Annual Report 2015-16—Chapter 3: Annual performance statement

Introduction

The APVMA is an independent statutory authority responsible for the assessment and registration of agvet chemicals.

The 2015–16 annual performance statement of the APVMA is provided to meet the requirements under paragraph s39(1)(a) of the Public Governance, Performance and Accountability Act 2013 (PGPA Act). The statements reflect the performance of the entity and comply with subsection 39(2) of the PGPA Act.

There have been no variations from the PBS in 2015–16.

About the annual performance statement

The Performance Indicators (PI) presented in this statement are drawn from:

  • the APVMA portfolio budget statement
  • the APVMA corporate plan 2015–19
  • the APVMA regulator performance framework 2015–16.

These documents cover performance relating to:

  • timely regulatory decision making
  • removal of unnecessary impediments
  • communication
  • approaches to regulatory risk
  • compliance and monitoring
  • transparency
  • enhancing regulatory frameworks
  • regulatory science
  • operating as a high-performing organisation.

Presented in this statement are the metrics underneath each performance indicator and a high-level summary of the outcomes for 201516. Cross-references to the APVMA regulator performance framework are provided.

Information is provided as required to provide further explanation of performance.

The individual activities the APVMA undertook in 201516, as contained in the operational plan, directly relate to the performance indicators discussed in this statement. A report on progress of the activities in the 201516 operational plan is in Appendix A.

Timely regulatory decision making

In 201516, the APVMA commenced assessment of 5106 applications covering:

  • pre-application assistance
  • pesticide and veterinary medicine products
  • active constituents
  • permits
  • nominated agents and changes to holders (Items 8L, 8M and 8P)
  • technical assessments under Item 25
  • notifiable variations
  • import consents
  • certificates of exports.
Table 6: Summary of activities related to regulatory decisions in the APVMA July 2015 – June 2016
Types of regulatory 
decisions
Commenced Finalised/issued In PRogress
Pre-application assistance 175 145 42
Product registration—pesticides 905 1029 408
Product registration—veterinary medicines 701 704 316
Actives 342 213 289
Permits 562 599 179
Items 8L, 8M, 8P 695 689 32
Item 25 15 24 12
Notifiable variations 736 696 37
Import consents 608 620 61
Certificates of export 367 429 30
Total 5106 5148 1406
PERFORMANCE INDICATOR: Percentage of applications completed within timeframes
Metric Results RPF reference
Timeframe performance met for 100% product registration* 66% 1.3.B
Timeframe performance met for 100% active approvals* 70% 1.3.B
Timeframe performance met for 100% permits* 70% 1.3.B
90% of consents to import are processed within 14 days 86% 1.3.B
100% of internal review requests addressed within the 90-day timeframe 63% 1.3.B
100% of pre-application assistance timeframes 
are met
(old process) 36% (new process) 46% 1.3.B
Timeframes for chemical reviews are met No chemical reviews were due for completion in 2015–16: however, the review of fenamiphos was completed 
in July 2015
1.3.B

Source: APVMA corporate plan 2015–19APVMA operational plan 2015–16APVMA regulator performance framework (RPF) 2015–16, 2015–16. *Also in Portfolio Budget Statement

Timeframes for products, actives and permits

The APVMA commenced assessment of 2510 applications for products, actives and permits and finalised 2545 applications between July 2015 and June 2016. Of the 2545 product, active and permit applications finalised, approximately 90.5 per cent were granted, with around 2.8 per cent refused by the APVMA and 6.7 per cent of applications withdrawn by the applicants.

The timeframe performance for applications finalised was 68 per cent within timeframe for the year.

Total product application timeframe performance was 66 per cent: pesticides 57 per cent, veterinary medicines 80 per cent, and 70 per cent of applications for actives and permits were completed within timeframe.

There was a significant improvement in timeframe performance for product applications over the last quarter (April–June) of 2015–16 reaching 78 per cent completed within timeframe.

Quarterly performance against timeframes is published on our website under 'Performance statistics' (apvma.gov.au/node/19741).

