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An overview of human cell and tissue products

Information about how therapeutic goods move through the regulatory lifecycle from early product development to post-market.

If you're planning to bring a human cell and tissue (HCT) product to market in Australia, this is your starting point. 

You must understand how we regulate these biologicals and your obligations at each stage. This includes selecting the correct classification, preparing evidence, and complying with applicable standards such as donor screening. 

Being well-prepared helps ensure your product meets Australian requirements and avoids regulatory delays. 

Start by learning about your responsibilities and planning each stage of your product’s lifecycle. 

You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to biologicals. You may also have to meet obligations that apply to all biologicals and all products.

General information

Learn about how products are regulated.

Definitions and classification

Understand how products are defined and classified.

Ingredients and scheduling

Get information about ingredient approvals and scheduling requirements.

Legislation, Acts and Orders

Review the laws and legal orders that regulate therapeutic goods.

Standards and requirements

Understand product obligations for safety, quality and efficacy.

Product types