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If you are developing a biological product, you need to consider the classification of your product to understand the level of supporting data required to support your application for inclusion on the ARTG.
Before classifying your biological, check that your product:
- meets our definition of a biological
- is regulated as a biological
- is not excluded from regulation
- is not exempt from certain regulatory requirements.
Classification of biologicals is based on either of the following:
- mention in Schedule 16 (Class 1 and 4 biologicals)
OR
- Method of preparation and intended use (Class 2 and 3 biologicals)
Additional criteria are used to determine exemptions.
- PageStandard pathwayInformation on the stages of preparation, and application for Class 2, 3 or 4 biologicals.
- PagePriority review pathway for biologicalsInformation on the stages of preparation, and application for Class 2, 3 or 4 biologicals using priority pathway.
More information
- Confirm your product is regulated as a biological
- What is regulated as a biological
- Australian regulatory guidelines for biologicals (ARGB)
Classification of biologicals
Application information
- Preparing your biologicals application for inclusion in the ARTG
- Biologicals application form - a step-by-step guide
- Applying for inclusion of a Class 1 biological in the ARTG
- Separate and distinct biologicals
- Pathways for supply of biologicals
Specific topics
- Biologicals packaged or combined with another therapeutic good
- Autologous human cells and tissues products regulation
- Method of preparation: Interpretation of minimal manipulation
- Intended use: Interpretation of homologous use