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Statutory expert committees

Statutory advisory committees are established by the Therapeutic Goods Regulations 1990.

The TGA currently has nine 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. Further information on each committee is available at the links provided below.

The advice provided by these committees is an important element in the undertaking by the TGA of its regulatory functions. However, it will form only part of the information that is available to, for instance, a TGA delegate making a regulatory decision under the Therapeutic Goods Act. While appropriate consideration will be given to such advice, it is important to note that neither the TGA nor a TGA delegate is obliged to follow it.

It should also be noted that information about advice provided by a committee may not become publicly available until sometime after a committee has provided that advice, for instance through the publication of an AusPAR about a newly registered prescription medicine. However, from 2013 a statement that broadly canvasses the matters considered by the committees at each meeting will be made publicly available within a short period after the meeting.

Committee members are appointed by the Minister and must have expertise in relevant clinical or scientific fields or appropriate consumer issues.

Current committees

• Advisory Committee on Biologicals (ACB)
  The Advisory Committee on Biologicals (ACB) advises and makes recommendations to the TGA in relation to cell and tissue therapy products ("biologicals").
• Advisory Committee on Complementary Medicines (ACCM)
  The Advisory Committee on Complementary Medicines (ACCM) advises and makes recommendations to the TGA regarding the entry of complementary medicines on the Australian Register of Therapeutic Goods.
• Advisory Committee on Medical Devices (ACMD)
  The Advisory Committee on Medical Devices (ACMD) advises and makes recommendations to the TGA regarding the entry of medical devices on the Australian Register of Therapeutic Goods.
• Advisory Committee on Non-prescription Medicines (ACNM)
  The Advisory Committee on Non-prescription Medicines (ACNM) advises and makes recommendations to the TGA regarding the entry of non-prescription medicines on the Australian Register of Therapeutic Goods.
• Advisory Committee on Prescription Medicines (ACPM)
  The Advisory Committee on Prescription Medicines (ACPM) advises and makes recommendations to the TGA regarding the entry of prescription medicines on the Australian Register of Therapeutic Goods.
• Advisory Committee on the Safety of Medical Devices (ACSMD)
  The Advisory Committee on the Safety of Medical Devices (ACSMD) advises and make recommendations to the Minister for Health and the Therapeutic Goods Administration (TGA) on the safety, risk assessment, risk management and performance of medical devices supplied in Australia.
• Advisory Committee on the Safety of Medicines (ACSOM)
  The Advisory Committee on the Safety of Medicines (ACSOM) was formed in January 2010 to advise and make recommendations to the TGA on the safety of medicines and risk assessment and risk management of medicines.
• Advisory Committee on the Safety of Vaccines (ACSOV)
  The Advisory Committee on the Safety of Vaccines (ACSOV) advises and makes recommendations to the Minister for Health and the Therapeutic Goods Administration (TGA) on the safety, risk assessment and risk management of vaccines.
• Therapeutic Goods Committee (TGC)
  The TGC advises the Minister on standards for therapeutic goods, including labelling and packaging, and on principles to be observed in the manufacture of therapeutic goods for use in humans.

Appointments to expert statutory committees

If you are interested in becoming a member of TGA expert statutory committee please see the following information.

• TGA advisory committee guidelines
  The purpose of these guidelines is to provide guidance for members, chairs and secretaries of the TGA's statutory expert advisory committees (and their sub-committees)
• Statutory expert committee vacancies
  Expressions of interest for statutory advisory committee vacancies.
• Statutory expert committee forms
  TGA statutory advisory committee forms

Committees history

In January 2010 an amendment to the Therapeutic Goods Regulations resulted in changes to the names, membership and operation of advisory committees. These changes are contained in Therapeutic Goods Amendment Regulations 2009 No.6.

Information on TGA Committees prior to January 2010 is available in the TGA Internet site archive.