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The purpose of the audit was to examine the efficiency, effectiveness and accountability of the Therapeutic Goods Administration's performance in evaluating and approving prescription drugs for public use. In particular the audit focused on analysing elements of the regulatory process associated with the evaluation of prescription drugs. In this context the audit reviewed the administrative operations performed within the Department's Drug Safety and Evaluation Branch, the Australian Drug Evaluation Committee and the Business and Services Branch of the TGA, rather than any processes preceding or succeeding those activities.
The objectives of the audit were to assist the Department in the timely identification of any deficiencies in the evaluation of responses from suppliers and options for addressing the deficiencies. The objectives were to:
test the Department's adherence to Commonwealth Procurement Guidelines for open and effective competition and to legislative and other Government specified requirements; and
provide a report to the Parliament, the Government and other interested parties on the probity of the evaluation process.
The scope of the audit was restricted to considering the processes employed by the Department in the selection of hearing devices for use under the voucher scheme.