A new regulatory framework for biologicals was passed on 10 March 2011 which will amend the Therapeutic Goods Regulations 1990. This new framework will commence on 31 May 2011 and new biological products must comply with the new requirements before they can be legally imported, exported, supplied or used.
The biologicals framework will regulate cell-based products (genetically modified, in vitro cell expansion/depletion), human cellular vaccines, human tissuebased products (skin, musculoskeletal, cardiovascular, ocular), and human stem cells (including mesenchymal stem cells and haematopoietic progenitor cells for non-haematopoietic use) in addition to therapeutic goods that meet the definition of a biological under the new guidelines. However, the new framework excludes certain biological medicines (such as vaccines, peptides, monoclonal antibodies and other recombinant products), haematopoietic progenitor cells used for haematopoietic reconstitution, in vitro diagnostics containing human cells or tissues, labile blood and blood components, human cells or tissue taken as samples for diagnostic use, unmanipulated reproductive tissue, and tissue or cell therapy products of animal origin. These types of therapeutic goods will be subject to separate regulatory requirements.
A new classification scheme for biologicals based on the level of risk will be implemented which is similar to the scheme for medical devices. Biologicals supplied before 31 May 2011 will continue to be regulated under the “old” regime until the TGA transfers them to the biologicals part of the ARTG. The legislation provides transitional measures and all currently supplied biologicals will have three years to meet the new requirements. The TGA is currently developing guidance documents for the new framework.