15 April 2011. The amendments to the Therapeutic Goods Regulations 1990, to create a new regulatory framework for biologicals were passed by Executive Council on 10 March 2011. The biologicals framework will commence on 31 May 2011.
After this date, all products within the scope of the framework will need to comply with the requirements made under the new legislation, subject to relevant transition arrangements.
To assist stakeholders to prepare for the new framework, the TGA is developing the Australian Regulatory Guidelines for Biologicals and a communication strategy. To ensure the TGA has a good understanding of our stakeholders' information needs, we are establishing a Communications Reference Group that will include relevant industry and consumer representative bodies.
Information, including the public consultation documents and accompanying Resource Guide: Overview of the Biologicals Framework are available from: http://www.tga.gov.au/bt/hct.htm