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ACV meeting statements
Advisory Committee on Vaccines
Role of the Advisory Committee on Vaccines in the TGA's regulatory decision making process
The Advisory Committee on Vaccines (ACV) 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 ACV provides advice to the TGA on, amongst other things, the safety, quality and efficacy of vaccines, including in relation to pharmacovigilance, and on the safe use of vaccines in the national immunisation programs.
The advice provided by the ACV is an important element in the undertaking of 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, it is important to note that a delegate is not obliged to seek or follow advice from the committee.
The ACV meeting statement aims to describe in general terms the matters considered by ACV at each meeting, having regard to any commercial-in-confidence information.
The ACV meeting statement is divided into three sections:
- Section A (Submissions for registration) refers to new pre-market items referred to ACV for advice. The detail contained within this section is limited due to the commercial-in-confidence information that is often referred to, and relied on, by the ACV members and invited experts during the committee's deliberations. Further details of the ACV discussions and advice associated with pre-market items are released within the Australian Public Assessment Reports (AusPARs). An AusPAR is generally prepared for new vaccines and extensions of indications once the evaluation period has been completed. Published AusPARs are available on the TGA website.
- Section B (Pharmacovigilance) describes the post-market items discussed at an ACV meeting. This section is often more detailed than Section A, as the information referred to, and relied on, by ACV does not usually contain commercial-in-confidence materials.
- Section C (Immunisation programs) summarises advice provided to the Department of Health in relation to assessments before a vaccine is put on the market and monitoring once a vaccine is on the market, including as part of the National Immunisation Program.