Strategy two: Maintain regulatory science capability to deliver high-quality decision making that is timely, science based and proportionate to the risks being managed
Summary and explanation of performance
In 2018–19 we improved our regulatory processes with 85 per cent of applications processed within statutory timeframes, and we finalised around 3000 applications. We processed 7126 adverse experience reports and took regulatory action on one product family to ensure that its use remains safe and efficacious. We also completed stage one of our chemical review into chlorpyrifos and have proposed to cancel its use in domestic and home garden settings, and in some public spaces.
Focus areas and activities
High-performing organisation:
- develop a learning and development strategy for on-boarding and capability development of new workforce
- establish the Office of the Chief Regulatory Scientist
- continue delivery of the APVMA accelerated regulatory science training program— Diploma of Government (Regulatory Science)
- deliver regulatory training
- renew online learning modules
- maintain and update procedures and material
- embed management practices for the enterprise risk framework.
Implement reforms and independent review recommendations:
- implement high-priority recommendations identified in the independent review
- monitor and report on benefits realised through the Agricultural Competitiveness White Paper
- work with the Department of Agriculture and Water Resources to pursue efficiencies through legislative reform, advocating recommendations made in the independent review.
Maintain alignment with international best practice:
- continue engaging and harmonising with relevant international forums
- periodically review and update APVMA risk assessment manuals and data guidelines to align with relevant international standards.
Performance measure |
Source |
Result |
---|---|---|
Maintaining a low number of regulatory decisions which are overturned by external bodies such as the Administrative Appeals Tribunal or Court |
Corporate Plan 2018–19 |
In the 2018–19 year, the APVMA had 1 regulatory decision upheld (with minor amendments) by the Administrative Appeals Tribunal. This is an improvement on 1 decision overturned in 2017–18 and 4 decisions overturned in 2016–17. |
Adjustments to registration requirements and the cancellation of registration for safety reasons flowing from the Adverse Experience Reporting Program (AERP) |
Operational Plan 2018–19 |
In 2018–19, the APVMA processed more than 7126 adverse experience reports. One adverse incident may be reported multiple times (eg the vet, consumer and registrant may all report the same incident). The total number of reports received includes duplicate reports and reports classified as unrelated to the registered product. 951 classified reports have been classified as related to:
No safety issues were identified that warranted the cancellation of any product registrations; however, as a result of the receipt, classification and analysis of adverse experience reports received this year, the APVMA took regulatory action on 1 product family to ensure that its ongoing use remains safe and efficacious. Data from the AERP were also provided to inform registration and permit applications, compliance matters and chemical review processes. |
APVMA contributions made to international forums |
Operational Plan 2018–19 |
APVMA staff made presentations and attended several international forums during 2018–19 (see Corporate governance and management). |
Maintaining a 24-month review cycle for APVMA risk assessment manuals and data guidelines |
Regulator performance framework |
The APVMA has published the following manuals:
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Incremental improvement in operational performance against legislative timeframes:
|
Operational Plan 2018–19 |
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Increased number of compliant manufacturing facilities that qualify for a reduced audit interval of up to 36 months |
Operational Plan 2018–19 |
The APVMA continues to reduce the regulatory burden and cost of compliance for regulated entities by employing a risk-based approach for auditing manufacturers of veterinary medicines. Audit intervals are broken into 4 categories, and facilities are assigned to each category based on:
At 30 June 2019, 54% of compliant manufacturing facilities qualified for an audit interval of 24 months or greater, with 6% qualifying for an audit interval of greater than 36 months. |
Reduced burden and reduced cost for compliant manufacturers |
Operational Plan 2018–19 |
In 2018–19:
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Faster processing of nontechnical applications and minor variations |
Operational Plan 2018–19 |
Non-technical assessments have assessment periods of 3 months or less and have no technical assessment The APVMA finalised non-technical assessments in an average of 2.4 months in 2018–19, down from an average of 2.6 months in 2017–18 |
The number of applications using data assessment, standards and decisions from comparable regulators |
Operational Plan 2018–19 |
In 2018–19, international assessments contributed to the assessment of 16 products. They also supported residues assessment of 24 minor use or emergency permits |
The average reduction in assessment time achieved for applications using international data |
Operational Plan 2018–19 |
For the 2 products that were finished in the year which were substantively supported by international assessments and project plans agreed with the applicants, finalisation occurred 10 and 13 months before the statutory finalisation date |
Visit
https://www.transparency.gov.au/annual-reports/australian-pesticides-and-veterinary-medicines-authority/reporting-year/2018-2019-22