Australia Clinical Trial Notification → Expert Advisory Review & Decision (Phase 6-8) – ACM, AusPAR, ARTG

Phase 6: Expert advisory review

The TGA often requests additional advice when appraising a medicine, especially if it is a new product or has a new indication. In these situations, referral to the Advisory Committee on Medicines (ACM) is warranted.

The ACM, created in 2017, comprises experts in science or medicine who provide independent advice to the TGA. The TGA must first send a “Request for ACM” letter to both the applicant and the ACM. This letter contains an overview of the application, any specific concerns the TGA would like advice on, and whether any special registration conditions are needed.

The applicant can view this letter and compile a “Pre-ACM response” that addresses any issues found by the TGA. Issues may include concerns about missing data or false claims made by the applicant. This response must be received before the ACM meeting.

At the ACM meeting, the committee will review the Request for ACM letter and the Pre-ACM response, as well as all other information received from the applicant thus far. The committee will discuss issues surrounding the submission to reach a conclusion. It is important to note that the ACM only provides advice to the TGA, and cannot make decisions about the registration of the medication. The TGA may decide to agree with the ACM and follow their advice, or it may choose to ignore any information it provides and go against its recommendations.

Phase 7: Decision

The TGA reviews the ACM’s advice and makes a decision about the application. This decision is made known to the applicant through a letter. If the application is rejected, the applicant is told why. Approval may be conditional until issues are resolved.

If the application is approved, the applicant will have time to make changes and resolve any outstanding issues relating to the Product Information and Consumer Information.

Phase 8: Post-decision

If the product has been approved, it will be listed on the Australian Register of Therapeutic Goods (ARTG). This means that the drug is now registered.

Information about the product as well as the decision-making process will be published by the TGA on their website after registration. This information includes:

• An Australian public assessment report (AusPAR)
  An AusPAR contains details of what was considered and discussed at ACM meetings, as well as the advice they provided to the TGA that lead them to approve or reject an application. It also includes background information on the product, a registration timeline, submission overview, risk/benefit assessment and Product Information.
  This document is created during Phase 8. Once published, this document does not undergo further changes. Therefore, the Product Information listed in the AusPAR may be outdated if further updates have been made since publication. If there are significant changes made to the medicine, a new AusPAR will be developed.
• Product Information (PI)
  This document contains in depth information about the drug, and helps health professionals evaluate whether the drug is safe and appropriate for their patients.
• Consumer Medicines Information (CMI)
  This document is designed for patients who want to find out more information about the medication.

The registration process is now complete. This process can take up to 12 months depending on the product. The drug is now available to use by the Australian public.