• commenced assessment of 2910 applications for products, actives and permits, and finalised 2453 applications (Table?4)
• achieved overall performance rates of 69%?within timeframe, including
  • 59% for product registration (pesticides 45%, veterinary medicines 77%)
  • 88% for active approvals
  • 71% for permits.

• closed 199?formal matters
• worked on more than 200?enquiries regarding agvet law or processes.

• one statutory recall notice (a Stop Supply) was?gazetted within 14?days
• three other compliance statutory notices (Notice?to produce and Notice to attend), were?issued; however, they were not required to?be gazetted.

• products: 6.7?months
• actives: 5.2?months
• permits: 3.8?months.

Policies are in place and regularly assessed.

The APVMA developed new guidance for industry on the use of international data, standards and assessments.

See also Key activity: Align technical guidelines and guidance material with international requirements, unless there is a justifiable reason not to and Key activity: Develop an online ‘fast?tracked’ registration system for applications requiring lower levels of regulatory intervention

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.?

See also 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.

The APVMA has a publicly available Compliance and enforcement strategy 2015–17 that has three central compliance and enforcement approaches: education, engagement and enforcement.
Supporting this strategy is a compliance plan for 2016–17, which includes a risk-assessment approach that is embedded in our case management workflows. Risk assessment includes consideration of the seriousness of the noncompliance and the degree to which safety of?human health, animals or the environment may?be compromised. The actions undertaken by the Compliance and Monitoring section aim to ensure that any enforcement action is proportionate and efficient.

The APVMA’s Enforcement Committee oversaw critical decisions on compliance and enforcement matters, such as the use of investigative warrants and statutory enforcement notices.

• developed a cross-agency (APVMA, Department of Agriculture and Water Resources) decision tree for risk profiling of?live imported microorganisms intended for?use in veterinary vaccines. The Animal Division of Department of Agriculture and?Water Resources has assumed responsibility for assessment of risk for genetic recombination/reassortment
• finalised consultation and drafted a report on antimicrobial resistance. Release of the report is scheduled for the first half of 2017–18?
• developed and documented an approach to the regulation of new agvet chemical products based on emerging technologies. ‘Ecological risk assessment of nano-enabled pesticides: A?perspective on problem formulation’ has been?submitted to the Journal of Agricultural and?Food Chemistry?
• finalised consultation and published a report on Regulatory Scientist Training and Skills Requirements Survey Results, completed in November 2016, which has informed the development of the Accelerated Regulatory Science Training Program, an initiative that will?be deployed in 2017–18?
• delivered presentations to staff on gene-drive technology, briefed inductees on the role of the Office of the Chief Scientist, and prepared staff presentations on veterinary drug residues (to?be?delivered in 2017–18). On 8?November 2016 the APVMA held a science feature day in Canberra as part of a two-day industry information and education session. The theme of the day was ‘Regulatory science and innovation in the global context’. Several expert speakers shared their ideas about what the future of regulation and science in the global context might be, and how that may impact industry and regulators such as the APVMA. The event was attended by more than 180 people.

• completed the reviews of omethate (December 2016) and dimethoate (March 2017) within the expected completion dates
• progressed the remaining 15?reviews and published reports into

  • paraquat toxicology (October 2016)?

  • neomycin target animal safety (January 2017)

  • chlorpyrifos toxicology (May 2017)?

  • methiocarb occupational health and safety (May 2017)

• completed a detailed assessment of glyphosate.

• used stakeholder feedback to improve guidance material and the user experience of online information registration systems?
• mapped end-to-end business processes to streamline assessment processes, and?identified and implemented lower regulatory approaches
• continued to engage clients and stakeholders to better understand their needs and our operating environment?
• extended our environmental scan as part of?agency planning?
• invited registrants to present to APVMA staff on the process of product discovery, research and development, and post market activities to support a broader understanding of the operating environment for regulated entities.

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.

• used IT improvements and internal process reform to reduce the time taken to process lower-risk applications
• allowed up-front fee payment, saving time for applicants and the APVMA.

As at 30?June 2017:

• we had received 36?applications: seven met the fast-track criteria, 27 did not meet the fast-track criteria and have been processed via the normal item?8 pathway; and two?were withdrawn
• the seven eligible applications had their products registered in an average of 26?days; slightly more than the 21-day timeframe set for the pilot and slightly less than the three-month legislative timeframe for these applications
• we are continuing the fast-track registration pathway for applications that meet the criteria set for the pilot?
• we are reviewing the pilot to identify business processes and legislative changes?that could improve the process before we increase the types of applications that can use the pathway.

