TGA statutory advisory committees
Statutory advisory committees are established by the Therapeutic Goods Regulations 1990.
The TGA currently has eleven 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.
- Advisory Committee on Complementary Medicines (ACCM)
The ACCM advises and makes recommendations regarding the entry of complementary medicines on the ARTG
- Advisory Committee on Medicines Scheduling (ACMS)
The ACMS advises and makes recommendations about how medicines will be made available to the public
- Advisory Committee on Non-prescription Medicines (ACNM)
The ACNM advises and makes recommendations regarding the entry of non-prescription medicines on the ARTG
- Advisory Committee on Prescription Medicines (ACPM)
The ACPM advises and makes recommendations regarding the entry of prescription medicines on the ARTG
- Advisory Committee on the Safety of Medicines (ACSOM)
The ACSOM makes recommendations on the safety of medicines and risk assessment and risk management of medicines
- Advisory Committee on the Safety of Vaccines (ACSOV)
The ACSOV advises and makes recommendations on the safety, risk assessment and risk management of vaccines
Medical devices committees
- Advisory Committee on Medical Devices (ACMD)
The ACMD advises and makes recommendations regarding the entry of medical devices on the ARTG
- Advisory Committee on the Safety of Medical Devices (ACSMD)
The ACSMD advises and make recommendations on the safety, risk assessment, risk management and performance of medical devices supplied in Australia
- Advisory Committee on Biologicals (ACB)
The ACB advises and makes recommendations relation to cell and tissue therapy products ("biologicals")
- Advisory Committee on Chemicals Scheduling (ACCS)
The Advisory Committee on Chemicals Scheduling advises and makes recommendations regarding how chemicals will be made available to the public.
- 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 statutory advisory committees
If you are interested in becoming a member of a TGA statutory advisory 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 advisory committee forms
TGA statutory advisory committee forms
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.
- Fifty years of independent expert advice on prescription medicines
This booklet highlights a number of the significant achievements of the ADEC and its successor, the Advisory Committee on Prescription Medicines (ACPM), in facilitating and enabling access to new medicines and in preventing the introduction of medicines that are ineffective or have major safety problems