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Dossier requirements for Class 2, 3 and 4 biologicals

Australian Regulatory Guidelines for Biologicals (ARGB)

27 July 2018

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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.

Format of biologicals dossier

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

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:

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.

If you have questions or need clarification about the dossier requirements please contact us.

We recommend you request a pre-submission meeting to facilitate the compiling and subsequent submission of your dossier.

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.

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