Role of the ACB in the TGA's regulatory decision making process
The Advisory Committee on Biologicals (ACB) is a statutory advisory committee established by the Therapeutic Goods Regulations 1990.
The TGA currently has seven statutory advisory committees from which it can obtain independent expert advice on specific scientific and technical matters to aid the TGA's regulatory decision-making and other regulatory processes. The ACB provides advice to the TGA on, amongst other things, matters relating to the inclusion, variation, removal or continued inclusion of biologicals (cell and tissue therapy products) on the Australian Register of Therapeutic Goods.
The advice provided by the ACB is an important contribution to the regulatory functions of the TGA. However, it forms only part of the information that is available to a TGA delegate making a regulatory decision under the Therapeutic Goods Act 1989. While appropriate consideration will be given to such advice, neither the TGA nor a TGA delegate is obliged to follow it.
Information about advice provided by the committee may not become publicly available for some time after a committee has provided that advice. The purpose of this Meeting Statement is to describe in general terms the matters considered by the committee at each meeting.
Overview of therapeutic goods referred for advice
At this meeting, the committee's advice was sought on on three issues:
- A proposed risk tolerability framework for infectious diseases.
- A request to vary the testing of blood donations.
- The regulation of autologous stem cell treatments.
The committee's advice on these issues was provided for consideration as part of the TGA's regulatory processes.
Further information
Meeting statements are made publicly available after each meeting.
For further information on the ACB, please visit the ACB web page or contact the ACB Secretary on 02 6232 8291 or email: acb@tga.gov.au