The objective of the audit was to assess the effectiveness of the department’s management of non-compliance with the Therapeutic Goods Act 1989 for unapproved therapeutic goods.

The objective of this audit is to examine the effectiveness of the TGA’s administration of complementary medicines regulation in Australia. The primary focus is on listed complementary medicines, which comprise about 98 per cent of these medicines.

The Therapeutic Goods Administration (TGA), a division of the Commonwealth Department of Health and Ageing, is responsible for the regulation of the manufacture and supply of therapeutic goods. The objective of the audit was to assess the TGA's regulation of non-prescription medicinal products. In particular, it reviewed the TGA's systems, procedures and resource management processes used to approve new manufacturers, monitor ongoing manufacturer and product compliance with mandated requirements, and manage non-compliance. The audit made 26 recommendations designed to improve the transparency, quality and reliability of regulatory decisions taken by the TGA and improve its accountability mechanisms by enhancing its management information systems.

The follow-up audit, Drug Evaluation by the Therapeutic Goods Administration [TGA], reviewed the extent to which TGA had implemented recommendations made by the ANAO in 1996 on the efficiency, effectiveness and accountability of TGA's evaluation and approval of prescription drugs for public use. This follow-up audit was conducted because of the importance of effective drug evaluation processes to public health.

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 audit focussed on the systems and processes OGTR has established for both receiving and assessing applications under the Act, and also for ensuring compliance with the statutory requirements through monitoring and inspection. The audit objective was to form an opinion on the discharge by OGTR of selected functions entrusted to it under the Act. The audit assessed the practices of OGTR against the following principal criteria: Assessment of applications under the Act: Whether OGTR has established systems and procedures for the management and assessment of applications under the Act. Ensuring compliance—monitoring, inspection and enforcement activities: Whether OGTR has established systems and procedures for ensuring compliance with the requirements of the Act. Performance management: Whether OGTR manages selected aspects of its work efficiently and effectively. The audit did not seek to form an opinion on the appropriateness of the chosen structure of the regime for regulating gene technology or the merit of the scientific judgments involved. The audit methodology included discussions with representatives from agencies that co-ordinate aspects of the co-operative regulatory regime for gene technology across Australian jurisdictions, with various other stakeholders and users of the regime, as well as with officers of OGTR, along with examination of OGTR documents and files.

The audit objective was to assess the effectiveness of the Therapeutic Goods Administration’s (TGA) application of the Code of Good Manufacturing Practice (Code of GMP) for prescription medicines.

The objective of this audit was to assess whether selected regulatory entities effectively apply the cost recovery principles of the Australian Government’s cost recovery framework. The selected regulatory entities were the Department of Agriculture and Water Resources, the Australian Maritime Safety Authority, and the Department of Health (Therapeutic Goods Administration).

The objective of the audit was to assess whether the APVMA is performing its key regulatory functions effectively. In particular, the audit examined the APVMA's arrangements for:

• planning and overseeing the delivery of regulatory functions;
• registering pesticides and veterinary medicines in a timely manner;
• obtaining external scientific advice to support the registration function;
• monitoring the quality of pesticides and veterinary medicines approved for sale in Australia; and
• administering its cost recovery framework.

The audit is a follow-up to Audit Report 12, 1995-96 Risk Management by Commonwealth Consumer Product Safety Regulators. The objectives of this follow-up audit were to determine the extent to which ANZFA had implemented the agreed recommendations contained in the 1995 Audit Report, and to determine the effectiveness of the implemented recommendations in improving food safety regulation.

The audit reviewed the Commonwealth management and regulation of plasma fractionation. The audit objectives were to:

• assess the administrative and financial effectiveness of the Department of Health and Aged Care's contract management of the PFA;
• assess whether the TGA's implementation of post sale regulatory arrangements adequately protects the community's interests; and
• assess the extent to which agencies have implemented the recommendations made in Audit Report No.14 1995-96 concerning funding of plasma products and regulation of plasma products manufactured under the PFA.