Table 7: Product, active and permit applications processed by the APVMA 2015–16
Application type Commenced Finalised Finalised within 
timeframe
In progress (end)
Products Pesticides 905 1029 57% 408
Veterinary medicines 701 704 80% 316
Subtotal 1606 1733 66% 724
Actives 342 213 70% 289
Permits 562 599 70% 179
Total 2510 2545 68% 1192

Figure 3: Timeframe performance by application type, per quarter, 2015–16

Timeframe performance by application type, per quarter in 2015–16

 

The overall timeframe performance for the year was negatively affected by higher than expected unplanned staff leave in the September quarter, which caused backlogs for subsequent quarters. However, performance improved significantly towards the end of the year as a result of:

  • the recruitment of staff to the registration management and evaluation program
  • new capacity and improvements to our internal applications management software that reduced administrative burden on APVMA staff
  • improvements to work processes.

Timeframe performance for import consents

The APVMA commenced assessment of 608 applications for import consents and finalised 620 applications between July 2015 and June 2016. Of the 620 applications finalised, 86 per cent were granted within their target timeframe of 14 days for the year, and 98 per cent of applications were issued with two per cent either refused or withdrawn by the applicant.

Table 8: Import consent applications processed by the APVMA 2015–16
Quarter Received Finalised Finalised within
timeframe (%)
Issued In progress
1 150 147 89 144 37
2 115 128 96 126 10
3 138 133 96 130 6
4 205 212 71 205 8
Total 608 620 86 605
(98% of
applications
received)
61

Figure 4: Timeframe performance for import consents 2015–16

Timeframe performance for import consents in 2015–16

 

Timeframe performance for pre-application assistance

The APVMA received 175 applications for pre-application assistance, and finalised 145 applications between July 2015 and June 2016. Of the 145 applications finalised, 41 per cent were granted within their target timeframe.

Target timeframes changed during the year. For the period July–October 2015, the timeframe was one month for all applications. Following feedback from industry and other stakeholders, the APVMA undertook an independent review of the implementation and operation of pre-application assistance arrangements. The review highlighted that the pre-application assistance did not meet the standards required by our clients, and that we did not have adequate systems and processes in place to support it effectively.

The APVMA subsequently re-designed the pre-application assistance arrangements to better 
meet the needs of industry. The new arrangements commenced in November 2015 and now include timeframes and fees that directly relate to the complexity and effort required. There are three tiers of assistance and timeframes of one, two or three months, depending on the type of assistance sought.

Table 9: Applications processed for pre-application assistance by the APVMA 2015–16
Quarter Received Finalised Within timeframe
1 48 38 39
2 33 37 38
3 63 27 77
4 31 43 23
Total 175 145 41

Compliance, enforcement and licensing performance

PERFORMANCE INDICATOR: Percentage of compliance and enforcement activities completed within timeframes
Metric Results RPF reference

GMP audit program implemented as per APVMA-approved schedule

96 audits were completed 
(16 more than the proposed program of 80 audits)

80% of audits were completed within timeframe and a further 9% within one week of the due date—see 'Performance statistics'(apvma.gov.au/node/19741)

1.3.B

100% of statutory notices issued by compliance are gazetted in accordance with legislative requirements

The APVMA issued one statutory notice in 2015–16, which was gazetted in accordance with legislative requirements

1.3.B

Source: APVMA corporate plan 2015–19APVMA operational plan 2015–16APVMA regulator performance framework 2015–16

GMP audits are run through an enforced self-regulation process in which manufacturers are responsible for commissioning their own audits via an authorised auditor. Reminders of audits are sent to manufacturers but audits may sometimes not occur on the due date due to factors such as the unavailability of auditors or delays on the manufacturers' part. In addition, the APVMA has less control over the timeframe where the audit is undertaken by one of our national or international regulatory partners, and some delays may occur.

Removing unnecessary impediments

As an operational regulator, the APVMA is committed to fulfilling its legislative obligations while minimising the burden on the entities we regulate. We do that by understanding the environment within which industry operates, using international data, guidelines and assessments where available, and being as efficient as possible.

