Australia’s Therapeutic Goods Administration (TGA) on Friday released proposed changes to its biologics regulatory framework, to take effect on 1 July 2018, that would regulate certain treatments that were previously excluded from the regulations.
In general, the proposal, which echoes similar regulations in the US, says that if a product “is subject to processing that is more than minimal manipulation, the definition of a blood component does not apply and such a product would be regulated as a biological.”
Among such products that have been previously excluded from regulation but are now likely to be regulated as biologicals or blood and blood components are adipose-derived cell extract (including stromal vascular fraction) and conditioned serum.
Leigh Turner, associate professor at the Center for Bioethics, School of Public Health, & College of Pharmacy at the University of Minnesota, explained to Focus
: "The new regulations in many respects resemble the regulatory framework articulated by the U.S. FDA in its recent final guidance documents concerning cells and tissues. Perhaps the most striking commonality is that both Australia’s TGA and the US FDA have classified autologous adipose-derived stem cell interventions as fully regulated biologicals requiring premarketing authorization."
He also noted that Australia, like the US, has a large marketplace of clinics engaged in direct-to-consumer advertising of unproven and unapproved "stem cell treatments." Patient advocates and researchers
have expressed concern that many clinics in Australia are persuading clients to undergo stem cell procedures by making misleading advertising claims, he said.
“There are a wide range of methods used to collect and process adipose tissues to isolate cells prior to re-injection in the patient. We would consider almost all of them to fall outside of the eligibility criteria for exclusion or the exemptions from regulation,” the guidance says on adipose-derived cell extract. “The methods used to prepare adipose-derived cell extracts are generally considered to be more than minimal manipulation.”
And for autologous conditioned serum, “where the serum is cultured for several hours to induce the white blood cells to secrete anti-inflammatory compounds into the serum … The processing of the blood component, in this case, is considered more than minimal manipulation; and thus conditioned serum products will be fully regulated as a biological.”
Examples of products likely to be excluded from regulation, but under certain eligibility criteria, include skin grafts (including keratinocyte sprays), craniotomy and parathyroidectomy, vascular conduits, pancreatic islet cells, bone grafts, bone marrow transplants, autologous blood to seal cerebrospinal fluid leaks and blood autologous components.
Turner also notes that an aspect of the proposed biologicals regulatory framework resembles regulation of stem cell products by the European Medicines Agency in that the regulatory exclusions address the use in hospitals of autologous human cells and tissue products
“Autologous platelet-rich plasma is not likely to meet the criteria for exclusion, unless collected and manufactured in a hospital,” the guidance adds.
The guidance also discusses the timelines for when the proposal, which TGA says has not yet become law and may be subject to change, may take effect.
Biologicals regulatory framework proposed changes to start on 1 July 2018