Regulatory framework for biologicals
The regulatory framework for biologicals provides the legislative basis for the regulation of human tissue and cell-derived products that are supplied, in or exported from, Australia. Live animal cell, tissues or organs were added to the biologicals framework in 2017.
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. The framework has also been designed to be flexible enough to accommodate emerging technologies.
Following consultation, we are proposing changes to the Biologicals Regulatory Framework, which will start on 1 July 2018:
- Biologicals Regulatory Framework proposed changes to start on 1 July 2018
including changes to regulation of autologous human cell and tissue products, some definitions and the classification rules for biologicals.
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 2017 (No. 1)
- Therapeutic Goods (Manufacturing Principles) Determination No. 1 of 2013
- Therapeutic Goods (Excluded Goods) Order No. 1 of 2011
Biologicals must conform to relevant standards:
- The Australian Regulatory Guidelines for Biologicals provide sponsors with guidance about the regulation of biologicals.
- Manufacturing biologicals provides manufacturers with guidance about manufacturing biologicals
If you have any further queries or would like further information please contact the TGA.