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.

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.

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 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.