The University of North Carolina at Chapel Hill
Skip to main content

Australia Clinical Trial Notification → TGA/ACM Approval

Overview
What is the TGA & ACM?

Any medicine sold in Australia must have received approval for registration by the Therapeutic Goods Administration (TGA). Once initial clinical trials have been completed, the TGA needs to consider a range of information and advice in deciding whether a medicine or medical device should reach the Australian public. A sanctioned body called the Advisory Committee on Medicines (ACM) assists the TGA in evaluating issues surrounding the safety, quality and effectiveness of medicines supplied in Australia. This information helps the TGA to make decisions about pre-market and post-market medications. After a decision has been made and the product has been approved, it will be listed on the Australian Register of Therapeutic Goods (ARTG).

Learning Objectives

  1. Understand the TGA’s role in prescription medication registration
  2. Identify and describe the 8 phases of prescription medication registration
  3. Explain the role of the ACM in the registration process
  4. Identify the components and understand the purpose of an AusPAR