PERFORMANCE INDICATOR: Demonstrated understanding of the operating environment for the regulated entities
Metric Results RPF reference

Four stakeholder forums held each year to discuss issues affecting regulated entities

The APVMA held more than four stakeholder forums and meetings with key industry associations throughout 2015–16 to discuss operational and other matters affecting agvet 
chemical regulation

1.1.A

Three industry information and training seminars delivered each year

Three industry information and education sessions were held: 
  • Melbourne, August 2015
  • Canberra, October 2015
  • Melbourne, May 2016

1.1.B

Four industry awareness workshops conducted by APVMA staff each year

The APVMA conducted more than four industry awareness sessions and workshops throughout the year, including a tailored workshop on the lifecycle of product development, and looking at the registration process from the applicant's perspective

1.1.C

Environmental scan published annually

The environmental scan was published as part of the APVMA operational plan 2016–17. See 'Corporate documents' at (apvma.gov.au/node/11026)

1.1.D

Source: APVMA corporate plan 2015–19APVMA operational plan 2015–16 and APVMA regulator performance framework 2015–16

PERFORMANCE INDICATOR: International data guidelines, standards and assessments adopted to reduce effort to register agvet chemicals
Metric Results RPF reference

Demonstrated application of the policy for use of international standards, guidelines, assessments and decisions

There were 492 international guidelines adopted by the APVMA and published on our website. These are available at 'Adopted international technical guidance material—agricultural' and 'Adopted international technical guidance—veterinary'

Two rounds of public consultation on our policy on the use of international standards, guidelines and decisions were undertaken in 2015–16, and implementation will be done in 2016–17

1.2.A

Participation in Global Joint Reviews (GJRs)

Completed: oxathiapiprolin and metacam

Ongoing: bicyclopyrone, flupyradifurone and cyclaniliprole

1.2.B

100% of relevant international standards adopted for new chemical products and chemical review decisions

The APVMA is continuing to apply international standards in risk assessments undertaken for product applications and chemical reviews

1.2.C

Documented justification for the non-adoption of international standards and guidelines

There were no instances of non-adoption

1.2.D

Source: APVMA corporate plan 2015–19APVMA operational plan 2015–16 and APVMA regulator performance framework 2015–16

PERFORMANCE INDICATOR: APVMA business processes are efficient and effective
Metric Results

RPF reference

Satisfaction with APVMA online systems for submitting and managing applications

The APVMA conducted a useability review of online systems in 2015–16 to better understand client needs and to inform improvements to the user experience

Recommendations from the review will be delivered and prioritised in 2016–17

1.3.A

Regulatory decisions are completed within timeframes

The APVMA publishes quarterly performance statistics on regulatory decisions. See 'Performance statistics'

1.3.B

Average decision time for applications by item

Average decision time for applications:
  • products, 5.2 months
  • actives, 8.8 months
  • permits, 3.7 months

1.3.C

Average decision time

The APVMA assesses applications against 29 item numbers across several categories, including product applications, actives and permits. The average decision time for each major category is provided in Table 10.

Table 10: Average duration (months) by item finalised between July 2015 – June 2016 for all post-1 July 2014 applications
    Standard (months) Extended (months)
Type of application Item Actual average duration Legislated assessment period Actual average duration Legislated assessment period
Products New product/active 1 N/A* 18.0 N/A 25.0
2 9.8 Variable (12.5*) 12.9 Variable (14.7*)
New product (existing active) 3 N/A 18.0 N/A 25.0
4 N/A 18.0 N/A 25.0
5 9.0 8.0 15.0 12.0
6 14.1 8.0 12.2 12.0
7 3.7 3.0 7.6 5.0
8 3.2 3.0 4.5 5.0
9 4.1 2.0 3.9 4.0
10 8.3 Variable (7.4*) 8.6 Variable (8.8*)
10A 2.1 Variable (2.0*) N/A Variable (N/A*)
Variations 11 13.7 10.0 21.7 15.0
12 3.3 3.0 6.4 5.0
13 2.2 3.0 N/A 5.0
13A 0.8 1.0 N/A N/A
14 7.2 Variable (6.7*) 10.3 Variable (10.8*)
Actives 15 N/A 14.0 N/A 20.0
16 10.7 9.0 N/A 13.0
17 6.9 7.0 10.0 11.0
18 5.6 7.0 10.5 11.0
Permits 19 2.3 3.0 2.6 5.0
20 2.4 3.0 4.2 5.0
21 5.2 Variable (5.0*) 9.3 Variable
(8.8*)
22 1.1 Variable (2.9*) N/A Variable
23 3.3 Variable (4.1*) 7.4 Variable
(7.1*)
112A 0.5 Variable (0.0*) N/A Variable

N/A – no applications were received for that item in the reporting period.

