In 2018, Australia's Therapeutic Goods Administration introduced regulatory reforms that set stricter criteria around the regulation of products derived from a patient's own cells and tissues, posing significant implications for clinics offering stem cell treatments. We review the regulatory framework and discuss its potential commercial implications, including the ambiguities that may arise from it in practice, as well as the likely impact it will have on product development and advertising practices in the future.
- autologous stem cell-based interventions
- commercial stem cell clinics
- human cell and tissue products
- legal regulation
- regulation of biologicals
- regulatory framework