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Annual Report 2016–17—Chapter 3: Annual performance
1. Strategic framework and reporting
Four strategies outlined in the APVMA Corporate plan 2015–20 and Operational plan 2016–17 have helped the agency to achieve its purpose and objectives (Figure?2):
- Strategy 1—Decision making:?Deliver regulatory decisions that are timely, science-based and proportionate to the risks being managed
- Strategy 2—Regulatory burden:?Reduce the burden on industry in complying with?regulatory requirements
- Strategy 3—Client focus:?Build a client-focused approach to service delivery, committed to continuous improvement
- Strategy 4—High performance and efficiency:?Operate as a contemporary, high-performing and efficient organisation.
1.1. our strategies
Our purpose is underpinned by four strategies
Figure?2:?APVMA strategies
1.2. Statement of preparation by the Chief Executive Officer
I, as the accountable authority of the APVMA, present the 2016–17 annual performance statement of the APVMA, as required under paragraph?s39(1)(a) of the Public Governance, Performance and Accountability Act 2013 (PGPA Act). In my opinion, these annual performance statements are based on properly maintained records, accurately reflect the?performance of the entity and comply with subsection?39(2) of the PGPA Act.
Dr Chris Parker
Chief Executive Officer
29 September 2017
1.3. Results against performance criteria
This chapter provides the results of our performance against:
- three performance criteria listed in the?APVMA Portfolio Budget Statement (PBS)
- 22 performance criteria listed in the APVMA Corporate plan 2015–20 (including the three PBS criteria).
Each performance criterion has one or more metrics, as outlined in the APVMA Operational plan 2016–17. Results at the metric level are presented in tables, with one table for each performance strategy. A summary and explanation of the performance against the strategy is provided at the beginning of each strategy section.
1.4. Variation from the APVMA Portfolio Budget Statement
There have been no variations from the PBS in 2016–17.
“We have achieved our statutory
2. Strategy 1—Decision making
Deliver regulatory decisions that are timely, science-based and proportionate to the risks being managed
2.1. Summary of performance
APVMA regulatory decisions are based on robust, risk-based scientific evaluations. To?achieve this, we aim to:
- complete regulatory decisions within specified timeframes
- undertake, in a timely manner, regulatory responsibilities to register products, approve activities, license veterinary manufacturers, review chemicals and ensure compliance in the marketplace
- undertake actions proportionate to the regulated risk being managed
- improve the quality and consistency of our regulatory decision making through the?use?of committees (registration quality, science quality and enforcement)
- use regulatory science to underpin quality regulatory decision making
- deliver and implement regulatory science projects.
Table?2 provides a summary of activities related to regulatory decisions this year. We have achieved our statutory responsibilities in terms of compliance, enforcement and reviews and achieved close to our target in terms of audits; but achieved below our target in terms of timeframes for completion of applications.
Table 2:?Activities related to APVMA regulatory decisions, 2016–17
Types of regulatory decisions | Commenced | Finalised/ issued | In progress |
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Pre-application assistance | 139 | 139 | 34 |
Product registration—pesticides | 1 013 | 750 | 673 |
Product registration— veterinary medicines | 654 | 596 | 389 |
Actives | 738 | 648 | 370 |
Permits | 505 | 459 | 226 |
Items 8L, 8M, 8P | 267 | 282 | 17 |
Item 25 | 15 | 16 | 14 |
Notifiable variations | 995 | 967 | 53 |
Import consents | 803 | 788 | 6 |
Certificates of export | 343 | 335 | 19 |
2.2. Explanation of performance
The APVMA is a mature organisation with sound processes that have been developed and tested over many years, including compliance and enforcement approaches and risk management strategies. These processes support our core business of delivering timely science-based regulatory decisions.
Although there were some delays in audits because of logistical issues, 84?per cent of audits were completed as per the schedule and auditing quality was not affected. There was a reduction in the timeframe and completion performance for product applications in the second half of the year. These results were influenced by a high turnover of staff in Registration Management and Evaluation and initial delays in recruiting and training suitable skilled staff.
Table 3 provides a summary of our progress of regulatory decisions within timeframes under Strategy 1.