* Some items have a variable legislated assessment period because they are modular in nature. Each individual application will have a different expected duration. The figure in brackets after the variable text shows the average expected timeframe for these items in this reporting period. This average expected timeframe may change each reporting period, depending on the nature of the applications evaluated by the APVMA.

Analysis of time to complete a product application

In 2015–16, the APVMA employed Oakton, APVMA's external auditors, to run an independent analysis of how long it takes us to complete a product application from the date it is received within the organisation to the date it is finalised.

The consultancy reviewed and compared data for product applications processed within the APVMA under the previous legislation (1 July 2011 to 30 June 2014) to product applications processed under the current legislation (1 July 2014 to 31 March 2016).

Two aspects of performance were considered:

  • proportion of product applications finalised on time using the current 'elapsed time' method
  • average time in months to finalise an application using the current 'elapsed time' method.

A summary of the results provided in the table below shows large improvements in both timeframe performance and average time to finalise after the introduction of the new legislation in July 2014. The report found that:

  • if the same methodology used today was applied to applications prior to 2014, the proportion of applications finalised on time would drop from 91 per cent to 33 per cent. (The APVMA has averaged 69 per cent since 2014)
  • the actual (or 'elapsed') time the APVMA takes to finalise applications has decreased by 70% since before 2014.
Table 11: Analysis of time to complete a product application
  1 July 2011 – 
30 June 2014
1 July 2014 – 
31 March 2016

Proportion finalised on time (timeframe performance)

'Clock time'

91%

-

'Elapsed time'

33%

69%

Average time to finalise from lodgement

'Clock time'

3.1 months

-

'Elapsed time'

7.8 months

4.6 months

Number of applications processed

7941

1806

Communication

The APVMA recognises the importance of communicating well with the entities we deal with in the course of performing our functions. We have a strong commitment to stakeholder consultation and we strive to improve the quality of our information, guidance materials and advice on regulatory decisions.

PERFORMANCE INDICATOR: Level of satisfaction with information and guidance materials
Metric Results RPF reference

Feedback from stakeholders about the quality of guidance material

There is a feedback mechanism on every web page containing guidance material

All feedback is assessed and referred to business owners for action

A useability review will be completed in 2016–17 and recommendations will inform further improvement to guidance material

2.1.A

100% of website content is reviewed by the nominated review date

Individual pages and sections of our website were updated as required

A content management system is in place and full automation to prompt business owners to review content will be operational in early 2016–17

2.1.B

Usage of APVMA website

There were approximately 180 000 unique visitors to the APVMA website in 2015–16 and almost 2 million hits on the chemicals database

2.1.C

Number of subscribers to the APVMA regulatory update

Almost 3000 subscribers are receiving the APVMA regulatory update by email

2.1.D

Website meets relevant Australian Government online and accessibility standards

An online usability review conducted in June 2016 confirmed that the APVMA website is substantially compliant with Australian government online and accessibility standards

2.1.E

Source: APVMA corporate plan 2015–19APVMA operational plan 2015–16 and APVMA regulator performance framework 2015–16

PERFORMANCE INDICATOR: Level of satisfaction with the quality and timeliness of advice on decisions
Metric Results RPF reference

Feedback about the quality of pre-application assistance

Of the voluntary feedback received on the pre-application assistance process: 90% of applicants were satisfied with the clarity of advice provided

2.2.A

Customer service 
standards met

The APVMA enquiries team received around 10 000 calls and 12 000 emails in 2015–16

The APVMA implemented a help desk tool in 2015–16 to enable tracking and monitoring of email enquiries. The tracking tool provides the status of each enquiry and monitors response times against the service standards

Phone messages were checked daily by the enquiries team and return calls were made within the one-day standard

An account manager model will be implemented in 2016–17 to further improve customer standards

2.2.B

100% of correspondence provided to applicants and registrants assessed as comprehensive and easily understood

A correspondence improvement project began in 2015–16 with a full audit of all outgoing letters, notices and emails

Feedback from multiple sources and the recent useablity review confirms there is significant scope for improvement, and has identified priority products for action

Implementation of improved correspondence products will commence in 2016–17

2.2.C

Source: APVMA corporate plan 2015–19APVMA operational plan 2015–16 and APVMA regulator performance 
framework 2015–16

A new customer relationship management tool is expected to be implemented in 2016–17, which will support regular reporting. This will improve the experience for applicants and registrants and will enable more quantitative measurement of customer service standards.

