The regulatory framework for biologicals initially provided the legislative basis for the regulation of human tissue and cell-derived products that are supplied, in or exported from, Australia.

The biologicals legislation commenced on 31 May 2011, following a recommendation from Australian Commonwealth, State and Territory Health Ministers to improve the regulation of human tissues and cell based therapies.

In 2017, live animal cell, tissues or organs were added to the biologicals framework.

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

All products within the scope of the framework need to comply with the requirements made under the new legislation. For currently supplied biologicals there is a three year transition period to meet the new requirements and to be included in the Australian Register of Therapeutic Goods (ARTG).

Legislation, standards and guidelines

The legislation is available from: Legislation & legislative instruments. The legislation that has been updated for the 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 2017 (No. 1)
• Therapeutic Goods (Manufacturing Principles) Determination No. 1 of 2013
• Therapeutic Goods (Manufacturing Principles) Amendment Determination 2017 (No.1)
• Therapeutic Goods (Excluded Goods) Order No. 1 of 2011
• Therapeutic Goods Orders (product standards for biologicals)

The Australian Regulatory Guidelines for Biologicals provides sponsors, manufacturers, and the general public with information and guidance about the regulation of biologicals.

Further information

There are various forms for the biologicals industry, including application forms for including a biological in the ARTG from TGA eBusiness Services.

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