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Annual Report 2015-16—Appendix A: Progress against APVMA operational plan 2015-16 initiatives
The following tables summarise progress against each of the initiatives articulated in the APVMA operational plan 2015–16. The following key applies to each response:
| Initiatives | Progress | Comment |
|---|---|---|
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Strategy 1: Deliver regulatory decisions that are timely, science-based and proportionate to the risks being managed. |
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Key result area: regulatory decisions are completed within timeframes |
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Assess applications for (PAA), registration of products and permits and approval of active ingredients |
Completed |
Refer to performance statistics in Table 7 |
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Implement new legislative requirements for chemical review |
Completed |
Legislation and new process in place. See 'Chemical review' (apvma.gov.au/node10916) |
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Key result area: actions undertaken are proportionate to the regulatory risk being managed |
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New risk assessment framework finalised by June 2016 |
Ongoing |
A conceptual framework for the risk assessment was completed in December 2015 Work is now progressing to run a pilot in 2016–17 |
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Compliance and enforcement strategy 2015–17 finalised and published |
Completed |
Strategy available on the APVMA website, see 'Corporate documents' |
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Framework for regulating spray drift finalised by December 2015 |
Ongoing |
Targeted consultation with stakeholders on the APVMA's operating principles in relation to spray drift risk was undertaken in 2015–16 The review of this framework is continuing |
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Framework in place to provide assurance about the quality of APVMA decision making |
Ongoing |
A range of activities have begun and are in various stages of development:
|
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Design and implement a contestable efficacy pilot |
Completed |
A contestability pilot for efficacy assessments is on track. Activities completed include:
|
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Streamline approach to veterinary residues by publishing and implementing the Joint FAO/WHO Expert Committee on Food Additives (JECFA) review findings by February 2016 |
Completed |
The recommendations from the JECFA report were reviewed and implemented |
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Revise criteria for when efficacy is a relevant consideration in assessing an application; for implementation from 1 July 2016 |
Partially completed |
Consultation process was completed to ascertain possible amendments to the efficacy legislative instrument Results are currently being assessed by the APVMA |
|
Complete a review of the approach to licensing and auditing of veterinary manufacturers with implementation from 1 July 2016 (if applicable) |
Ongoing |
A consultant was engaged to undertake the review |
|
Complete crop grouping project to group similar crop types for minor use consideration |
Ongoing |
A consultation process was completed on a draft Australian Publication of the list and identification of representative crops is continuing |
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Review all permits to identify candidates that can be moved to registered product labels |
Ongoing |
Of the 563 permits examined, 400 are suitable for further review Industry will be consulted in 2016–17 to ascertain if their permit approvals should move to permanent label registration |
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Publish 2015–17 compliance and enforcement strategy by December 2015 |
Completed |
Strategy available on the APVMA website, see 'Corporate documents'(apvma.gov.au/node/11026) |
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Review GMP audit schedule and implement from 1 January 2016 |
Completed |
Review completed Findings were presented at the APVMA industry seminar in May 2016 |
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Refined compliance and enforcement risk model applied to new allegations from 1 July 2015. Responses employ graduated tools and are proportionate to risk |
Completed |
A risk management framework included in the APVMA compliance and enforcement strategy, which can be found under 'Corporate documents' (apvma.gov.au/node/11026), focuses on a risk-based approach that responds to risks in a proportionate manner based on the assessment of risks |
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Key result area: regulatory science underpins quality regulatory decision making |
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Develop APVMA regulatory science strategy |
Completed |
The regulatory science strategy is available at apvma.gov.au/node/11026 |
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Identify opportunities to align |
Completed |
Report completed and findings presented at the APVMA industry seminar in May 2016 in Melbourne |
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Expand the content of 'Our science' web page |
Completed |
Science web pages published. See 'Our science' (apvma.gov.au/node/15486) |
|
Develop staff capability by providing training in regulatory science and new chemical/biological technologies |
Completed |
Training provided to staff on mastitis therapy, 'gene drive' technology, neonicotinoids and pollinators and bioequivalence |
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Progress chief scientist projects: |
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Completed |
Report provided to SQC with generics guidelines to be completed in 2016–17 |
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Partially completed |
Report provided to SQC with additional information made available on 'Our science' at apvma.gov.au/node/15631 |
|
Completed |
Received final draft of the risk profiling decision tree incorporating industry feedback |
|
Partially completed |
Draft report received. Comparison work on European Food Safety Authority and United States Environmental Protection Agency worker exposure continues Bystander and resident comparison exposure calculations have been received from expert consultant |
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Partially completed |
Report completed and reviewed by SQC |
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Ongoing |
Targeted consultation with stakeholders on the APVMA's operating principles in relation to spray drift risk The review of this framework is continuing |
|
N/A |
This project has stopped |
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Develop and implement a framework for obtaining external expert scientific advice |
Ongoing |
Ongoing |
| Initiatives | Progress | Comment |
|---|---|---|
|
Strategy 2: Reduce the burden on industry in complying with regulatory requirements |
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Key result area: unnecessary impediments to the efficient operation of regulated entities are removed |
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Hold two CEO-only forums with key industry stakeholder groups to discuss APVMA performance and key issues |
Completed |
The CEO held and attended regular meetings and forums with key industry stakeholder groups to discuss performance and other issues |
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Conduct a series of industry information sessions |
