Guide to Accessing Medicines in Australia

This guide outlines the process of accessing new medicines in Australia, detailing the steps from discovery to patient availability. It begins with pre-clinical research, where pharmaceutical companies develop new molecules over an average of four years. Following this, promising molecules undergo clinical trials, which can take up to nine years, and are subject to rigorous evaluation for safety and efficacy. The guide explains the role of the Therapeutic Goods Administration (TGA) in regulating the approval of medicines, as well as the Pharmaceutical Benefits Scheme (PBS) that subsidizes the cost of most prescription medicines. The process includes recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), which assesses the cost-effectiveness of new medicines. Additionally, the guide describes the phases of clinical trials, the involvement of various organizations, and the application process for getting a new medicine listed on the PBS. It also addresses how patients can participate in clinical trials and access medicines prior to their official approval.