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

Strategy 1: Deliver regulatory decisions that are timely, science-based and proportionate to the risks being managed.

Key result area: regulatory decisions are completed within timeframes

Assess applications for (PAA), registration of products and permits and approval of active ingredients

Completed

Refer to performance statistics in Table 7

Implement new legislative requirements for chemical review

Completed

Legislation and new process in place. See 'Chemical review' (apvma.gov.au/node10916)

Key result area: actions undertaken are proportionate to the regulatory risk being managed

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

Compliance and enforcement strategy 2015–17 finalised and published

Completed

Strategy available on the APVMA website, see 'Corporate documents'

(apvma.gov.au/node/11026)

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

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:

  • creation of an internal guide to safety, efficacy, trade and labelling legislative criteria for agricultural and veterinary chemical products
  • publication systems for decision summaries
  • creation of a new decision document

Design and implement a contestable efficacy pilot

Completed

A contestability pilot for efficacy assessments is on track. Activities completed include:

  • public and industry consultation
  • list of pilot reviewers compiled
  • pilot guidance documents are available at 'Contestability of the efficacy assessment' (apvma.gov.au/node/18691)

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

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 
crop list

Publication of the list and identification of representative crops is continuing

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

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)

Review GMP audit schedule and implement from 1 January 2016

Completed

Review completed

Findings were presented at the APVMA industry seminar in May 2016

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

Key result area: regulatory science underpins quality regulatory decision making

Develop APVMA regulatory science strategy

Completed

The regulatory science strategy is available at apvma.gov.au/node/11026

Identify opportunities to align 
the APVMA's regulation of veterinary medicines with those of overseas jurisdictions

Completed

Report completed and findings presented at the APVMA industry seminar in May 2016 in Melbourne

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

Progress chief scientist projects:

   
  • pharmaceutical equivalence

Completed

Report provided to SQC with generics guidelines to be completed in 2016–17

  • a model framework for the regulation of products of emerging technologies

Partially completed

Report provided to SQC with additional information made available on 'Our science' at apvma.gov.au/node/15631

  • risk profiling of imported live 
    micro-organisms for use in 
    veterinary vaccines

Completed

Received final draft of the risk profiling decision tree incorporating industry feedback

  • suitability of new United States of America and European Union 
    worker exposure methods for adoption in Australia

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

  • tier-3 aquatic exposure modelling (dryland cropping component)

Partially completed

Report completed and reviewed by SQC

  • develop a regulatory framework to support a revised spray drift policy

Ongoing

Targeted consultation with stakeholders on the APVMA's operating principles in relation to spray drift risk

The review of this framework is continuing

  • scoping the development of an approach to assessing fumigants

N/A

This project has stopped

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

Key result area: unnecessary impediments to the efficient operation of regulated entities are removed

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

Conduct a series of industry information sessions

Completed

Industry information sessions were held in August and October 2015 and May 2016

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

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

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

Develop and implement an international engagement strategy

Partially completed

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

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

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

Enhance online automatic validation of applications to facilitate complete applications

Ongoing

A range of activities were completed within these initiatives, including:

  • a process map for Item 7 applications
  • a release process for advice reports on applications from the Scientific Assessment and Chemical Review program
  • updating of the preliminary assessment work instruction
  • mapping of s. 14 criteria
  • review of e-label portal

Streamline application process through end-to-end project management

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

Identify opportunities for the further expansion of Objective Workflow

Completed

Twenty workflows were developed encompassing 112 active users of Objective Workflow

Collect annual returns on active information for the Department of Agriculture and Water

Completed

Developed and deployed an online system to collect annual returns

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 
of competing requirements for 
IT resources

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

Undertake compliance assessments and relevant compliance activities

Completed

The compliance and enforcement program focuses on education, engagement and enforcement in alignment with the strategy

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

Progress EU recognition of APVMA GMP audits to facilitate export to 
the EU

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

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

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

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

Strategy 3: Build a client-focused approach to service delivery, committed to continuous improvement

Key result area: the APVMA is open and transparent in its dealings with regulated entities

Design and implement a system to publish performance information 
and decisions

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)

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

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

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

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

Key result area: communication with regulated entities is clear, targeted and effective

Design and implement a new model for PAA

Completed

A new PAA process was implemented from 
3 November 2015

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

Implement a stakeholder perceptions survey to establish baseline metrics on satisfaction

Ongoing

The survey design brief was prepared and the survey will be 
run in 2016–17

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

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

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

Key result area: the APVMA actively contributes to continuous improvement of regulatory frameworks

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

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

Offer hosting of twice-yearly forums for states and territories

Completed

A state forum was held to discuss minor use permits

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:

  • implementation of legislative changes relating to overseas manufacture, name and web content on primary/secondary applications
  • comments on GHS review consultation paper
  • IT business system changes for excipient substitution
  • IT changes for applications with item numbers of 13A and 29

Provide input as requested to government documents, including ministerials, policy documents and legislative proposals

Completed

Requests completed as required. Key activities include:

  • work instruction for supply chain, and logistics
  • submission for Regulation of Agriculture Productivity Commission
  • information for agricultural innovation inquiry and Hendra virus vaccine inquiry
Initiatives Progress Comment

Strategy 4: Operate as a contemporary, high-performing and efficient organisation

Key result area: organisational health and financial viability

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

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

Complete a refresh of desktop PCs by December 2020

Completed

New desktop PCs were rolled out in March 2016

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

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

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

Key result area: organisational health and financial viability

Develop and implement a new enterprise agreement (EA)

Partially completed

Draft EA provided to APVMA staff in May 2016

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

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

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

 

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