The objective of the audit was to examine how effectively Health manages the risk of PBS drugs not being used according to PBS subsidy conditions. The audit examined two areas: during listing, how Health identified and implemented measures to decrease the risks of PBS drugs being used outside subsidy conditions; and following listing, how Health confirmed that usage and expenditure on PBS drugs was consistent with estimates. The report examines selected approaches used by Health, which have evolved in recent years, to manage the risk of PBS drugs being used outside subsidy conditions. The report also acknowledges and describes the role of the expert committees. The scope of the audit was limited to PBS drugs for which Health pays a subsidy. The audit did not examine Health's role in educating consumers, prescribers, and other health professionals, or the implications of the Australia–United States Free Trade Agreement for the PBS. Additionally, the ANAO did not form an opinion on the success of Medicare Australia's compliance role. To form an opinion against the audit objective, the ANAO interviewed Health personnel, committee members and stakeholders, examined relevant documents and files, analysed drug usage and expenditure data, and attended a number of committee meetings. To assist the audit process, the ANAO selected a sample of eight drugs. The drugs were selected due to their high cost to the PBS and/or high usage, or because the drug has had a particularly interesting PBS history. The sample is not representative of all drugs on the PBS. In 2004–05, 15.3 million prescriptions were written for these eight drugs, with the Government subsidy totalling $1.05 billion.

This annual report documents the performance of the Australian National Audit Office (ANAO) in the financial year ended 30 June 2024. The report addresses all applicable obligations under the Public Governance, Performance and Accountability Act 2013; the Public Governance, Performance and Accountability Rule 2014; the Auditor-General Act 1997; the performance measures set out in the outcome and programs framework in the ANAO’s Portfolio Budget Statements 2023–24 and in the ANAO Corporate Plan 2023–24; and annual reporting requirements set out in other relevant legislation.

The Australian National Audit Office (ANAO) publishes two reports annually addressing the outcomes of the financial statement audits of Australian government entities and the Consolidated Financial Statements (CFS) of the Australian Government, to provide the Parliament of Australia with an independent examination of the financial accounting and reporting of public sector entities. This report focused on the results of the interim audit phase, including an assessment of entities’ key internal controls, of the 2017–18 financial statements audits of a range of entities including all departments of state and a number of major Australian government entities.

The Australian National Audit Office (ANAO) publishes two reports annually addressing the outcomes of the financial statement audits of Australian government entities and the Consolidated Financial Statements (CFS) of the Australian Government to provide Parliament an independent examination of the financial accounting and reporting of public sector entities. This report focuses on the results of the interim audit phase, including an assessment of entities’ key internal controls, of the 2016–17 financial statements audits of 25 entities including all departments of state and a number of major Australian government entities.

The objective of this follow-up audit was to provide assurance to the Parliament on the cost-effectiveness of public sector travel by:

• ascertaining the degree of acceptance, and the extent of implementation, of the previous audit recommendations and better practice principles; and
• establishing whether organisations were managing travel effectively, taking into consideration recommendations and findings detailed in the above Audit Reports and the Better Practice Guide Public Sector Travel.

The ANAO’s performance audit program is one of the main assurance functions of the Auditor-General. The purpose of this information report was to provide analysis of 2023–24 performance audits.

This report focuses on the results of the interim audits, including an assessment of entities’ key internal controls, supporting the 2018–19 financial statements audits. It examines 26 entities, including all departments of state and a number of major Australian government entities. The entities included in the report are selected on the basis of their contribution to the income, expenses, assets and liabilities of the 2017–18 Consolidated Financial Statements of the Australian Government (CFS). Significant and moderate findings arising from the interim audits are reported to the responsible Minister(s), and all findings are reported to those charged with governance of each entity.

The objective of the audit was to assess whether selected regulatory agencies have cost recovery procedures and practices which comply with the Government's guidelines. To address this objective, the audit assessed the management of cost recovery against the following criteria:

• regulatory agencies have clear and consistent cost recovery procedures to identify their activities and costs, and set fees and levies;
• regulatory agencies have effectively implemented their cost recovery procedures;
• regulatory agencies regularly monitor and review their cost recovery activities; and
• regulatory agencies regularly report on their cost recovery.

The report summarises the audit and other related activities of the ANAO in the period June to December 2000. It provides a consolidated report of the ANAO's integrated audit products tabled during the period. Key issues examined in the ANAO's performance audit activity in the period were:

• risk management in a corporate governance framework;
• outsourcing and asset sales;
• contract management;
• service delivery;
• data management/management information systems; and
• legislative implementation.