Completed |
Industry information sessions were held in August and October 2015 and May 2016 |
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Hold quarterly briefings for APVMA staff about industry-specific issues/trends/practices |
Completed |
The APVMA conducted 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 |
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Undertake an environmental scan with stakeholders each year for publishing in the operational plan |
Completed |
Environmental scan completed and provided to the Minister in June 2016 Key aspects incorporated into the 2016–17 operational plan |
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Develop and implement a plan for review and adoption of international guidelines and standards, including a website to communicate decisions to stakeholders |
Partially completed |
Two public consultations were undertaken in 2015–16 on the APVMA's framework for the use of international assessments Detailed information has been published on the website and the framework will be implemented in 2016–17 The APVMA continued its program of international engagement in 2015–16, including participating in key international scientific and regulatory forums, such as OECD, VICH and WHO |
|
Identify opportunities to improve data sharing and access to assessment with international regulators |
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Develop and implement an international engagement strategy |
Partially completed |
|
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Partner in at least three GJRs |
Completed |
The first joint review of a veterinary medicine (meloxicam) completed with Canada and New Zealand Completed GJR: oxathiapiprolin Ongoing GJR: bicyclopyrone, flupyradifurone and cyclaniliprole |
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As part of the OECD network and with GJR partners, participate in a review of the conduct of GJRs to streamline processes and ensure it meets the needs of industry and regulators |
N/A |
The APVMA is continuing to engage with the OECD with a view to improving the GJR partnership process |
|
Participate in relevant OECD and VICH activities designed to harmonise assessment, data requirements and/or registration systems across international regulators |
Completed |
APVMA participated in the 33rd meeting of the VICH in June 2016, and provided a report on survey of RNAi regulation for Regulatory Reference Groups RSGs and RRGs and contributed to the crop field test and rotational residues guidelines |
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Complete a usability review of the external portal, and implement enhancements |
Partially completed |
The useability review commenced in 2015–16 with the report and recommendations considered in early 2016–17 |
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Enhance online automatic validation of applications to facilitate complete applications |
Ongoing |
A range of activities were completed within these initiatives, including:
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Streamline application process through end-to-end project management |
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Continuously improve access to external scientific reviewers |
Completed |
A larger number of external science reviewers are now available to conduct technical assessments on behalf of the APVMA in a range of fields, including efficacy, toxicology, health and safety, and environmental science |
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Identify opportunities for the further expansion of Objective Workflow |
Completed |
Twenty workflows were developed encompassing 112 active users of Objective Workflow |
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Collect annual returns on active information for the Department of Agriculture and Water |
Completed |
Developed and deployed an online system to collect annual returns |
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Review GMP business processes and implement administrative enhancements |
Ongoing |
GMP business processes were mapped and the associated IT requirements articulated However, new administrative enhancements were not implemented this year because |
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System developed to capture and report on data on assessment of non-compliance allegations and how compliance tools are used |
Completed |
The internal records management system was identified as the most appropriate system to collect and extract compliance statistics in the short to medium term |
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Undertake compliance assessments and relevant compliance activities |
Completed |
The compliance and enforcement program focuses on education, engagement and enforcement in alignment with the strategy |
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Review existing memorandum of understanding with Therapeutic Goods Administration (TGA) and identify opportunities to minimise duplication of audits for manufacturers of mutual interest |
Completed |
A new draft bilateral MOU with TGA was completed |
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Progress EU recognition of APVMA GMP audits to facilitate export to |
Completed |
EMA and EU discussions held in May 2016 Discussions are underway with industry to ascertain the level of interest in progressing EU recognition of our audits |
|
Explore options for conducting additional joint audits |
Deferred |
This activity was deferred pending the outcome of the GMP review |
|
Develop MOUs with partner regulators for exchange of compliance and enforcement information |
Ongoing |
Work commenced with Australian Sports Anti-Doping Authority to develop an MOU for law enforcement and information sharing |
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Conduct an audit of refusals and section 159 notices to demonstrate 100% are within policy parameters |
Completed |
A sample audit of files was conducted to ascertain whether refusals given under various provisions of the Agvet Code and the issuing of notices under s.159 of the Agvet Code met both policy parameters (for example relevant CEO directions and work instructions) and legislative requirements While the audit identified some administrative issues, it indicated that the decisions were technically sound |
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Develop system to capture and report average number of requests for information |
Completed |
Information is requested under s. 159 These requests can be captured through the APVMA's business intelligence tools |
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Identify options to improve adverse experience reporting (AER) through process automation and integration of AER intelligence |
Ongoing |
An options paper is in development |
| Initiatives | Progress | Comment |
|---|---|---|
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Strategy 3: Build a client-focused approach to service delivery, committed to continuous improvement |
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Key result area: the APVMA is open and transparent in its dealings with regulated entities |
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Design and implement a system to publish performance information |
Completed |
A system was developed to prepare key APVMA performance information for publication Information was published on our website in February, May and August 2016 at 'Performance statistics' (apvma.gov.au/node/19741) |
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Implement a survey to benchmark and track client experience across a range of criteria for APVMA service delivery |
Ongoing |