PERFORMANCE INDICATOR: Extent and satisfaction with APVMA consultative processes
Metric Results RPF reference

100% of new or major changes to operational policies or guidelines provided to relevant stakeholders for consultation prior to finalisation

The APVMA consulted on all major changes to operational policy and guidelines prior to finalisation

2.3.A

Feedback from key industry stakeholders about the quality of significant APVMA consultation

There is an opportunity for feedback to be provided during all public consultations as part of the submission process

Feedback can also be provided generally via the website and in response to targeted consultation and industry meetings

The APVMA did not receive concerns about the quality of consultation on major changes that were the subject of public consultation in 2015–16

2.3.B

ational plan 2015–16 and APVMA regulator performance frame work 2015–16

The APVMA undertook public consultation on a number of proposed changes to operational policy and development of guidelines in 2015–16, including:

  • redesign of the pre-application assistance framework in conjunction with industry to provide greater certainty for applicants on requirements
  • adoption and use of international standards, guidelines, assessments and data with specific guidance material developed for both agricultural and veterinary chemicals
  • establishing a pilot for applicants to source efficacy assessments prior to application to trial increased contestability in assessments
  • prioritising chemicals nominated for review in consideration of current scientific data and information to establish the forward work program
  • establishment of crop groupings to support improved access to chemicals for minor use
  • updating data guidelines on dairy sanitisers, aquatic exposure and teat disinfectants to improve guidance for industry
  • scheduling and management of good manufacturing practice audits to provide increased flexibility for manufacturers.

Approaches to regulatory risk

The APVMA is focused on exploring ways to reduce the regulatory effort in relation to registration and compliance to ensure the resources of industry and the regulator are best targeted. We aim to have clear risk management frameworks, we actively seek to take a lower regulatory approach to registration and we take a risk-based approach to compliance.

PERFORMANCE INDICATOR: Risk management frameworks and policies are in place and regularly assessed
Metric Results RPF reference

Documented compliance and enforcement strategy, including options for graduated compliance, 
in place

The compliance and enforcement strategy, which is underpinned by a risk-based approach is available under 'Corporate documents'

3.1.B

Risk frameworks reviewed every three years

The APVMA undertakes continuous improvement of its risk frameworks

3.1.C

Risk framework applied to registration decision and made accessible to regulated entities*

A conceptual risk assessment framework was developed in December 2015 and discussed with industry at APVMA-run industry sessions

In consultation with industry, the APVMA will undertake a staged implementation of the framework

3.1.A

Source: APVMA corporate plan 2015–19, APVMA operational plan 2015–16 and APVMA regulator performance frame work 2015–16 (*Only RPF)

The APVMA is continuing to look at ways to reduce regulatory burden on industry when submitting applications for the registration of agvet chemicals. The goal is to develop new and more efficient registration processes, and the following initiatives fall within the scope of this work:

  • profiling applications to identify those suitable for a low regulatory approach
  • identifying alternative pathways for registration and approval of these applications
  • using international assessments to streamline the scientific assessment process
  • exploring contestable assessment services.

The APVMA has developed a plan for gradually introducing these alternative, more efficient pathways over the next two years. Further information on these initiatives are detailed on the APVMA website.

PERFORMANCE INDICATOR: Lower regulatory effort is applied to activities of lower regulatory risk
Metric Results RPF reference

100% of applications assessed as low regulatory risk processed according to risk-based assessment framework tools and mechanisms

The APVMA is continuing to explore alternative regulatory mechanisms and processes to reduce regulatory burden on industry

3.2.A

Documented approaches in place to review level of regulatory effort applied to agvet chemical registration and approval

Reports and progress updates for the lower regulatory approaches to registration project are available at 'Lower regulatory approaches to registration'

3.2.B

Source: APVMA corporate plan 2015–19, APVMA operational plan 2015–16 and APVMA regulator performance frame work 2015–16

PERFORMANCE INDICATOR: Compliance and enforcement strategies are consistent with agreed risk management policies
Metric Results RPF reference

Compliance and enforcement strategy to be accessible to regulated entities

The compliance and enforcement strategy, which was released on 
25 February 2016, is available under 'Corporate documents'

3.3.A

100% of allegations of non-compliance assessed and/or investigated according to APVMA compliance and enforcement strategy