The report also summarised the results of a report summarising the final results of the audits of the financial statements of Commonwealth entities; and dealt with issues regarding financial management issues, controls and processes arising from the financial audit activities conducted during the period.

This report focuses on the results of the interim financial statements audits, including an assessment of entities’ key internal controls, supporting the 2019–20 financial statements audits. This report examines 24 entities, including all departments of state and a number of major Australian government entities. The entities included in the report are selected on the basis of their contribution to the income, expenses, assets and liabilities of the 2018–19 Consolidated Financial Statements (CFS). Significant and moderate findings arising from the interim audits are reported to the responsible Minister(s), and all findings are reported to those charged with governance of each entity.

The objective of the audit was to examine the investment of public funds by selected entities, including: compliance with relevant legislation, delegations and instructions; the value for money of investment strategies; and reporting of investment activities. Six entities were selected for audit, comprising three FMA Act agencies and three Commonwealth authorities. The six entities had aggregrate investments of $1.64 billion as at 30 June 2004 and realised investment earnings of some $80.4 million during 2003/04.

The ANAO prepares two reports annually that provide insights at a point in time to the financial statements risks, governance arrangements and internal control frameworks of Commonwealth entities, drawing on information collected during our audits.

This report is the first of the two reports and focuses on the results of the interim financial statements audits, including an assessment of entities’ key internal controls, supporting the 2023–24 financial statements audits. This report examines 27 entities, including all: departments of state; the Department of Parliamentary Services; and other Commonwealth entities that significantly contribute to the revenues, expenses, assets and liabilities within the 2022–23 Australian Government Consolidated Financial Statements (CFS). The National Indigenous Australians Agency is also included in this report given the role it plays working across government with indigenous communities and stakeholders.

This report is the first in the series of reports for the 2020–21 financial year and focuses on the results of the interim audits, including an assessment of entities’ key internal controls, supporting the 2020–21 financial statements audits. This report examines 25 entities, including all departments of state and a number of major Australian government entities. The entities included in the report are selected on the basis of their contribution to the income, expenses, assets and liabilities of the 2019–20 Consolidated Financial Statements.

The Australian National Audit Office (ANAO) publishes two reports annually addressing the outcomes of the financial statement audits of Commonwealth entities, and the Consolidated Financial Statements of the Australian Government, to provide Parliament an independent examination of the financial accounting and reporting of public sector entities. This report focuses on the results of the interim audit phase, including an assessment of entities’ key internal controls, of the 2015–16 financial statements audits of 21 departments and other major General Government Sector (GGS) entities. These entities contribute 95 per cent of GGS revenues and expenses.

The objective of the audit was to assess the effectiveness of Agriculture’s and Customs’ arrangements for the targeting and screening of incoming international mail to identify prohibited and restricted goods.

The report summarises performance audit, financial statement audit and other related activities for the ANAO for the period July to December 2003. The key issues arising from performance audits tabled in this period are summarised against the ANAO themes. The report also summarises financial audits and other financial audit activities conducted by the ANAO during the period July to December 2003. It discusses significant issues such as the: consolidated financial statements and the final budget outcome; harmonisation of Australian Generally accepted accounting practices and Government Finance Statistics; adoption of International Financial Reporting Standards; timing for Financial Statements Preparation; and the audit of the CFS 2002-03.

The objective of the audit was to assess the administrative effectiveness of the CCAS. The audit focused on the following key areas: targeting non-compliance; real time compliance activity; post transaction compliance activity; and planning and performance evaluation. As the imports phase of the Integrated Cargo System (ICS) was only introduced in October 2005, this system was not reviewed as part of the audit. Our audit programme for 2005–06 includes ICS as a potential audit topic.

The report summarises the audit and other related activities of the ANAO in the period January to June 2001. Key issues arising from performance audits tabled in this period are summarised against ANAO themes of:

• corporate governance including human resource management, financial management, and performance information;
• service delivery including the impact of e-government;
• procurement and contract management; and
• information technology.

Appendix 1 of the Activity Report provides a short summary of each of the performance audits tabled between 1 January 2001 and 30 June 2001.

The objective of the audit was to assess the effectiveness of the administration of the Australian Prudential Regulation Authority (APRA) financial industry levies.