The Therapeutic Goods Administration (TGA), a division of the Australian Government Department of Health, is in charge of regulating the process for the development and drug approval process in Australia. Prior to the sale of medicines in Australia, pharmaceuticals and other therapeutic items must first be approved by the TGA for their safety, quality, and efficacy. The typical approval process for this drug takes 240-260 working days.
Drug development and drug approval process in Australia consists of many stages:
1. Discovery and Preclinical Development: Identifying prospective drug candidates and conducting laboratory and animal research to determine their safety and effectiveness are part of this step.
2. Clinical Trials: Once a prospective drug candidate has been found and proved to be safe and effective in animal tests, clinical trials to test the drug in people are done. Clinical trial approval process in Australia are often divided into three stages:
· Phase 1: The medicine is administered to a small number of healthy volunteers to determine its safety and ideal dosage.
· Phase 2: The medicine is administered to a larger number of patients in order to determine its efficacy and safety.
· Phase 3: A large-scale, randomized, controlled trial is done in phase 3 to establish the drug’s efficacy and safety in a bigger population.
3. The applicant sends a pre-submission planning form (PPF) to TGA (2-6) months before submission during the initial Pre-submission phase (50 working days). TGA records PPF and starts processing on the first day of each month, after which it sends to the applicant a planning letter outlining submission milestones, any comments, and particular conditions.
4. During the phase of submission (20 working days), the applicant must submit an official submission dossier as well as payment for 75% of the evaluation fees by the 15th of the month. TGA processes submissions and assesses whether they comply with the Australian Regulatory Guidelines for Prescription Medicines (ARGPM) and are eligible for consideration. TGA sends applicant a letter informing them of their decision.
5. TGA assesses the primary and secondary assessment units in the initial phase of assessment (80 working days) and summarizes inquiries and problems into a consolidated answer for the applicant. Applicants must respond within the combined s.31 response period (20–40 working days). The 30-day or 60-day response period is specified in the PPF. The applicant prepares and submits a response to the TGA. As the applicant’s s. 31 responses conclude, and if no further response is received, the examination continues.
6. TGA examination of response and final evaluation report is undertaken in the second round of the assessment phase (20 working days). The applicants have time to study the report and make necessary adjustments. It is followed by the Expert advisory review phase (5-10 working days), in which the TGA delegate requests advice from the Advisory Committee on Prescription Medicines (ACPM), which in turn requests advice from the Pharmaceutical subcommittee (PCS) and, optionally, the Advisory Committee on the Safety of Medicines (ACSOM). The TGA then distributes ACPM advising sheets and sends prepared advice to the applicant.
7. The TGA delegate assesses and decides throughout the decision phase (10 working days). The decision letter once prepared, the remaining 25% fees will be charged to the applicant.
8. If the application is rejected, the applicant has 90 days to file an appeal.
9. The Australian public assessment report (AusPAR) by TGA is published in the post-decision phase (40 working days).
10. Redaction of applicant AusPAR C-I-C documents is published on the TGA website, followed by registration on the Australian Register of Therapeutic Goods (ARTG).
Overall, Australian drug regulatory system is streamlined and is time bound to ensure the availability of quality medicines to the citizen.