• we continued consultation with members of the dairy sanitiser and antifouling paint industries to determine how this approach may be useful for those products. In?2017–18 we plan to explore this approach with other industry sectors where?appropriate?
• we are developing guidance material for industry wanting to develop standards.

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:

• 15 assessments by comparable international regulators contributed to component assessments across human health, residues and environment
• publicly available international assessments were used to establish environmental endpoints for an additional 30?assessments?
• international assessments (Joint FAO/ World Health Organization Meetings on Pesticide Residues) supported the residues?component assessments for 24?minor use permits.

• defining acceptable international assessments, including their potential scope and a list of organisations whose assessment reports we will accept?
• developing guidelines for the submission of an international assessment, including criteria that the assessment must fulfil to be acceptable to the APVMA (eg?the active constituent or product in the international assessment must be identical to the active constituent or product intended for approval or registration in Australia)?
• developing requirements covering the submission of multiple assessments and underlying data or studies?
• confirming how we will use the data provided, including a clear statement that the APVMA does not simply adopt the conclusions of an international assessment—each assessment must be fit?for purpose and supported by studies that fulfil regulatory requirements?
• providing clarity to applicants on the Australian-only information contained in?APVMA guidance material.

We provided guidance to our staff on how to handle international assessments and industry can now submit international assessments in support of registration applications.

• the APVMA launched a pilot project to enable applicants to obtain efficacy assessments before submitting an application
• the pilot opened to submissions on 1?July?2016 as scheduled
• 10 applications were received through the?pilot.
• The pilot has been extended by 12?months to?allow more applications to be considered.

• 199 compliance cases were resolved; 100% of allegations were assessed on time
• 83% of all allegations were assessed as low risk and were resolved through education and negotiated compliance
• for matters assessed as medium or high risk, engagement and various enforcement strategies were used, including
  • four statutory notices
  • seven formal warnings
  • five infringement notices
  • (totalling?$31?500) – two investigation warrants
  • two monitoring warrants
  • one compulsory stop supply

• conducted proactive monitoring activities in response to concerns from industry and other regulators about certain product types in the marketplace, ncluding
  • sampling and testing approved trifluralin active and formulated products containing trifluralin and fipronil; the active and products analysed were found to be within specification and legislative requirements
• continued engagement with external law enforcement and regulatory bodies to limit the supply of unregistered products in the Australian marketplace, including
  • 27?engagements with the Australian Border Force in response to alert activations of suspected unregistered chemical products being imported into Australia; some of the unlawful products were re-exported and 16?letters were issued to the Customs Comptroller General to request the disposal of imported unregistered chemical products
• met with horse and greyhound racing regulators Australia-wide as part of a joint?effort to disrupt the flow of unregistered veterinary chemical products in the racing industry
• issued three evidentiary certificates to assist racing integrity units in their investigations.

• issued two notices to produce and one notice to attend to compel regulated entities to provide information relevant to investigations; the use of these coercive powers was endorsed by the APVMA’s Enforcement Committee
• conducted label audits of 182?registered products (products containing clethodim or fenamiphos; and sheep ectoparasiticide and household insecticide products)
• contacted 59?companies with requests for label information and sent advisory letters outlining issues requiring rectification.

• manufacturers are divided into categories based on the types of products they produce and are audited in accordance with the manufacturing risk associated with that product; for example, sterile product manufacturers (classed as category?1) are audited more frequently than manufacturers of premix-type products (category?4), because the good manufacturing practice (GMP) requirements for sterile products are much more involved
• the number and severity of nonconformances is assessed to help determine the interval between audits; for example, a manufacturer with a low number of minor non-conformances will have a longer audit interval, whereas a manufacturer with a high number of major?non-conformances will have a shorter?interval.

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.

• 207 new compliance cases were progressed, applying proportionate responses to bring contravening parties back into compliance and provide future deterrence
• two investigative warrants to gather evidence were issued
• a compulsory recall notice was issued to stop the supply of an unregistered chemical product
• 27 importations were checked in three maritime ports. Most of these were compliant and not held at the border; two imports of around 40?tonnes of unregistered agricultural chemical products were returned to their source countries, 200?litres of unregistered termiticide were referred to the Australian Border Force for disposal, and around two?litres of unregistered veterinary performance chemical products were detained and either re-exported or referred to the Australian Border?Force for disposal.