Table 3:?Strategy 1—Decision-making results
Key activity: Complete regulatory decisions within timeframes | ||
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Performance measure | Source | Result against performance measure |
Percentage of applications completed within timeframes |
Corporate plan 2015-20 | This year, the APVMA:
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Table 4:?Applications processed by the APVMA, 2016–17
Application type | Started | Finalised | Finalised within timeframe |
In progress | |
---|---|---|---|---|---|
Products | Pesticides | 1013 | 750 | 45% | 673 |
? | Veterinary medicines | 654 | 596 | 77% | 389 |
? | Subtotal | 1667 | 1346 | 59% | 1062 |
Actives | ? | 738 | 648 | 88% | 370 |
Permits | ? | 505 | 459 | 71% | 226 |
Total | ? | 2910 | 2453 | 69% | 1658 |
Percentage of compliance and enforcement activities completed within timeframes |
Corporate plan 2015–20 |
The agvet legislative framework has no timeframes for compliance and monitoring actions; we aim to complete cases in the shortest time possible. This?year, the Compliance and Monitoring section:?
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Key activity: Undertake, in a timely manner, regulatory responsibilities to register products, approve activities, license veterinary manufacturers, review chemicals and ensure compliance in the marketplace | ||||||||||||||||||||||||||||||||||||||||||
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Performance measure | Source | Result against performance measure | ||||||||||||||||||||||||||||||||||||||||
100% of statutory notices issued by Compliance are gazetted in accordance with legislative requirements |
Operational plan 2016–17 |
Under the Agvet Code, if the APVMA issues a statutory recall notice we must publish a notice in?the APVMA Gazette within 14?days. This year:
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Good manufacturing practice (GMP) audit program implemented as per APVMA schedule |
Operational plan 2016–17 |
The APVMA conducts GMP audits of Australian and overseas manufacturing facilities to confirm that manufacturing facilities of veterinary chemical products comply with the APVMA’s Manufacturing Principles and the Australian Code of GMP for Veterinary Chemical Products. This year, 86% of audits were carried out on schedule (Table?5). Delays were attributed to timing and availability of auditors (eg?the due date falling on a public holiday or auditor unavailability), 93% of audits were completed within one week of the due date. Table 5: APVMA GMP audits, 2016–17
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No applications to be overdue by more than three months from 1?January 2017 |
Operational plan 2016–17 |
There were 193?applications overdue by more than?three months on 1?January 2017. | ||||||||||||||||||||||||||||||||||||||||
Reduce the duration of applications and average decision time by item |
Operational plan 2016–17 |
The APVMA assesses applications against 26?item numbers across several categories. The?average decision time for applications (Table?6) is:
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Table 6:?Applications and time to finalisation, 2016–17
? | ? | Standard applications (months) | Extended applications (months) | ||||
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Type of application | Item | Number finalised | Actual average duration | Legislated assessment period | Number finalised | Actual average duration | Legislated assessment period |
New product (new active) | 1 | 7 | 35.4 | 18.0 | N/A | N/A | 25.0 |
? | 2 | 17 | 29.6 | Variable (14.4*) | 23 | 23.1 | Variable (19.2*) |
New product (existing active) | 3 | 0 | 0.0 | 18.0 | 1 | 27.1 | 25.0 |
? | 4 | N/A | N/A | 18.0 | N/A | N/A | 25.0 |
? | 5 | 13 | 11.5 | 8.0 | 10 | 13.7 | 12.0 |
? | 6 | 10 | 20.1 | 8.0 | 17 | 16.6 | 12.0 |
? | 7 | 125 | 4.5 | 3.0 | 36 | 8.0 | 5.0 |
? | 8 | 118 | 3.3 | 3.0 | 29 | 5.2 | 5.0 |
? | 9 | 1 | 1.7 | 2.0 | 1 | 4.0 | 4.0 |
? | 10 | 97 | 11.1 | Variable (7.6*) | 103 | 14.4 | Variable (12.8*) |
? | 10A | 32 | 2.0 | Variable (2.0*) | 1 | 6.4 | Variable (3.9*) |
Product variations | 11 | N/A | N/A | 10.0 | N/A | N/A | 15.0 |
? | 12 | 198 | 3.6 | 3.0 | 14 | 6.3 | 5.0 |
? | 13 | 10 | 2.2 | 3.0 | N/A | N/A | 5.0 |
? | 13A | 220 | 0.7 | 1.0 | N/A | N/A | N/A |
? | 14 | 141 | 8.2 | Variable (6.7*) | 111 | 9.5 | Variable (10.1*) |
Actives | 15 | 3 | 33.9 | 14.0 | 1 | 21.7 | 20.0 |
? | 16 | 2 | 16.2 | 9.0 | N/A | N/A | 13.0 |
? | 17 | 488 | 3.8 | 7.0 | 57 | 7.6 | 11.0 |
? | 18 | 86 | 5.5 | 7.0 | 9 | 9.6 | 11.0 |
Permits | 19 | 10 | 2.0 | 3.0 | 1 | 3.4 | 5.0 |
? | 20 | 173 | 5.5 | 7.0 | 9 | 9.6 | 11.0 |
? | 21 | 103 | 6.9 | Variable (4.9*) | 17 | 9.7 | Variable (10.5*) |
? | 22 | 57 | 1.0 | Variable (4.0*) | 5 | 4.7 | Variable (10.2*) |
? | 23 | 70 | 3.4 | 3.8 | 13 | 8.6 | 9.4 |
? | 112a | 5 | 0.6 | Variable (0*) | N/A | N/A | N/A |
N/A = no applications were finalised for that item in the reporting period
*Some items have variable legislated assessment periods because they are modular. Each application will have?a different expected duration. The figure in brackets after ‘Variable’ shows the average expected timeframe for these items. The average expected timeframe may change each reporting period, depending on?the nature of applications.
