We will have limited operations from 15:00 Wednesday 24 December 2025 (AEDT) until Friday 2 January 2026. Find out how to contact us during the holiday period.
You must comply with regulatory requirements when manufacturing human cell and tissue products.
The procurement, collection or manufacture of human tissue or human cell products must be compliant with Good Manufacturing Practice (GMP) and meet product standards to ensure their quality, safety and efficacy.
We regulate these activities to protect public health and ensure human cell and tissue products remain safe and effective.
If you import or export human cell and tissue products, you must comply with Australian laws.
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.