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TGA statutory advisory committees
The TGA's statutory advisory committees are established under Part 6 of the Therapeutic Goods Regulations 1990 (the Regulations).
There are currently seven statutory advisory committees that provide independent expert advice on specific scientific and technical matters. The majority of committee members are appointed by the Minister (some specific members are determined by the relevant State and Territory jurisdictions) and must have expertise in relevant clinical or scientific fields or appropriate consumer health issues.
The advice provided by these committees is an important element in the regulatory functions of the TGA and while a TGA delegate considers this information when making a regulatory decision under the Therapeutic Goods Act 1989, they are not obliged to follow it.
Information about advice provided by a committee may not become publicly available immediately following a meeting. For example, it may not become available until the publication of an Australian Public Assessment Report for prescription medicines (AusPAR). General details of matters considered by the committees at each meeting will be made publicly available shortly after the meeting.
Further information on each committee is available at the links below.
Current advisory committees
- 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 ACCS advises and makes recommendations regarding how chemicals will be made available to the public
- Advisory Committee on Complementary Medicines (ACCM)
The ACCM advises and makes recommendations regarding the entry of complementary medicines on the ARTG
- Advisory Committee on Medical Devices (ACMD)
The ACMD advises and makes recommendations regarding the safety and performance of medical devices
- Advisory Committee on Medicines (ACM)
The ACM advises and makes recommendations regarding the entry of 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 Vaccines (ACV)
The ACV advises and makes recommendations on vaccines, including safety, quality and efficacy
Conflicts of interest and confidentiality obligations
This guidance is to assist members, chairs and secretaries of TGA statutory advisory committees (and their subcommittees and working groups), established under Part 6 of the Therapeutic Goods Regulations 1990 (Regulations), about their:
- declaration of interest requirements
- management of conflicts of interest related to matters coming before the committee
- confidentiality obligations
2017 Changes to Advisory Committees
As part of the response to the Expert Review of Medicines and Medical Devices Regulation (the MMDR), the Government agreed to a more streamlined structure for TGA's advisory committees. The number of committees was reduced from 11 to 7. The necessary changes to TGA's regulations to achieve this new structure are contained in the Therapeutic Goods Amendment (Advisory Committees and Other Measures) Regulation 2016 and came into effect on 1 January 2017.
A summary of the changes included:
- introduction of the broader Advisory Committee on Medicines (ACM), which covers the roles of the former: Advisory Committee on Prescription Medicines (ACPM), the Advisory Committee on Non-prescription Medicines (ACNM) and the Advisory Committee on the Safety of Medicines (ACSOM)
- introduction of the broader Advisory Committee on Vaccines (ACV), which replaced the Advisory Committee on the Safety of Vaccines and includes some of the functions relating to vaccines of the former ACPM
- the Therapeutic Goods Committee (TGC) was abolished, but its core role of advising and making recommendations about standards for therapeutic goods is preserved across the relevant new or continuing committees
- the Advisory Committee on Medical Devices (ACMD) continued and also now covers the role of the former Advisory Committee on the Safety of Medical Devices (ACSMD)
- two committees, the Advisory Committee on Biologicals (ACB) and the Advisory Committee on Complementary Medicines (ACCM) continued with expanded functions
- two committees, the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS) continued unchanged
Information on TGA Committees prior to January 2017 is available in the TGA Internet site archive.