Key activity: Undertake actions proportionate to the regulated risk being managed | ||
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Performance measure | Source | Result against performance measure |
Risk management frameworks and policies are in place and regularly assessed |
Corporate plan 2015–20 |
Policies are in place and regularly assessed.
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Lower regulatory effort is applied to activities of lower regulatory risk |
Corporate plan 2015–20 |
In September 2016, the APVMA expanded the list of notifiable variations—minor changes to active constituents, products and labels that are accepted by a simpler and faster process of?notification, rather than an application—as an outcome of the lower regulatory approaches to registration project. Five new items were added to?the list. The APVMA will continue to look for other application types that may be suitable to be?a notifiable variation.?
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Compliance and enforcement strategies are consistent with agreed risk management |
Corporate plan 2015–20 |
The APVMA has a publicly available Compliance and enforcement strategy 2015–17 that has three central compliance and enforcement approaches: education, engagement and enforcement.
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Key activity: Improve the quality and consistency of our regulatory decision making through the use of committees (registration quality, science quality and enforcement) | ||
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Performance measure | Source | Result against performance measure |
Number of internal? reviews and Administrative Appeals Tribunal (AAT) applications that result in reversal of decision |
Operational plan 2016–17 |
This year, five internal reviews reversed an earlier decision. Four of the matters were instances where applications had been lodged with the AAT but by consent were remitted to the APVMA for reconsideration following a Federal Court decision. |
Key activity: Use regulatory science to underpin quality regulatory decision making | ||
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Performance measure | Source | Result against performance measure |
Improvements in regulatory science capability are consistent with agreed priorities and?strategies |
Corporate plan 2015–20 |
We liaised with industry experts specialising in nanotechnology and biotechnology, and will continue to do so to anticipate future regulatory challenges and required management approaches |
Key activity: Deliver and implement regulatory science projects | ||
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Performance measure | Source | Result against performance measure |
Project milestones are met | Operational plan 2016–17 |
This year, we:
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Timeframes for chemical reviews are?met and work plans published |
Operational plan 2016–17 |
This year, we:
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3. Strategy 2—Regulatory burden
Reduce the burden on industry in complying with regulatory requirements
3.1. Summary of performance
It is important that our regulatory processes support industry operations. To that end, they?need to be easy to navigate and use, and should enable the APVMA to work as efficiently and quickly as possible. To achieve this, we aim to:
- remove unnecessary impediments to the efficient operation of regulated entities
- develop an online ‘fast-tracked’ registration system for applications requiring lower?levels of regulatory intervention
- develop at least four standards for lower regulatory risk product types
- increase the use of assessments from comparable regulators in decision making
- align technical guidelines and guidance material with international requirements, unless there is a justifiable reason not to
- seek efficiencies in conducting assessments through more contestability
- streamline and coordinate compliance and monitoring approaches
- ensure compliance and licensing activities are consistent with regulatory risk
- define crop groups and provide associated guidance material to streamline the registration process.
The 2016–17 federal budget included $7.3?million over four?years to implement the?APVMA’s components of the Agricultural Competitiveness White Paper reforms. This?work?focuses on investigating and implementing lower regulatory approaches for?all?applications for active constituent approvals, product registrations and variations. Supported by the white paper funding, the APVMA has developed a plan to introduce more?efficient pathways for registration during the next two?years. The activities outlined?under this strategy fall within the scope of this plan.