100% of allegations have been assessed or investigated under this strategy

3.3.B

100% of compliance allegations are risk-assessed prior to the start of enquires

100% of the 204 allegations received during 2015–16 were risk-assessed as follows:

  • 75% low risk
  • 24% medium risk
  • 1% high risk

NA

Documented policy for determining GMP audit schedules to be accessible by regulated entities

The GMP audit policy is available at 'Risk-based scheduling of GMP audits'

3.3.C

Source: APVMA corporate plan 2015–19, APVMA operational plan 2015–16 and APVMA regulator performance frame work 2015–16

Compliance and monitoring

Compliance and monitoring is an important component of the APVMA's work to maintain and build the integrity of the regulatory system for agvet chemicals. We ensure that there is a range of regulatory responses that can be tailored to each circumstance, we are responsive to business needs and we do not create duplication or unnecessary impost on the entities we regulate.

PERFORMANCE INDICATOR: Monitoring and enforcement strategies allow for a range of regulatory responses
Metric Results RPF reference

100% of allegations of non-compliance are 
risk-assessed and prioritised within five working days

100% assessed on time:

  • 79% of non-compliance cases were assessed as low risk with resolution achieved through education and negotiated compliance

4.1.A

Usage of compliance tools

  • 1 statutory notice
  • 6 formal warnings
  • 2 infringement notices (totalling $27 000)
  • 1 investigative warrant
  • 230 cases of non-compliance resolved

4.1.B

Source: APVMA corporate plan 2015–19, APVMA operational plan 2015–16 and APVMA regulator performance frame work 2015–16

PERFORMANCE INDICATOR: Compliance activities are responsive to business needs of regulated entities, where relevant
Metric Results RPF reference

100% of audit and inspection schedules designed to minimise overlap with audits from other government regulators

100% of audits designed to minimise overlap. The APVMA coordinates audits with the:

  • Therapeutic Goods Administration
    for 60 veterinary product manufacturers
  • National Association of Testing Authorities Australia for 10 manufacturers
  • international government regulators of overseas sites importing products to Australia

4.2.A

Evidence of compliance activities conducted jointly with other regulators

  • 17 compliance-related activities collaboratively undertaken with the Australian Border Force
  • Six evidentiary certificates provided to state regulators
  • Joint GMP audits not yet started

4.2.B

Source: APVMA corporate plan 2015–19, APVMA operational plan 2015–16 and APVMA regulator performance frame work 2015–16

PERFORMANCE INDICATOR: Information requested from regulated entities is necessary and acted upon
Metric Results RPF reference

Average number of formal requests for information (including notices) provided for each registration application

In 2015–16:

  • 509 first notices were issued based on processing approximately 2500 applications in 2015–16.
  • 58 second notices were issued

4.3.A

Average number of compliance-related requests for information (including coercive notices) for each compliance action involving interaction with a regulated entity

An average of three requests for information

4.3.B

Evidence demonstrates consideration of alternative means of information gathering before coercive information gathering powers are exercised during investigations into compliance of regulated entities

Alternative approaches are included 
in delegate briefs

NA

Source: APVMA corporate plan 2015–19, APVMA operational plan 2015–16 and APVMA regulator performance frame work 2015–16

Transparency

The APVMA is committed to being open and transparent with the entities it regulates. We actively seek feedback from clients and we publish a range of information to ensure stakeholders are fully informed of our performance.

PERFORMANCE CRITERIA: Performance information is published
Metric Results RPF reference

Timeframe performance statistics published quarterly

Statistics published as follows:

  • Q1 and Q2 published in February 2016
  • Q3 published in June 2016—see 'Performance statistics'

(apvma.gov.au/node/19741)

5.1.A

Performance against customer service standards published quarterly

The APVMA enquiries team received around 10 000 calls and 12 000 emails 
in 2015–16

The APVMA implemented a help desk tool in 2015–16 to enable tracking and monitoring of email enquiries

The tracking tool provides the status of each enquiry and monitors response times against the service standards

Phone messages were checked daily by the enquiries team and return calls were made within the one-day standard

5.1.B

Performance against RPF published annually

Performance against the RPF is 
cross-referenced in this annual report

The annual report against the RPF is scheduled to be published by the APVMA in late 2016

