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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 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.
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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 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 objective of the audit was to assess the effectiveness of the Australian Pesticides and Veterinary Medicines Authority’s (APVMA’s) implementation of reforms to agvet regulation and the extent to which the authority has achieved operational efficiencies and reduced the cost burden on regulated entities.
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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.
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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).
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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 development and administration of the Fifth Community Pharmacy Agreement (5CPA), and the extent to which the 5CPA has met its objectives.
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The Audit Activity Report: July to December 2004 summarises the activity and outputs of the Australian National Audit Office for the first half of the 2004-05 reporting year. The Report outlines the key findings of performance and financial control audits, and summarises audits tabled and better practice guides during July to December 2004.
The objective of the audit was to determine the effectiveness of DoHA's administration of the MoU between the Government and the pathology profession, including monitoring whether the MoU is achieving its objectives
This annual report documents the performance of the Australian National Audit Office (ANAO) in the financial year ending on 30 June 2005. It includes highlights and areas of focus for the year; a forward by the Auditor-General; an overview of the report; a report on performance; details about management and accountability, and the financial statement for the year.
This annual report documents the performance of the Australian National Audit Office (ANAO) in the financial year ending on 30 June 2012. It presents an overview including the role and vision of the Office, a report on performance, details about management and accountability, and the financial results.
The objective of the audit was to assess the implementation and effectiveness of the enhanced grants administration requirements for:
- reporting to the Finance Minister on the awarding of grants within their own electorate by Ministers who are Members of the House of Representatives;
- reporting to the Finance Minister on instances where Ministers have decided to approve a particular grant which the relevant agency has recommended be rejected; and
- the website reporting of grants awarded.
The audit objective was to assess the effectiveness of Health's implementation of the Diagnostic Imaging Review Reform Package, some three years into the five year reform period.
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To assess the extent to which agencies create, manage and dispose of records in accordance with key business, legal and policy requirements.
The agencies included in the audit were the: Australian Customs and Border Protection Service (Customs); Department of Immigration and Citizenship (DIAC); and the Department of the Treasury (Treasury). The audit also considered the Archives' response to Recommendation No. 1 from ANAO Audit Report No.6 2006, 07 Recordkeeping including the Management of Electronic Records, including whether they had clarified Australian Government records management requirements for agencies.
Mr Ian McPhee - Auditor-General for Australia, presented to the Australian Institute of Company Directors, in conjunction with the Institute of Internal Auditors Australia
The objective of the audit was to assess the effectiveness of the Department of Climate Change and Energy Efficiency’s implementation and administration of the National Greenhouse and Energy Reporting Scheme.
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.
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This annual report documents the performance of the Australian National Audit Office (ANAO) in the financial year ending on 30 June 2004. It includes highlights and areas of focus for the year; an introduction by the Auditor-General; an overview of the report; a report on performance; details about management and accountability, and the financial statement for the year.
The objective of the audit was to examine the effectiveness of CSP’s feedback management system. CSP’s performance was assessed against the following criteria:
- CSP has appropriate channels to collect customer feedback;
- CSP effectively manages and resolves complaints; and
- CSP accurately reports on customer feedback, and analyses the information to improve aspects of child support administration.
The audit objective was to assess the effectiveness of DEEWR's administration of the National Partnership Agreement on Literacy and Numeracy (LNNP). The three high-level audit criteria used to form a conclusion examined the extent to which DEEWR:
- established sound administrative and payment arrangements consistent with government policy, including through its negotiation of bilateral agreements, implementation plans and reform targets;
- properly managed administrative and payment arrangements; and
- effectively monitored and reported on delivery and outcomes.
The objective of the audit was to assess the effectiveness of the administration of the Australian Prudential Regulation Authority (APRA) financial industry levies.
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The audit objective was to assess the effectiveness of DEEWR‘s administration of the initial phases of the NP ECE. The high-level criteria used to make this assessment were the appropriateness of DEEWR‘s:
- establishment of a sound foundation for implementation, including implementation plans, monitoring arrangements and an Indigenous strategy for universal access; and
- ongoing monitoring and support activities, including assessing progress reports, making payments, maintaining relationships, improving data quality and public reporting.
The objective of the audit was to provide an independent assurance of the effectiveness of Defence's management of the acquisition, and future provision of the Armidale Class Patrol Boats capability, relating to the in-service support contract, provision of infrastructure, and crewing sustainability.
The objective of the audit was to assess the administrative effectiveness of DEST's support for the Australian education and training export industry, including its regulatory and associated roles, and how it monitors and reports on its performance in undertaking these roles.
The objective of the audit was to assess the effectiveness of Centrelink’s QOL control, which supports the integrity of payments administered by DHS on behalf of the Australian Government.
The audit objective was to assess the effectiveness of DEEWR’s administration of FWEIP. The three high level criteria that were used to make this assessment were the appropriateness of DEEWR’s:
- program planning and design;
- selection and engagement of providers; and
- program monitoring, reporting and evaluation.
The objective of the audit was to assess the effectiveness of FaHCSIA’s administration of the HAF. To address this objective, the Australian National Audit Office (ANAO) assessed FaHCSIA’s administration against a range of audit criteria, including the extent to which:
- assessment and approval processes were soundly planned and implemented, and were consistent with the requirements of the overarching financial management framework;
- appropriately structured funding agreements were established and managed for each approved grant; and
- the performance of the HAF, including each of the funded projects, was actively monitored and reported.