This year, we developed a number of new approaches that aim to reduce the burden on industry in meeting regulatory requirements when an application is submitted and?assessed.
We have developed guidance for industry about the use of international data and standards in applications, and are reworking our data guidelines to better align with the?international material. We are also starting to define the supports required for a fully?modular assessment system for applications. In coming years, further use of this system will enable us to use international or third-party assessments and to tailor assessments and regulatory treatment to individual applications.
We launched a pilot project enabling applicants to obtain efficacy assessments before submitting an application, and are working on projects to improve access to chemical products for use on minor crops by?streamlining registration requirements and to determine which permits are suitable for?conversion to full registration.
We have put into place a fast-track system for low-risk applications that will help streamline regulatory assessment and product registration. This system has been well received and is already reducing administrative burdens and accelerating registration for eligible products. In addition, we are consulting with industry about the use of listed standards to define the conditions under which a group of products can be fast-tracked.
In relation to enforcement and monitoring, the APVMA assesses 100?per cent of noncompliance allegations on time. Most allegations (83?per cent) were assessed as low risk and were resolved through education and negotiated compliance. We continued proactive monitoring and engagement with external law enforcement and regulatory bodies.
3.2. Explanation of performance
The APVMA is learning from international best practice in developing a fast-track system to?better meet industry and stakeholder needs. This has made good progress this year.
Table 7:?Strategy 2—Regulatory burden results
Key activity: Remove unnecessary impediments to the efficient operation of regulated entities | ||
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Performance measure | Source | Result against performance measure |
Demonstrated understanding of the?operating environment for the regulated entities |
Corporate plan 2015–20 |
This year, we:?
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International data guidelines, standards and assessments adopted to reduce effort to register agvet?chemicals |
Corporate plan 2015–20 |
The APVMA has developed guidance for industry on international data, standards and assessments, including Organisation for Economic Co-operation and Development guidelines, standards and assessments. In March 2017, we published the Guidance for applicants – submission of international data, standards and assessment. ? See also Key activity: Align technical guidelines and guidance material with international requirements, unless there is a justifiable reason not to. |
Efficient and effective APVMA business processes |
Corporate plan 2015–20 |
This year, we finalised the semiautomated decision document template (November 2016) and used the template for all new applications. |
Key activity: Develop an online ‘fast-tracked’ registration system for applications requiring lower levels of regulatory intervention | ||
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Performance measure | Source | Result against performance measure |
Achieve key project? milestones |
Operational? plan 2016–17 |
From July to December 2016, the APVMA piloted a fast-track registration pathway for companies wanting to repack their own products; this is still available to applicants. The pilot:
As at 30?June 2017:
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Key activity: Develop at least four standards for lower regulatory risk product types | ||
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Performance measure | Source | Result against performance measure |
Complete standards for dairy sanitisers, swimming pool products, antifouling paints and household insecticides |
Operational plan 2016–17 |
Listed standards define the conditions under which the APVMA is satisfied about a particular group of products. Products that meet the standard could achieve fast-track registration. This year:
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Key activity: Increase the use of assessments from comparable regulators in decision making | ||
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Performance measure | Source | Result against performance measure |
Number of applications using data assessments, standards and decisions from comparable regulators |
Operational plan 2016–17 |
Data submitted for major applications that have been considered by comparable regulators are commonly ubmitted and used by the APVMA in assessments. The APVMA continues to reference international standards, including pharmacopoeial standards from the?Food and Agriculture Organization?of the United Nations (FAO), Europe, Britain and the United States of America. ? This year:
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Key activity: Align technical guidelines and guidance material with international requirements, unless there is a justifiable reason not to | ||
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Performance measure | Source | Result against performance measure |
International data guidelines, standards and assessments adopted to reduce effort to register agvet?chemicals |
Operational? plan 2016–17? Regulator? Performance Framework |
The APVMA has adopted international technical guidance material and advanced the rework of data guidelines to better align with the international material. This?work involved:
We provided guidance to our staff on how to handle international assessments and industry can now submit international assessments in support of registration applications. |
Key activity: Seek efficiencies in conducting assessments through more contestability | ||
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Performance measure | Source | Result against performance measure |
Efficacy contestability pilot milestones are?met |