The survey design brief was prepared and the survey is expected to be run in 2016–17 |
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Communication of compliance and enforcement outcomes is consistent with the compliance and enforcement strategy |
Completed |
Key compliance performance information has been published on the APVMA website through CEO blogs, regulatory updates and other media pieces We continue to add new information |
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Publish new chemical review work plans |
Completed |
Work plans for chemical review were published and can be accessed via apvma.gov.au/chemicals-and-products/chemical-review/listing |
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Review existing online feedback system to inform the design and implementation of service delivery |
Completed |
A review was completed and implementation of the review findings will begin in 2016–17 |
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Key result area: communication with regulated entities is clear, targeted and effective |
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Design and implement a new model for PAA |
Completed |
A new PAA process was implemented from |
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Design and implement a system to capture and report data relevant to customer service standards |
Ongoing |
The APVMA is currently exploring options to capture and report on service statistics via a CRM tool |
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Implement a stakeholder perceptions survey to establish baseline metrics on satisfaction |
Ongoing |
The survey design brief was prepared and the survey will be |
|
Refresh the design of the APVMA's regulatory updates, and seek quarterly user feedback on content relevance |
Partially completed |
A regulatory update subscriber survey was conducted in 2015–16 to seek feedback Improvements will be implemented as part of the useability review of our online services and channels |
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Design and implement a system to regularly check stakeholder views and experiences with APVMA website |
Completed |
A website feedback mechanism is now available on every page of the APVMA website The information collected is passed to individual page owners for appropriate action |
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Design and implement a program of content review for guidance material on the website |
Completed |
A web governance policy was developed that includes a content review process, and identifies owners for each page on the APVMA website |
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Key result area: the APVMA actively contributes to continuous improvement of regulatory frameworks |
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Design and implement a new stakeholder consultation framework |
Ongoing |
A consolidated stakeholder list for key companies, industry associations and government agencies was prepared as part of the stakeholder consultation framework |
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Engage with states and territories on initiatives as required |
Completed |
The APVMA regularly engages with states and territories and held a face-to-face forum with states and territories in 2015–16 |
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Offer hosting of twice-yearly forums for states and territories |
Completed |
A state forum was held to discuss minor use permits |
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Hold monthly meetings with the Department of Agriculture and Water Resources about legislative frameworks and implementation |
Completed |
Regular meetings held with the Department of Agriculture and Water Resources with the following items progressed:
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Provide input as requested to government documents, including ministerials, policy documents and legislative proposals |
Completed |
Requests completed as required. Key activities include:
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| Initiatives | Progress | Comment |
|---|---|---|
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Strategy 4: Operate as a contemporary, high-performing and efficient organisation |
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Key result area: organisational health and financial viability |
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Implement a new quality system by 30 June 2016, including the development of a business model and definition of key APVMA business process |
Completed |
A new quality management system has been implemented, and instructional material is being added to it Key business processes for the APVMA registration process have been identified and defined |
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Complete a new cost recovery impact statement based on current fee structure for implementation from 1 July 2016 |
Partially completed |
An activity-based costing exercise was completed and a possible new fee structure identified This will likely be implemented in October 2016 following ministerial approval |
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Complete a refresh of desktop PCs by December 2020 |
Completed |
New desktop PCs were rolled out in March 2016 |
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Conduct a pilot of secure cloud infrastructure for public-facing IT systems |
Ongoing |
This work has been delayed, but this activity will resume following the development of an APVMA enterprise architecture and ICT strategic plan |
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Comply with the PSPF and review APVMA compliance against the ASD top 35 mitigation strategies for cyber security |
Completed |
KPMG completed an external PSPF review The report provided a basis to develop a cyber security road map This task will be completed parallel to the development of an ICT strategic plan |
|
Undertake a project to cleanse the agvet database |
Completed |
Data cleansing was completed |
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Improvements to the APVMA's external and internal applications completed to agreed timeframes |
Completed |
Improvements were made within agreed timeframes and include the delivery of a new client module, security module, and tasks and milestones |
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Key result area: organisational health and financial viability |
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Develop and implement a new enterprise agreement (EA) |
Partially completed |
Draft EA provided to APVMA staff in May 2016 |
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Develop and implement a learning and development strategy flowing from the needs identified in the capability review by June 2016 |
Completed |
A learning and development strategy was developed and delivered to APVMA staff in May 2016 Implementation has started and will continue in 2016–17 |
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Implement a learning network to better tailor and target learning requirements |
Completed |
A learning network of 10 members is in place with terms of reference and governance documents High-priority learning requirements were identified for several Microsoft software products Audits were completed and training delivered |
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Implement a corporate training calendar focused on personal efficiency and management, by 30 June 2016 |
Completed |
A training calendar was developed. Training has been delivered on a range of topics, including scientific analysis, use of spreadsheets, legal, administration and management principles |