With more than 15 cellular therapy companies focussed on product development and infrastructure support and in excess of 25 current clinical trials, Australia is demonstrating an emerging strength with an active regenerative medicine eco-system with internationally-recognised basic and translational research.
The Australian regenerative medicine sector spans the whole field from tissue engineering through to stem cell therapy to gene and immuno-therapies.
AusBiotech’s Regenerative Medicine Advisory Group (RMAG), chaired by Silvio Tiziani, has launched a six-page publication recently with facts and figures that provide an overview of the new sector (academia, industry and regulatory ecosystem) as well as the benefits of partnering with Australia.
Titled Cellular Therapies and Regenerative Medicine in Australia, the booklet notes key industry milestones and activities.
Also launched recently was the 3rd edition of the NSW Stem Cell Network Snapshot, which provides profiles of stem cell companies in Australia.
Meanwhile, regulation impacting the emerging sector is evolving in Australia with the Government deciding that changes should be implemented for the regulation of autologous cell and tissue products.
The changes will see some of these products subject to regulation as biologicals, with the level of regulation being determined by the potential risk posed to patient safety.
The announcement notes that “autologous human cell and tissue products are those that are removed from and applied to the same person, so the donor and the recipient are the same. These include some products referred to commonly as ’stem cell treatments’.”
These products have previously been outside the TGA’s regulatory oversight because they were seen as an extension of medical practice, but the new provisions are in response to concerns of risk to patient safety due to the increasing complexity of options.
It is anticipated that changes to the regulation of autologous cell and tissue products will commence in early 2018, and a transition period will allow time to align with the new requirements. Detailed guidance on the new regulatory approach is currently being drafted.
More information can be found online.