Over the coming months, new regulations will be drafted by the Office of Parliamentary Counsel and submitted to Government for approval.
The proposed changes to the regulation of autologous cell and tissue products are to:
- Not permit direct advertising to consumers of autologous cell and tissue products, similar to the prohibition in Australia in the advertising of prescription medicines, but noting that services (that do not mention specific products) will still be permitted to be advertised.
- Exclude from regulation by the TGA only those autologous cell and tissue products that are manufactured and used in a hospital by a medical or dental practitioner, for a patient in the care of the same practitioner.
- Introduce regulation by the TGA, with exemptions from some requirements, for autologous cell and tissue products that are:
- minimally manipulated, and
- for homologous use only, and
- manufactured and used outside a hospital by a medical or dental practitioner,
- for a patient in the same practitioner’s care.
- Regulate under the Biologicals Regulatory Framework those autologous human cell and tissue products that are:
- manufactured and used outside an accredited hospital, and
- more than minimally manipulated, or
- for non-homologous use.
Products would fall into the relevant class, based on risk. Inclusion in the Australian Register for Therapeutic Goods and Compliance with TGA standards is required, including manufacturing standards. Adverse event reporting to TGA is required and advertising of the products to the public would not be permitted. Link for more information.
Cytori Cell Therapy™ was approved for clinical use on June 24th, 2016 to treat knee osteoarthritis at the Tokyo Osteoarthritis Clinic under the Japanese ‘Act on the Safety of Regenerative Medicine’ that was enacted on November 25, 2014. Link for more information.
Australian Cell Therapy Society Presentations
Cosmotex 2016, Sydney: Thomas et al: The Autologous Cell Therapy Group and its Code of Conduct.