Australian regulation of autologous human cell and tissue products: implications for commercial stem cell clinics
Narcyz Ghinea, Megan Munsie, Christopher Rudge, Cameron Stewart
Regenerative Medicine | FUTURE MEDICINE LTD | Published : 2020
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.
Awarded by Australian Research Council
This work was supported by an Australian Research Council Linkage Project grant (LP150100739). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.