Audits
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APVMA Quality Management System
The APVMA maintains strong controls over its key processes to ensure its legislative obligations are met. The APVMA quality management system emphasises responsiveness to customers and stakeholders, consistency of output, efficient resource management and continuous improvement. It is reviewed and monitored by a monthly managers' meeting and is subject to internal and external audit.
Audit Committee
The APVMA Audit Committee is an essential part of the APVMA’s governance and risk framework.
Please see full details about the APVMA's Audit Committee.
Fraud Control
The APVMA has a Fraud Risk Assessment and a Fraud Control Plan in place that complies with the Australian Government's Commonwealth Fraud Control Guidelines. The Fraud Control Plan includes fraud prevention, detection, investigation, reporting and data collection procedures.
Auditor-General's Reports
The Australian National Audit Office (ANAO) conducted a performance audit of the APVMA in 2006. The audit was extensive and assessed whether the APVMA was delivering its key regulatory functions effectively.
Scope
The ANAO examined APVMA 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.
Report
The ANAO audit report ‘Regulation of Pesticides and Veterinary Medicines’ was released on 7 December 2006. It contained six recommendations dealing with:
- improved management of conflict of interest for advisory committees and service providers
- improving reporting and transparency of registration timeframe performance
- strategies for improving the quality of applications
- the arrangements for receiving scientific advice from government agencies
- improving the Manufacturers Licensing Scheme
- optimising the management of throughput and transparency within the Chemical Review Program.
In addition to the recommendations, the ANAO offered additional suggestions in the text of the ANAO audit report (PDF, 1.5Mb).
Implementation
The APVMA welcomed the report and agreed with all recommendations. The report acknowledges various initiatives that the APVMA has introduced in recent years to improve the effectiveness of its operations. However, the arena of chemicals regulation is constantly changing and the report provides valuable recommendations for further improvements.
Such an in-depth external audit provides confidence to stakeholders that the APVMA is effectively performing its responsibilities described in its governing legislation.
The APVMA has developed a comprehensive plan to implement all the ANAO recommendations and additional suggestions. In brief the APVMA will:
- strengthen existing conflict of interest provisions for external service providers and consultative committees;
- improve recording, monitoring and reporting of registration timeframes;
- periodically identify, and inform industry, of types of defects in registration applications;
- review arrangements for seeking scientific advice from other Australian government agencies;
- further improve auditing processes for the Manufacturing Licensing Scheme; and
- review the Chemical Review Program to assess the adequacy of the current approach and increase communications of progress of reviews.
The implementation process is well underway. Information on progress against the implementation actions is available from the APVMA’s implementation plan (PDF 102kb) which is updated regularly.
The implementation of the ANAO recommendations and suggestions will further improve the effectiveness of delivery of the APVMA’s regulatory functions.