The University of Melbourne’s Drug Evaluation Unit (DEU) is contracted by the Therapeutics and Good Administration (TGA), Australian Government, Department of Health as part of its External Evaluators panel. The DEU is based in the Clinical Pharmacology and Therapeutics Unit, Department of Medicine at Austin Health. The DEU has conducted over 350 evaluations over the past 25 + years. We review and provide recommendations to TGA regarding marketing authorization for New Chemical Entity (NCE) or extension/ modification of currently approved drugs. The complexity and volume of data reviewed also determines the funding received from the TGA.
The DEU has consistently received average funding of approximately $500,000 p.a for the past 25 years. The final evaluation report is a critical component of the decision making process and the Advisory Committee on Medicines (ACM) uses this evaluation report as the main source of information about the clinical aspects of the submission for marketing authorisation. A copy is sent to the Sponsor and may also be provided to overseas medicine regulatory agencies (FDA, EMEA, Canada Health, etc.). For all drugs that receive marketing authorisation, the evaluator’s reports are also used in the preparation of an AusPAR (Australian Public Assessment Reports for prescription medicines) that is published on the TGA web site. The DEU remains the only such dedicated unit in Australia which conducts critical scientific evaluations of large amounts of clinical trial data.
Besides building a highly regarded skill-base, knowledge framework and a collaborative network between the University of Melbourne and the Australian Government Department of Health, the DEU makes a significant contribution towards the process of providing safe and effective drug treatments in a timely manner for the community. |