Australia Clinical Trial Notification → The TGA’s Role in Drug Registration

There are several phases in the prescription medicines registration process that must be completed in order for the product to be approved. These phases are designed to evaluate the quality, safety and effectiveness of drugs based on data from clinical trials, ensuring they pose minimal risk to the Australian community. The TGA is responsible for overseeing the phases involved with registration, and at completion will reach a decision on whether to register the medication or reject it.

Experts such as scientists and health professionals are tasked with evaluating the safety and effectiveness of these goods. These experts investigate both the benefits and the risks involved with medications, including side effects, toxicities, long-term sequelae and the nature of the medical condition. If the TGA is satisfied that the benefits of the product outweigh associated risks, then the drug will be approved and registered.