Document Reference: AHQ-WEB-EDU-Q4-001 | Version 1.0 | April 2026
| Important Notice: This is an educational resource. It does not constitute medical advice or a treatment recommendation. |
The regenerative medicine field in Australia includes providers operating across a wide spectrum — from fully TGA-compliant, hospital-based programs to unregistered clinics offering procedures that fall outside the regulatory framework entirely. For patients, navigating this landscape without the right questions is difficult.
These four questions cut through the noise. A provider operating within Australia’s regulatory framework should answer yes to all of them without hesitation.
1. Is the product TGA-regulated?
In Australia, cellular therapies are regulated by the Therapeutic Goods Administration as biologicals. A compliant provider will either hold TGA registration for their product, or operate under the TGA’s same surgical procedure (SSP) exemption — which permits autologous cells to be harvested and returned to the same patient within a single hospital procedure. Ask the provider which pathway applies and request documentation if needed.
2. Is the procedure delivered in an accredited hospital?
The TGA SSP framework requires procedures to be performed within a TGA-licensed facility. For autologous SVF therapy, this means an accredited day hospital or surgical facility — not a GP clinic, wellness centre, or cosmetic surgery suite. Ask specifically which hospital is used and whether it holds the appropriate accreditation.
3. Is a qualified specialist involved?
Clinical suitability for cellular therapy must be assessed by a qualified medical specialist, not determined by a website questionnaire or a GP consultation alone. Ask who will perform your specialist assessment, what their specialty is, and whether they are registered with AHPRA.
4. Is there a documented clinical governance framework?
Clinical governance refers to the systems a provider has in place to ensure consistent standards of care, adverse event reporting, patient follow-up, and communication with referring practitioners. Ask whether the provider has a documented clinical governance framework and whether your GP will receive written communication following your procedure.
Aeterna Health Queensland answers yes to all four questions. All procedures are delivered at Southport Day Hospital under specialist oversight, within the TGA SSP framework, with written communication to referring GPs at each clinical stage.
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