Operational plan 2016–17 |
This year:
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Proportion of? assessments done by external scientific reviewers |
Operational plan 2016–17 |
This year, the majority of efficacy assessments, 57% of environment and 30% of human health, were ndertaken by private sector reviewers. The Australian Government Department of the Environment and Energy undertook 12% of environment assessments completed this year. |
Key activity: Streamline and coordinate compliance and monitoring approaches | ||
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Performance measure | Source | Result against performance measure |
Monitoring and enforcement strategies allow for?a?range of regulatory responses |
Corporate plan 2015–20 |
The Compliance and enforcement strategy 2015–17 sets out a risk-based approach to dealing with matters of noncompliance in a proportionate and efficient manner. The Compliance and Monitoring section assesses and prioritises allegations of noncompliance within five working days. This year:
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Compliance activities are responsive to business needs of regulated entities, where relevant |
Corporate plan 2015–20 |
This year, the Compliance and Monitoring section:
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Information requested from regulated entities is necessary and acted upon |
Corporate plan 2015–20 |
For each matter of noncompliance, the Compliance and Monitoring section sent an average of three nformation requests. The information requested helps us to assess the validity and scale of the noncompliance and, in most cases, is provided voluntarily by the organisation concerned. In most cases, information exchanges result in a negotiated compliant outcome. This year, we:
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Key activity: Ensure compliance and licensing activities are consistent with regulatory risk | ||
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Performance measure | Source | Result against performance measure |
Risk management frameworks and policies are in place and regularly reassessed |
Operational? plan 2016–17? Regulator? Performance Framework |
The Manufacturing Quality and Licensing section conducts audits and licenses manufacturers using a risk-based model. In?these:
This year, we commenced a review of our new audit scheduling model to ensure that the agency manages licensing risks effectively. Data to inform a review of the strategy were collated and will be analysed in 2017–18. The Compliance and enforcement strategy 2015–17?is reviewed every three years and will be reviewed in 2017–18. |
Lower regulatory effort?is applied to activities of lower regulatory risk |
Operational? plan 2016–17? Regulator? Performance Framework |
Low-risk cases are those that have a small number of products involved and that demonstrate a limited risk to human health, animals, the environment and trade. For such cases, education is our main compliance response. Education informs the?noncompliant organisations of their regulatory responsibilities and helps to establish a pathway to future compliance. This year, 83%?of the APVMA’s 199?compliance cases were rated as low risk. See also Key activity: Undertake actions proportionate to the regulated risk being managed, Key activity: Develop an online ‘fast?tracked’ registration system for applications requiring lower levels of regulatory intervention and Key activity: Develop at least?four standards for lower regulatory risk?product types. |
Monitoring and enforcement strategies allow for?a?range of regulatory responses |
Corporate plan? 2015–20? Regulator? Performance Framework |
This year:
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Compliance activities are responsive to business needs of regulated entities, where relevant |
Corporate plan? 2015–20? Regulator? Performance Framework |
This year:
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Information requested?from regulated entities is?necessary and acted upon |
Corporate plan? 2015–20? Regulator? Performance Framework |
The APVMA may request information related to an application for a licence or a variation to?a licence. Information is:
See also Key activity: Streamline and coordinate compliance and monitoring approaches. |
Key activity: Define crop groups and provide associated guidance material to streamline the registration process | ||
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Performance measure | Source | Result against performance measure |
Achieve key? milestones |
Corporate plan? 2015–20 |
The APVMA is working on a project to improve access to chemical products for use on minor crops by streamlining registration requirements (in collaboration with the Department of Agriculture and Water Resources). This year: Phase 1 was completed with an official Australian crop groups list published that includes the individual crops in these groups work commenced on Phase 2 to identify representative crops from each group that can be used to generate acceptable data for safety, efficacy and trade criteria; a final listing of crop groups, representative crops and guidance material will be published in 2017–18. |
4. Strategy 3—Client focus
Build a client-focused approach to service delivery,
committed to continuous?improvement
4.1. Summary of performance
The APVMA works with a range of stakeholders and it is important that our information and communication facilitates stakeholder actions and interactions. To achieve this, we?aim to:
- ensure communication with regulated entities is clear, targeted and effective
- develop a clear understanding of applicant needs and wants about the registration process
- review communication with applicants about how to make a registration application and navigate the registration system and maintain tracking of progress
- improve the quality and quantity of guidance information for applicants
- ensure active contribution to the continuous improvement of regulatory frameworks
- monitor and act on trends in client feedback
- ensure openness and transparency in dealings with regulated entities
- provide clear information about agency performance.
