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ACM meeting statements
Role of the Advisory Committee on Medicines in the TGA's regulatory decision making process
The ACM 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 ACM provides advice to the TGA on, amongst other things, the safety, quality and efficacy of registered medicines, including in relation to pharmacovigilance.
The advice provided by the ACM 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 neither a TGA delegate nor the TGA is obliged to seek this advice in making a decision or to follow it.
The ACM meeting statement aims to describe in general terms the matters considered by ACM at each meeting, having regard to any commercial-in-confidence information.
The ACM meeting statement is divided into two sections:
- Section A (Submissions for registration) refers to new pre-market items referred to ACM 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 ACM members and invited experts during its deliberations. Further details of the ACM discussions and advice associated with pre-market items are released within the Australian Public Assessment Reports (AusPars) for each new active. An AusPAR is generally prepared for products containing new chemical and biological entities, biosimilar medicines, major variations and extensions of indications once the evaluation period has been completed. Published AusPARs are available on the TGA website.
- Section B (Post-Market items referred for advice) of the ACM meeting statement refers to post-market items discussed at a particular ACM, and is often more detailed, as the information referred to, and relied on, by ACM does not usually contain commercial-in-confidence material.