INTRODUCTION > SUMMARY NEW ZEALAND AUSTRALIA 100% (Hazardous Substances and New Organisms Act) and 69% of applications completed within statutory timeframe approximately 55% (Health and Safety at Work Act) applications within Quarterly performance reporting statutory timeframe Variability in quality of applications accepted Example of the use of independent third party data assessors Clock extended not stopped when awaiting response/s from enabling much shorter legislative time frames (40 days) applicant Strong stance/posture with regard to application quality CANADA Application completeness check (including data review) prior to acceptance Performance target of 90% with actual results of: Registration Review Project may have lessons learnt applicable to the 87% (Cat A), 88% (Cat B) and 95% (Cat C) APVMA Times and target set in policy not legislation Fees cost recovered based on actual work undertaken Review times are generally longer than those set in Australia Review times do not include finalisation after decision EUROPEAN UNION Clock stops when awaiting response/s from applicant European Commission & European Food Safety Authority: 75% (2016) PMRA may re-negotiate review timeline with applicant and Rapporteur Member States: “delays are commonplace”1 Completeness check includes format, data and fee requirements Strong stance/posture with regard to application quality BRAZIL Progress of EU Pesticide Legislation Review (2017-19) will be of interest The time required for registration can be up to 6 years² as opposed Actions resulting from the audits carried out in EU Member States in to the targeted 120 days 2016 and 2017 will be of interest Applications pending review is almost 6 times the number evaluated The UK has demonstrated the increasing complexity of assessments Overview Report on a Series of Audits Carried Out In EU Member States in 2016 and 2017 in Order to Evaluate the Systems in Place for the Authorisation of Plant Protection Products 1 ² Chemlinked, Brazilian Pesticide Regulation Overview, March 13, 2017
INTRODUCTION > SUMMARY AUSTRALIA 69% of applications completed within statutory timeframe Quarterly performance reporting Variability in quality of applications accepted Clock extended not stopped when awaiting response/s from applicant CANADA Performance target of 90% with actual results of: 87% (Cat A), 88% (Cat B) and 95% (Cat C) Times and target set in policy not legislation Review times are generally longer than those set in Australia Review times do not include finalisation after decision Clock stops when awaiting response/s from applicant PMRA may re-negotiate review timeline with applicant Completeness check includes format, data and fee requirements BRAZIL The time required for registration can be up to 6 years² as opposed to the targeted 120 days Applications pending review is almost 6 times the number evaluated NEW ZEALAND 100% (Hazardous Substances and New Organisms Act) and approximately 55% (Health and Safety at Work Act) applications within statutory timeframe Example of the use of independent third party data assessors enabling much shorter legislative time frames (40 days) Strong stance/posture with regard to application quality Application completeness check (including data review) prior to acceptance Registration Review Project may have lessons learnt applicable to the APVMA Fees cost recovered based on actual work undertaken EUROPEAN UNION European Commission & European Food Safety Authority: 75% (2016) and Rapporteur Member States: “delays are commonplace”1 Strong stance/posture with regard to application quality Progress of EU Pesticide Legislation Review (2017-19) will be of interest Actions resulting from the audits carried out in EU Member States in 2016 and 2017 will be of interest The UK has demonstrated the increasing complexity of assessments 1 Overview Report on a Series of Audits Carried Out In EU Member States in 2016 and 2017 in Order to Evaluate the Systems in Place for the Authorisation of Plant Protection Products ² Chemlinked, Brazilian Pesticide Regulation Overview, March 13, 2017
28811-final_apvma_report_20171222.docx