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:

• What is regulated as a biological

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

• Pathways for supply of biologicals
• Autologous human cells and tissues products regulation
• Faecal Microbiota Transplant (FMT) products regulation

Legislation

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

• Therapeutic Goods Act 1989
• Therapeutic Goods Regulations 1990
• Therapeutic Goods (Charges) Regulations 1990
• Therapeutic Goods (Things that are not biologicals) Determination No. 1 of 2011
• Therapeutic Goods (Things that are Biologicals) Specification 2019
• Therapeutic Goods (Manufacturing Principles) Determination 2018
• Therapeutic Goods (Excluded Goods) Determination 2018

Standards

Biologicals must conform to relevant standards:

• Biological standards

Guidance

• The Australian Regulatory Guidelines for Biologicals provide sponsors with guidance about the regulation of biologicals.
• Manufacturing biologicals provides manufacturers with guidance about manufacturing biologicals

Contact information

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