5.1.C

100% of decisions to approve or register an agvet chemical published within 10 working days of decision being made

  • 100% achieved
  • All decisions to approve or register an agvet chemical are published every fortnight in the gazette, and can be viewed on our product search database the day after the decision is made

5.1.D

100% of enforceable undertakings accepted by the APVMA are published within 30 days

Not applicable — no enforceable undertakings issued

NA

Source: APVMA corporate plan 2015–19APVMA operational plan 2015–16 and APVMA regulator performance framework 2015–16

The delay in publishing the first quarter performance statistics was due to changes in our internal software systems, and to difficulty in extracting the information in a timely manner. Because of this delay, we published the first and second quarter information together in February 2016.

The customer enquiry system did not include the functionality to publish quarterly data for 2015–16.

PERFORMANCE INDICATOR: Feedback mechanisms are in place and used to improve service delivery to regulated entities
Metric Results RPF reference

Demonstrated process to collect stakeholder feedback

An online feedback mechanism is in place to enable users to report problems, suggest improvements, lodge complaints and provide feedback via the APVMA website

5.2.A

100% of feedback received through the online feedback system is assessed within five working days

Feedback is monitored and assessed daily and referred for action as required

5.2.B

Source: APVMA corporate plan 2015–19, APVMA operational plan 2015–16 and APVMA regulator performance framework 2015–16

Enhancing the regulatory system

PERFORMANCE INDICATOR: Feedback is provided to inform the development or amendment of regulatory frameworks
Metric Results RPF reference

Documented procedures in place to facilitate engagement with the Department of Agriculture and Water Resources and relevant state and territory agencies

The APVMA and the Department of Agriculture and Water Resources meet monthly to discuss ongoing operational matters and proposed reforms

The APVMA attended three reform sessions with industry hosted by the department in Canberra, Sydney and Melbourne

The APVMA has regular contact with state and territory coordinators for registration, permit issue and chemical review activities

We held two face-to-face workshops with relevant state and territory agencies regarding chemical review prioritisation and ongoing operational matters

The APVMA hosted a forum for state and territory coordinators to discuss regulatory approaches

6.2.A

Source: APVMA corporate plan 2015–19APVMA operational plan 2015–16 and APVMA regulator performance framework 2015–16

PERFORMANCE INDICATOR: Level of stakeholder engagement in implementing regulatory frameworks
Metric Results RPF reference

Documented stakeholder consultation procedures in place

Documented procedures for consultation on the registration or reconsideration of or amendments to active constituents, chemical products, MRLs and Standards are in place

6.1.A

100% of significant changes to APVMA regulatory frameworks involve stakeholder consultation

There were no significant changes to APVMA regulatory frameworks in 2015–16

6.1.B

Source: APVMA corporate plan 2015–19APVMA operational plan 2015–16 and APVMA regulator performance framework 2015–16

Regulatory science

One of the keys to APVMA's success lies in the calibre of its regulatory scientists. The APVMA has a strong focus on improving its regulatory science capability.

PERFORMANCE INDICATOR: Improvements in regulatory science capability are consistent with agreed priorities and strategies
Metric Results RPF reference

Documented science strategy

The APVMA science strategy is available under 'Corporate documents'

NA

Regulatory science activities are aligned with relevant activities of similar regulators

The APVMA aligned its activities with other regulators by:

  • participating in the Australian Regulatory Science Network (RSN), and relevant working groups and committees
  • engaging with international regulatory authorities and participating in global harmonisation activities of expert advisory bodies, including the OECD and VICH

NA

Regulatory science communication to external stakeholders improved by provision of targeted web-based information

Science pages on the APVMA website enable information sharing, awareness raising, and greater transparency—building confidence in the quality of our science and our scientists. See 'Our science'

NA

Three staff seminars completed on regulatory science issues, including risk assessment methodologies and new technologies

Staff seminars included:

  • a training session on veterinary therapies for the treatment of mastitis
  • a roundtable on bioequivalence, held with Professor Jim E Riviere, Director at the Institute of Computational Comparative Medicine, Purdue University, USA
  • a symposium held with the CSIRO on the use of gene drive technology in controlling pests and diseases
  • a neonicotinoids and pollinators seminar

NA

Regulatory science projects undertaken according to agreed timeframes

Regulatory science projects undertaken in agreed timeframes in 2015–16 included:

  • public consultations on:
    • aquatic exposure modelling
    • dryland cropping component
    • bee risk assessment guidance
  • completion of both risk profiling of imported live micro-organisms for use in veterinary vaccines, and pharmaceutical equivalence
  • the scoping approaches for assessing fumigants was stopped due to competing priorities
  • more information is in Appendix A, page 94

NA

Source: APVMA corporate plan 2015–19APVMA operational plan 2015–16

High-performing organisation

The APVMA is staffed by a team of highly qualified people, all focused on ensuring agvet chemicals are safe to use. Ensuring that our workforce is motivated and trained and that our systems can underpin an efficient and effective business is a high priority.