This year, we worked on a range of projects to obtain a clear understanding of what applicants want from the APVMA, to explain more clearly how to make a registration application and navigate the application system, and to improve our communication and?technical guidance material.
We completed a review of our online channels and information, and of outgoing letters, notices and emails. Opportunities for short-, medium- and long-term improvements have been identified and work is underway to implement these. We have made initial changes to the website, and a subsequent review found that user searches and discoverability of guidance material has improved. We implemented newsletter, notice and email templates; initial data on the rate and nature of client responses indicate user comprehension has?improved.
We published the Guide to completing an online application and Guidance for submission of international data standards and assessments, and a project to improve other guidance material for most product applications has commenced including conducting industry workshops. We continue to collect voluntary feedback about the pre-application assistance (PAA) process, and this year 100?per cent of applicants agreed that the information and guidance material for this?process was clear.
We consulted publicly on 45?regulatory decisions and proposed changes to operational policy and development of guidelines. We received at least 7100?calls and 8800?emails about applications, and have implemented a case manager model for enquiries which has improved the continuity of handling. Subscriptions to the APVMA Gazette continue to?increase.
4.2. Explanation of performance
The review of our information and communication showed that improvement can be made in many areas. We are therefore working to systematically improve our online offerings and our interactions with stakeholders. Feedback to date on these improvements is encouraging.
We received increased media enquiries and interest in the management and performance of our business following the relocation announcement.
Table 8:?Strategy 3—Client focus results
Key activity: Ensure communication with regulated entities is clear, targeted and effective | ||
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Performance measure | Source | Result against performance measure |
Level of satisfaction with information and guidance materials |
Corporate plan? 2015–20 |
Feedback from stakeholders confirms that APVMA information and guidance material can be improved and we are working on a range of projects to bridge the gap between client expectations and experiences. This year:
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Level of satisfaction? with the quality and timeliness of advice on?decisions |
Corporate plan? 2015–20 |
This year:
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Extent and satisfaction with APVMA consultative processes |
Corporate plan? 2015–20 |
The APVMA consults on all major changes to operational policy and guidelines before finalisation. This year:
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Key activity: Develop a clear understanding of applicant needs and wants about the registration process | ||
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Performance measure | Source | Result against performance measure |
Achieve key project? milestones |
Operational? plan 2016–17 |
The website usability review informed activities that have progressed in 2016–17 and are expected to be completed by June 2018, including:
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Demonstrated understanding of the operating environment of the regulated entities |
Operational plan 2016–17 Regulator Performance Framework |
A two-day industry information and engagement event was held in Canberra during November 2016. Of the attendees, including 180?stakeholders, 95.95% either strongly agreed or agreed that the session was a useful and worthwhile forum for consultation. The event allowed stakeholders to engage?in two-way feedback, and provided a forum for the APVMA to listen to challenges and opportunities impacting the?regulated?industry. |
Extent and satisfaction with APVMA consultative processes |
Operational plan 2016–17 Regulator Performance Framework |
See Key activity: Ensure communication with regulated entities is clear, targeted and?effective |
Level of stakeholder engagement in implementing regulatory?frameworks |
Operational plan 2016–17 Regulator Performance Framework |
We continue to engage stakeholders in the?planning of APVMA business improvement projects. In February 2017, we held workshops to establish client expectations for improved regulatory guidance and delivery of fast-tracked registration. From 2017–18, stakeholders will be engaged in a series of Agricultural Competitiveness White Paper and business improvement activities that are?designed to increase user satisfaction with regulatory guidance materials. |
Satisfaction with APVMA online systems for submitting and managing applications |
Operational plan 2016–17 Regulator Performance Framework |
Several features aimed at streamlining applications have been added to APVMA online systems this year. See Key activity: Develop an online ‘fast?tracked’ registration system for applications requiring lower levels of regulatory intervention, and Key activity: Ensure communication with regulated entities is clear, targeted and effective. |
Customer services standards met |
Operational plan 2016–17 Regulator Performance Framework |
This year:
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Key activity: Review communication with applicants about how to make a registration application and navigate the registration system and maintain tracking of progress | ||
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Performance measure | Source | Result against performance measure |
Level of satisfaction? with information and guidance materials |
Operational plan 2016–17 Regulator Performance Framework |
This project is expected to be completed by June 2018. In 2016–17, project plans were developed and endorsed that will improve guidance material for the majority of product applications. |
