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:

• animal health—62.0%
• efficacy—25.0%
• human health—9.7%
• crop health—0.8%
• environment—2.4%.

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:

• Environment: apvma.gov.au/node/46416
• Chemistry and Manufacture: apvma.gov.au/node/45566
• Health: apvma.gov.au/node/45571
• Residues and Trade: apvma.gov.au/node/45576

Incremental improvement in operational performance against legislative timeframes:

• 70% of regulatory decisions completed within statutory timeframes
• 50% of emergency permits finalised within 14 days and 90% finalised within 28 days
• 100% of chemical reconsiderations finalised in accordance with the program schedule.

Operational Plan 2018–19

• 85% of regulatory decisions for products, permits and active constituents were completed within statutory timeframe
• 36% of emergency permits were completed within 14 days, and 67% were completed within 28 days
• chemical reconsiderations finalised:

1. in August 2018 the methiocarb Proposed Regulatory Decisions report was published, for a consultation period of three months
2. in October 2018, in response to spray drift associated with 2,4 –D, product labels were suspended and new label instructions were issued at the same time to reduce the risk of spray drift
3. in June 2019, the chlorpyrifos review first stage (concerning home garden and domestic uses) was progressed. We made a proposed regulatory decision to suspend and cancel all home garden and domestic chlorpyrifos products, and to remove uses from certain public spaces.

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:

• the non-conformance score obtained from the Good Manufacturing Practice audit
• product-related factors (category of licence) to provide an overall risk valuation
• the combined risk valuation of the subsequent audit interval
• risk assessment matrix.

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:

• 19 audits increased audit interval in comparison to previous intervals, resulting in a reduction in the burden to industry
• 10 remained the same as the previous interval with no increase in burden.

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