PERFORMANCE INDICATOR: Motivated and trained workforce
Metric Results RPF reference

Absenteeism rate at or below Australian Public Service (APS) average

The APVMA unscheduled absence 
rate was 13.2 days per full-time employee, which was above the 
APS average of 11.6

NA

Adherence to the code of conduct

Following investigation and determination, one APVMA staff member was found to have breached the APS Code of Conduct in the 2015–16 financial year

NA

Number of corporate training days per full-time equivalent (FTE)

During the 2015–16 financial year, staff participation in training averaged 5.1 training days per FTE

NA

80% of recruitment processes completed within 45 days

35% achieved

A total of 46 recruitment processes were completed in 2015–16

NA

Ensure our people have the skills to do their job

The Training Advisory Group, comprising representatives across all program areas, was established to identify and discuss learning and development needs for staff.

Training has been delivered on a range of topics, including scientific analysis, use of spreadsheets, legal administration, leadership and management principles

NA

Source: APVMA corporate plan 2015–19APVMA operational plan 2015–16

Absenteeism rate

Absenteeism was higher during 2015–16 than previous years, which was largely due to long-term non-compensable absences affecting a small number of APVMA staff. These absences were actively managed and support was provided to affected staff.

Recruitment activities

Recruitment activities were higher during 2015–16 year than previous years. Delays were experienced in progressing and finalising a number of processes for a range of reasons, such as selection panel member availability and candidate availability.

PERFORMANCE INDICATOR: Efficient and effective business processes and financial management systems in place
Metric Results RPF Reference

No significant findings from internal and external audits

Six internal audits were conducted during the year

No findings from these audits were considered significant by internal auditors or the audit committee

An external audit of the 2015–16 financial statements did not result in any findings deemed significant by the auditors or the audit committee

NA

Audited financial statements cleared by due date

The audited financial statements were cleared and lodged with the Department of Finance by the due date of 31 August 2016

NA

Sound budget management

Total expenditure for 2015–16 was within 3% of the initial budget published in the Portfolio Budget Statements

Statement of comprehensive income

No preventable health and safety incidents requiring notification to the regulator, Comcare

No incidents requiring notification to Comcare arose during the reporting period

NA

Equity reserve targets managed

The APVMA's equity level at 30 June 2016 was $7.3 million, which is above the target of $7.0 million

NA

Comply with government reporting requirements, legislation and standards

All government reporting requirements were complied with

NA

Source: APVMA corporate plan 2015–19APVMA operational plan 2015–16

PERFORMANCE INDICATOR: Protect and manage information and enhance information technology to improve service delivery and staff capability
Metric Results RPF reference

Maintain IT system uptime to 97% or greater

98.6% system uptime with:

  • one high-severity incident 
    (24 hours downtime)
  • <10 minor outages 
    (<2 hours downtime)

NA

No significant security incidents

No significant security incidents occurred

NA

Cyber intrusions defeated before damage occurs

The APVMA receives an average of 70 cyber intrusion attempts per month

100% of cyber intrusion attempts were defeated before damage occurred

NA

Virus attacks defeated before damage occurs

The APVMA blocks an average of 300 000 malicious email messages per month

On average, 500 of these are identified as virus attacks

100% of virus attacks were defeated before damage occurred

NA

Source: APVMA corporate plan 2015–19APVMA operational plan 2015–16

N/A – no applications were received for that item in the reporting period.

* Some items have a variable legislated assessment period because they are modular in nature. Each individual 
application will have a different expected duration. The figure in brackets after the variable text shows the average expected timeframe for these items in this reporting period. This average expected timeframe may change each reporting period, depending on the nature of the applications evaluated by the APVMA.

 

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