• 207 new compliance cases were progressed, applying proportionate responses to bring contravening parties back into compliance and provide future deterrence
• two investigative warrants to gather evidence were issued
• a compulsory recall notice was issued to stop the supply of an unregistered chemical product
• 27 importations were checked in three maritime ports. Most of these were compliant and not held at the border; two imports of around 40?tonnes of unregistered agricultural chemical products were returned to their source countries, 200?litres of unregistered termiticide were referred to the Australian Border Force for disposal, and around two?litres of unregistered veterinary performance chemical products were detained and either re-exported or referred to the Australian Border?Force for disposal.

• requested only if it is necessary to advance the application, particularly if it is critical to?the audit
• promptly reviewed to enable the application to progress and to facilitate the audit of the facility.

• the usability of the APVMA website was reviewed (October 2016) to gain a clearer understanding of what applicants and other users need from the website and online services portal; recommendations were prioritised for implementation in early 2017
• Google search was implemented on the website in February 2017 and analytics have?demonstrated improvements to our user searches and discoverability of?guidance material
• we published the Guide to completing an online application and Guidance for submission of international data standards and assessments
• we developed project plans for a series of Agricultural Competitiveness White Paper and business improvement activities to be implemented between 2017 and 2019 to improve satisfaction with regulatory guidance materials
• satisfaction with online information and guidance material was monitored and feedback actioned by relevant business areas
• we have redesigned the Our Science web?pages and content will be implemented in?2017–18
• we received and addressed where required?to
  • 40% positive, 30% negative, 30% neutral ratings provided through a feedback mechanism at the bottom of each web page containing guidance material
  • 6% positive, 43% negative, 51% neutral feedback reports through a form on the online services portal.

• subscriptions to the APVMA Gazette grew to 2354, an increase of 6.4%, indicating continued satisfaction with information about APVMA decisions communicated through this publicly available channel
• we implemented a case manager model for enquiries which has improved the continuity of handling
• at least 7100?calls and?8800 emails were received by the APVMA Case Management and Administration Unit, representing a decrease of approximately 25% on the previous year. The decrease in general enquiries has been influenced by the successful implementation of an account management system, with many applicants able to contact their dedicated case manager directly. A?restructured phone system has diverted calls to the correct APVMA area?without the need for triaging through the Case Management and Administration Unit.

• there were around 3200?unique visits to the public consultation pages of the APVMA website, indicating strong visibility and accessibility of APVMA consultations
• we consulted publicly on 45?regulatory decisions and proposed changes to operational policy and development of guidelines, including
  • finalising APVMA policies and guidance material for the use of international standards, assessments and data
  • review of the good manufacturing practice audit framework
  • consideration of a revised policy for prioritisation of APVMA workload and application assessments
  • continuation of pilot programs for applicants to source efficacy assessments before application and for fast-track registration systems for applications of low gulatory concern
  • a proposal to leverage assessments and decisions in New Zealand for non–food producing animals
  • proposed changes to safety and use instructions through the chemical reconsideration of dimethoate
• we held a workshop (February 2017) to establish client expectations for improved regulatory guidance material.

• addressing core usability issues
• undertaking a content audit
• undertaking a terminology review
• reviewing information architecture and testing any new architecture with users
• reviewing the user interface design of?the homepage to provide users with?direct paths to key site features and content.

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.
Industry sessions complemented APVMA’s?traditional consultation channels?in 2016–17.
See Key activity: Remove unnecessary impediments to the efficient operation of?regulated entities.

• phone messages and emails were checked daily by the enquiries team and replies made within the one-day standard for phone calls and five-day standard for written enquiries
• we responded to 35 media inquiries; 70% of responses were within agreed deadlines
• website content review systems were appropriately maintained and feedback from the website was monitored and acted on daily to improve online information
• content published to the APVMA website was continuously quality checked to ensure compliance with Australian Government online and accessibility standards.

• 100% of applicants agreed that the information and guidance material for?making a PAA request was clear
• 100% of applicants advised that the advice received would assist them in preparing an application to the APVMA
• 92% agreed that the online system for?submitting a PAA application was easy to use
• 83% of applicants were satisfied with the clarity of the advice
• 83% agreed that the format, fees and timeframes were appropriate.

