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
For more information and to apply, please visit TGA committee vacancies.
Conflicts of interest and confidentiality obligations
The TGA has strong protections and processes to manage conflicts of interest (also called material personal interests) in relation to matters coming before statutory advisory committees.
Australia is a small jurisdiction, so persons with the necessary expertise to contribute to committees may also have work, professional, financial or other interests (including in relation to immediate family or close friends) that can present a real or perceived conflict of interest.
Potential conflicts of interest are considered as part of the appointment process. Individuals with existing interests that would prevent, or substantially limit, them from performing the duties of a committee member effectively will not be considered.
In addition, the Minister may terminate a member’s appointment for failure to comply with disclosure of interest provisions in the Therapeutic Goods Regulations 1990.
Committee members are required to disclose their interests at multiple points. These include:
- when applying to become a member
- when applying to become a member
- on appointment
- as part of an annual declaration process
- before or at each committee meeting
- at any other time during the period of membership if a member becomes aware of additional interests or changes to interests.
During a committee meeting, unless the committee determines otherwise, a member who has disclosed a material personal interest in relation to an agenda item will be excluded from participating in that agenda item.
The following guidance is to assist members, chairs and secretaries of TGA statutory advisory committees (and their subcommittees and working groups) about:
- declaration of interest requirements
- the general process for managing conflicts of interest, and
- confidentiality obligations.
Further specific guidance is provided for committee members on the management of conflicts of interest at committee meetings:
2017 Changes to Advisory Committees
Information on TGA Committees prior to January 2017 is available in Trove.