatted according to the headings listed under Dossier structure
• is to address all headings listed in the dossier structure
• is to address and justify if a particular section of the dossier does not apply to your biological
• is to include evidence of manufacturer's licence or clearance.

We have outlined the type of content we expect you to address in each section to provide us sufficient information to evaluate your submission. We recognise that due to the diversity of biologicals, not all sections outlined may apply to all applications.

Contacting TGA

If there are any questions, or if clarification is required in relation to this guidance on the dossier requirements for a biological, please contact us.