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Regulatory framework for biologicals

17 August 2020

The regulatory framework for biologicals provides the legislative basis for the regulation of human tissue and cell-derived products and live animal cell, tissues or organs that are supplied, in or exported from, Australia.

The biologicals legislation commenced on 31 May 2011, following a recommendation from Commonwealth, State and Territory health ministers to improve the regulation of human tissues and cell-based therapies. All products within the scope of the framework need to comply with the requirements made under the legislation.

The framework applies different levels of regulation to products based on the risks associated with their use. It is designed to be flexible enough to accommodate emerging technologies.

To help you understand whether your biological falls under the legal requirements of the regulatory framework for biologicals, refer to:

To help you understand how we apply the legislative requirements to biologicals, refer to:


The legislation is available from: Legislation & legislative instruments. Regulation of biologicals is specified in:


Biologicals must conform to relevant standards:


Contact information

If you have any queries or would like further information please contact us.