https://www.tga.gov.au/sites/default/files/consultation-regulation-autologous-cell-and-tissue-products.pdf

Regulation of Autologous Stem Cells is no doubt a complex issue and calls for some major regulatory reforms. Whether the required regulatory reforms should involve TGA as the primary regulatory body or AHPRA, or a shared responsibility between various regulatory bodies depending on the type and extent of procedure, is yet another topic that calls for discussion.
Regarding the TGA consultation on regulation of autologous cell and tissue products and proposed consequential changes to the classification of biologicals (version 3.0, August 2016), option 3 seems to be the most viable one. This option allows the usage of human cells and tissue products without TGA oversight if it is done under supervision of a medical/dental practitioner, as part of a single course treatment, is not directly advertised to consumers and is not more than minimally manipulated. It allows for a different route to be taken if more than minimal manipulation occurs, and if the human and tissue products do not meet the exclusion criteria, they will be regulated by the TGA as any other biological in applicable class.

Regulations imposed should not hinder the patient from receiving timely treatment. Option 3 would allow healthcare/dental practitioners more flexibility with manipulation while also following certain requirements so as to ensure proper regulatory checks. This is the primary reason that I think this option is the most viable one among the 4 given options.

Also, in my opinion, the concept of “single course of treatment” can be retained but guidelines should be in place to define what it includes/excludes.

Reference:
Anon, (2016). [online] Available at: https://www.tga.gov.au/sites/default/files/consultation-regulation-autologous-cell-and-tissue-products.pdf %5BAccessed 21 Oct. 2016].

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