Improving the quality and efficiency of assessment

Fact Sheet No. 3

The current assessment timeframes do not take into account the total time elapsed for considering an application. This does not provide for certainty and predictability in assessment timeframes for applicants or the APVMA. In some cases, a further concern is the poor quality applications that are submitted and then maintained in the system because of industry concerns about losing data protection. In addition, applicants may provide data for the APVMA’s consideration at any time. These existing arrangements result in an unnecessary drain on the APVMA’s assessment resources and delays in the finalisation of assessments.

The Better Regulation of Agricultural and Veterinary Chemicals reforms¹ address these problems by introducing ‘shut the gate’ provisions that require the APVMA to only consider information it received when the application was made, or in response to a request by the APVMA, or under the legislative obligations to provide new relevant information. The reforms introduce timeframes for assessments that are measured against the total time elapsed from acceptance to finalisation. The reforms also provide for a single extension of the elapsed time to allow for an applicant to provide information required by the APVMA. Combined with the ‘shut the gate’ provisions, these measures will enhance the APVMA’s ability to finalise assessments in a consistent and predictable timeframe.

Improvements to the approval and registration system

The reforms require the APVMA to refuse inferior or deficient applications so that it only need assess applications that are of the required standard. New provisions will preserve access to data protection where applications are refused or voluntarily withdrawn. The proposed ‘shut the gate’ measures prevent an applicant delaying an evaluation by volunteering more information after an application has been received.

The reforms introduce timeframes for chemical reviews, with specific provisions for the timing of data submission and ‘shut the gate’ provisions similar to those for approval and registration. This will help reduce the current backlog and will provide predictability for the completion of these reviews.

Overseas data, assessments and regulatory decisions are currently used in Australia’s regulatory system. The reforms ensure that there is no impediment to the APVMA’s use of these overseas assessments and data, providing the assessments are conducted by agencies that are comparable to the APVMA and that overseas data are relevant to Australian conditions, agricultural practices and animal husbandry.

Electronic Communication

The reforms will enhance the APVMA’s ability to utilise electronic communication between it and applicants, registrants and approval holders. Electronic lodgement of applications would streamline the APVMA’s internal administrative processes and reduce the potential for submission of incorrect or incomplete applications, which would subsequently be refused.