Following public consultation by the TGA on the regulation of autologous human cell and tissue products in 2015 and 2016, the Government has decided to change the regulation of human cells and tissues for autologous use under the supervision of a medical or dental practitioner. As a result of the changes, a larger proportion of these products will become subject to regulation by the TGA, with the level of regulation being determined by the risk posed to patient safety.
On the 1st July 2018 new guidance from the TGA on autologous human cell and tissue (HCT) products started. In order for HCT products to be excluded from TGA regulation the Clinician must meet all of the following:
- collected from a patient who is under the clinical care of a medical or dental practitioner registered under a law of a State or an internal Territory
- manufactured by that medical or dental practitioner, or by a person or persons under the professional supervision of that medical or dental practitioner in a hospital, for that patient who must be a patient of that hospital
- for therapeutic use in that patient by the same medical or dental practitioner, or by a person or persons under the professional supervision of the same medical or dental practitioner
- not advertised or promoted directly to consumers.
All of the above criteria must be met for this exclusion to apply. Where one or more of the criteria are not met, including if advertising occurs directly to consumers, a higher level of regulatory requirements will apply.
Further details can be found on the TGA biologicals on the restrictions when outside of an accredited hospital.
The conditions for exclusion do not include any restrictions on:
- the level of manufacturing (including storage and processing beyond minimal manipulation)
- on the treatment that can be used by practitioners within the hospital.
Further information on the regulation of the ‘manufacture and use in a hospital‘ is provided in the definitions.
The following also applies to all autologous HCT products (both Exempt and Fully Regulated products):
- Reporting of adverse events to the TGA. Bioviligance reporting reporting requirements summary
- Compliance with all applicable standards
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.