The TGA introduced the Biologicals Regulatory Framework in 31 May 2011. This new regulatory guidance had a three year transition which finished in May 2014. There is some confusion with regard to the terminology – ‘biologicals’ by the TGA definition include human tissue and cell therapies which are termed Advanced Therapies in other jurisdictions (such as US and EU).

The Biologicals Regulatory Framework in Australia covers a range of human tissues therapies (including skin, musculoskeletal, ocular and cardiovascular) and cell therapies. The cell therapies include cells which have been genetically modified or subject to in vitro cell expansion/depletion. For the purpose of regulation, these therapies are classified into four groups dependent on the perceived risk of the product. For examples, therapies which have nil or minimal manipulation are considered to have less inherent risk than those therapies which have been the subject of greater manipulation (including genetic modification). Likewise, products which closely match their original biological function are considered to pose less risk than those which are utilized for a different purpose i.e. dermal fibroblasts for skeletal muscle repair in primary myopathy (e.g. Duchenne muscular dystrophy).

There are also a range of products which are regulated by the TGA as therapeutics not as biologicals including: blood products, recombinant proteins, monoclonal antibodies, products of assisted reproduction, in vitro diagnostics (IVD), fresh viable organs, haematopoietic progenitor cells and autologous cells and tissues for a single patient under care of a single medical practitioner.