OPPORTUNITIES FOR IMPROVING KPI 1.3 ACHIEVEMENT Change Impacts On: Opportunities for the APVMA to ID Opportunity People Process Leg Rec improve its assessment Technology Data/Info performance range from improving guidance material and improving Prioritise applications based on the value of the risk assessment processes to 1. product to Australia’s agriculture market and use R2.3 ✓ ✓ ✓ amending legislation and using prioritisation tools for module assessments (like more external assessors. ROCI) Improve the guidance and data requirement 2 descriptions for industry, third parties and for ✓ ✓ ✓ All This table frames the opportunities APVMA staff (supported by ANAO Audit1) across people, process, technology Require that PAA (level 2) is undertaken for all Item (which includes data and 10s, and/or any modular assessments. This should information) and legislation (Leg). 3. include data analysis activity. Alternatively, require that R1.3 ✓ ✓ ✓ ✓ The relevant recommendations are these assessments are submitted by regulatory listed at the far right of the table consultants (Rec). Begin evaluation planning at day 7 of pre-assessment (before payment)-when data is available to start We have harvested these 4. checking the categorisation of modules for assessment. R1.3 ✓ ✓ ✓ opportunities from engagements Use 8G rejection at pre-assessment, if categorisation by and analysis, as outlined in pages the client is incorrect Each assessment team (Chem/Tox/Env etc) should have streamlined processes for screening new assessments These opportunities do not include so that data can be reviewed early in the assessment system improvements already 5. time. Dedicated staff should be used to streamline R2.3 ✓ ✓ ✓ planned such as label changes to applications and to reduce backlogs. Managers should fast track notifiable variations, the use the portal to support prioritisation and workload changes underway to make management efficacy and safety level 3 an Develop a strategy to define the use of regulatory automatic module for item 21s and consultants and external scientific service providers 6. the Streamlining Application to undertake assessments and reduce backlogs for R1.2 ✓ ✓ ✓ ✓ Processes Project. APVMA. How can the APVMA increase trust in third party assessors? Can APVMA train and certify them? The Auditor-General ANAO Report N0. 56 1. (2016-17). Performance Report: Pesticide and Veterinary Medicine Regulatory Reform
OPPORTUNITIES FOR IMPROVING KPI 1.3 ACHIEVEMENT Opportunities for the APVMA to improve its assessment performance range from improving guidance material and improving risk assessment processes to amending legislation and using more external assessors. This table frames the opportunities across people, process, technology (which includes data and information) and legislation (Leg). The relevant recommendations are listed at the far right of the table (Rec). We have harvested these opportunities from engagements and analysis, as outlined in pages These opportunities do not include system improvements already planned such as label changes to fast track notifiable variations, the changes underway to make efficacy and safety level 3 an automatic module for item 21s and the Streamlining Application Processes Project. 1. The Auditor-General ANAO Report N0. 56 (2016-17). Performance Report: Pesticide and Veterinary Medicine Regulatory Reform Change Impacts On: ID Opportunity People Process Technology Data/Info Leg Rec 1. Prioritise applications based on the value of the product to Australia’s agriculture market and use prioritisation tools for module assessments (like ROCI) ✓ ✓ ✓ R2.3 2 Improve the guidance and data requirement descriptions for industry, third parties and for APVMA staff (supported by ANAO Audit1) ✓ ✓ ✓ All 3. Require that PAA (level 2) is undertaken for all Item 10s, and/or any modular assessments. This should include data analysis activity. Alternatively, require that these assessments are submitted by regulatory consultants ✓ ✓ ✓ ✓ R1.3 4. Begin evaluation planning at day 7 of pre-assessment (before payment)-when data is available to start checking the categorisation of modules for assessment. Use 8G rejection at pre-assessment, if categorisation by the client is incorrect ✓ ✓ ✓ R1.3 5. Each assessment team (Chem/Tox/Env etc) should have streamlined processes for screening new assessments so that data can be reviewed early in the assessment time. Dedicated staff should be used to streamline applications and to reduce backlogs. Managers should use the portal to support prioritisation and workload management ✓ ✓ ✓ R2.3 6. Develop a strategy to define the use of regulatory consultants and external scientific service providers to undertake assessments and reduce backlogs for APVMA. How can the APVMA increase trust in third party assessors? Can APVMA train and certify them? ✓ ✓ ✓ ✓ R1.2
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