• we engaged 85?people through 39 individual recruitment actions and five bulk processes; induction and onboarding have been given a high priority
• 100% of those new employees have completed online and face-to-face induction training
• an audit of the APVMA’s knowledge and knowledge management practices was conducted and led to the development of a knowledge management strategy
• we organised career management sessions for eligible staff; these have been well attended and positively received
• 21 employees have completed a Diploma of Leadership and Management
• we designed and offered a range of activities including Health Week to support our staff
• the APVMA Social Club continues to conduct events.

• mapped the registration process for key?application types
• conducted a detailed review of the existing registration process
• identified process improvements that support efficiency gains during the relocation period
• identified business requirements for a new application registration system.

• online services to support the electronic submission of agvet applications by registered users
• an internal portal for managing the end-to-end registration process for agvet applications
• an EDRMS to support organisational information management
• an online learning management system
• an internal instructional material library (IML) for the proactive management of APVMA policies and processes.

This year, several initiatives were completed to improve service delivery in?these areas, including:

• an upgrade of the EDRMS to ensure its?effective operation on APVMA mobile?tablet devices
• development of an online induction module to introduce new staff to APVMA information management practices
• introduction of new modules into the internal portal to support efficient management of product data, actives data and finance data associated with agvet applications
• introduction of new workload management features into the internal portal to support the management of tasks and milestones within the end-to-end registration process
• improvements to the online services site, including
  • annual return of actives reporting
  • agvet application status dashboard reporting
  • up-front payment options to include full fees
  • increased registration renewal options
  • a fast-track application system for certain application types
• commencement of work to redevelop our record authority in preparation for the digitisation of historic paper records.

• we implemented the IML, which contains guidelines, accountable authority instructions, policies, decision maps, process maps, work instructions, forms, notices, templates and reference material; these combine to outline the approved work practices for APVMA staff
• we reviewed and subsequently updated around 27% of our instructional material
• we conducted a number of major projects that will increase the efficiency and effectiveness of the work instruction review processes; the revision or creation of the IML documentation will reflect the project outcomes.

• the project delivered new capability to support efficient management of product, actives and finance data; this has positioned the APVMA to decommission four legacy systems (iEARS, Agvet, NPRIS and the ATS Finance Module)
• the legacy records management system RecFind and the legacy corporate reporting tool Cambron were?decommissioned.

• we reviewed the project on the end-toend registration process, following the announcement of the APVMA relocation
• as part of the review, work on current and future state process mapping was accelerated and was delivered on time at the end of March 2017
• Phase?2 of the project started on 1?April?2017 to identify process inefficiencies and opportunities for improvements.

• This year, we engaged external consultants to review the GMP programs and consider the APVMA approach to auditing and licensing, the approach of comparable international regulators, and possible improvements to increase program effectiveness. The completed review:
• recommended that we implement a second-party auditing model with a view to implementing a first-party auditing model within five?years; this aims to improve international harmonisation of GMP for veterinary chemical products
• describes 10?key steps to achieve implementation that need to be considered by the APVMA and its stakeholders.

• development of the Information management strategic plan 2016–20, to align the APVMA to the?whole-of-government Digital Continuity 2020 strategic road map
• development of an information management governance framework to ensure effective management of information across the agency.

• we continued to improve our performance as measured against the PSPF and the essential eight?strategies for mitigating cyber incidents
• we significantly improved APVMA security patching of desktop and server?operating systems
• we significantly reduced spam by implementing a reputation-based filter
• we started monthly cyber incident reporting to the executive team.

• the new Enterprise Agreement 2017–20 was agreed to by staff
• the people strategy and learning and development outcomes were implemented
• flexible work arrangements for staff were supported
• we developed and designed the Diploma of Government in Regulatory Science for launch in July 2017
• we developed and are implementing our knowledge management strategy.

• a direct focus on retaining existing staff?through the development of an APVMA retention policy
• extending the People Strategy 2016–19 undertaking workforce planning to identify current and future workforce needs
• supporting staff by providing opportunities to participate in the accelerated science training program that is being implemented as part of the revised Learning and Development Strategy
• a contemporary, strategic recruitment strategy to identify future recruitment needs, appropriate candidate sources and new ways of attracting candidates to the APVMA.