Feedback about the quality of pre-application assistance (PAA) |
Operational plan 2016–17 Regulator Performance Framework |
We continue to collect voluntary feedback about different aspects of the PAA process. This year we received 12?submissions, and:
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Key activity: : Improve the quality and quantity of guidance information for applicants | ||
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Performance measure | Source | Result against performance measure |
100% of correspondence provided to applicants/ registrants assessed as comprehensive and?easily understood |
Operational plan 2016–17 Regulator Performance Framework |
A correspondence improvement project began in 2015–16 with a full audit of all outgoing letters, notices and emails. Feedback has identified priority products for action and we commenced work in 2016–17 to improve correspondence products. This year, we implemented newsletter, notice and email templates; initial data on the rate and nature of client responses indicate improvements in user?comprehension. |
Key activity: Ensure active contribution to the continuous improvement of regulatory frameworks | ||
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Performance measure | Source | Result against performance measure |
Level of stakeholder engagement in implementing regulatory?frameworks |
Corporate plan 2015–20 |
See Key activity: Develop a clear understanding of applicant needs and wants?about the registration process. |
Feedback is provided to inform the development or amendment of regulatory frameworks |
Corporate plan 2015–20 |
See Key activity: Ensure communication with regulated entities is clear, targeted and?effective. |
Key activity: Monitor and act on trends in client feedback | ||
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Performance measure | Source | Result against performance measure |
Feedback mechanisms are in place and used to improve services to?regulated entities |
Operational plan 2016–17 Regulator Performance Framework |
See Key activity: Ensure communication with regulated entities is clear, targeted and?effective and Key activity: Develop a clear understanding of applicant needs and?wants about the registration process. |
Documented procedures in place to facilitate engagement with the Department of?Agriculture and Water?Resources and relevant state and territory agencies |
Operational plan 2016–17 Regulator Performance Framework |
This was completed in 2017 and engagement is being undertaken in line?with these procedures. |
Key activity: Ensure openness and transparency in dealings with regulated entities | ||
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Performance measure | Source | Result against performance measure |
Performance information is published |
Corporate plan 2015–20 |
APVMA Operational Performance reports are produced quarterly and are published on the website within six?weeks of the end of the quarter. The APVMA annual report is produced according to government guidelines and the 2015–16 report was delivered on time. |
Feedback mechanisms are in place and used to improve service delivery to regulated entities |
Corporate plan? 2015–20 |
See Key activity: Ensure communication with regulated entities is clear, targeted and?effective and Key activity: Develop a clear understanding of applicant needs and wants about the registration process |
Key activity: Ensure openness and transparency in dealings with regulated entities | ||
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Performance measure | Source | Result against performance measure |
Performance information is published |
Operational plan 2016–17 Regulator Performance Framework |
See Key activity: Ensure openness and transparency in dealings with regulated entities. |
5. Strategy 4—High performance and efficiency
Operate as a contemporary, high-performing and efficient organisation
5.1. Summary of performance
Developing and maintaining efficient and effective business systems and resources are essential to our organisation. To achieve this, we aim to:
- ensure a high level of organisational health and financial viability
- provide clear work instructions and management controls
- ensure business systems support the efficient operation of the agency
- streamline the end-to-end registration process in line with the project plan deliverables
- complete the review of the good manufacturing practice (GMP) assessment programs
- implement the IT Strategic Plan to support information management, staff capability and service delivery
- develop our digital strategy and capability
- implement recommendations from the Protective Security Policy Framework (PSPF) review
- ensure organisational sustainability
- implement the APVMA people strategy
- closely manage the APVMA budget
- implement the learning and development strategy.
This year, we have focused on two key areas: staffing and IT.
We have recruited and inducted a high number of staff, and focused training on technical and scientific processes. We are focused on programs and initiatives to support our staff
We have continued to develop and improve our IT systems to support efficient submission and processing of agvet applications, including an upgrade of the EDRMS; implementation of an internal instructional material library for the proactive management of APVMA policies, processes and procedures; and the migration and decommissioning of legacy business systems. We developed the ICT strategic plan 2016–19, and started to develop an APVMA Digital strategy to enable the operation of the APVMA from Armidale.
5.2. Explanation of performance
This year we have experienced a higher-than-anticipated staff separation rate. We continue to review our human resource capabilities to make sure staff have the right skills to deal with challenges that face the APVMA. We are continuing to focus on reviewing and redesigning our strategies around recruitment, retention, knowledge management and building our scientific capability.
Table 9:?Strategy 4—High performance and efficiency results
Key activity: Ensure a high level of organisational health and financial viability | ||
---|---|---|
Performance measure | Source | Result against performance measure |
APVMA workforce is? motivated and skilled |
Corporate plan? 2015–20 |
This year:
|
Efficient and effective business processes and financial management systems?in place |
Corporate plan? 2015–20 |
This year, we:
|
Information technology supports information management, staff capability and service?delivery |
Corporate plan? 2015–20 |
The APVMA has online systems to support information management, staff capability and service delivery, including:
This year, several initiatives were completed to improve service delivery in?these areas, including:
|
Key activity: Provide clear work instructions and management controls | ||
---|---|---|
Performance measure | Source | Result against performance measure |
Review internal work instructions within scheduled timeframes |
Operational plan 2016–17 |
This year:
|
Key activity: Ensure business systems support the efficient operation of the agency | ||
---|---|---|
Performance measure | Source | Result against performance measure |
Reduction in number of legacy business systems |
Operational plan 2016–17 |
We are conducting a project to migrate and?decommission legacy business systems by October 2018. This year:
|
Key activity: Streamline the end-to-end registration process in line with the project plan deliverables | ||
---|---|---|
Performance measure | Source | Result against performance measure |
Achieve key? project?milestones |
Operational plan 2016–17 |
This year:
|
Key activity: : Complete the review of the good manufacturing practice (GMP) assessment programs | ||
---|---|---|
Performance measure | Source | Result against performance measure |
Review completed | Operational plan 2016–17 |
|
Key activity: Implement the IT Strategic Plan to support information management, staff capability and service delivery | ||
---|---|---|
Performance measure | Source | Result against performance measure |
Review completed | Operational plan 2016–17 |
This year, the ICT strategic plan 2016–19 was finalised and endorsed by the CEO and Executive Leadership Team. This plan included:
|
IT Strategic Plan milestones are met |
Operational plan 2016–17 |
Initiatives from the ICT strategic plan 2016–19 and the Information management strategic plan 2016–20 are now underway, with quarterly traffic light reports to be presented to the executive team from 2017–18. |
Key activity: Develop our digital strategy and capability | ||
---|---|---|
Performance measure | Source | Result against performance measure |
Provide information systems that support the business |
Operational plan 2016–17 |
This year, we started to develop an APVMA Digital strategy to enable the operation of the APVMA from Armidale. See also Key activity: Ensure a high level?of?organisational health and financial viability and Key activity: Implement the IT Strategic Plan to support information management, staff capability and service?delivery. |
Key activity: Implement recommendations from the Protective Security Policy Framework (PSPF) review | ||
---|---|---|
Performance measure | Source | Result against performance measure |
PSPF recommendations? implemented |
Operational plan 2016–17 |
This year:
|
Key activity: Ensure organisational sustainability | ||
---|---|---|
Performance measure | Source | Result against performance measure |
Ensure capability, culture and financial sustainability |
Operational plan 2016–17 |
This year:
|
Key activity: Implement the APVMA People Strategy | ||
---|---|---|
Performance measure | Source | Result against performance measure |
Improve workforce stability |
Operational plan 2016–17 |
A number of measures are being implemented to increase the stability of our current and future workforce, including:
|
Staff engagement | Operational plan 2016–17 |
This year 93% of eligible APVMA staff voted?in the March 2017 ballot for the enterprise agreement; of those that voted,?56% voted ‘yes’ to a new enterprise agreement. |
No preventable work health and safety incidents requiring notification to the regulator/Comcare |
Operational plan 2016–17 |
This year there were no incidents requiring notification to Comcare. |
Key activity: Closely manage the APVMA budget | ||
---|---|---|
Performance measure | Source | Result against performance measure |
Maintain equity? reserve?targets |
Operational plan 2016–17 |
A cost base review commenced as a first step in identifying business costs to support the development of a revised cost recovery impact statement and to inform the future APVMA’s equity target. |
Key activity: Implement the Learning and Development Strategy | ||
---|---|---|
Performance measure | Source | Result against performance measure |
Strategy milestones? are?met |
Operational plan 2016–17 |
The APVMA Learning and Development Strategy was endorsed by the executive team in 2016 and refined in 2016–17 before the announcement that the APVMA would move to Armidale in 2019. This announcement has resulted in an organisational refocus for learning and development, with an increased focus on technical and scientific training. See also Key activity: Ensure a high level of organisational health and financial viability and performance measure Improve workforce stability within Key activity: Implement the APVMA people strategy. |