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

Introduction

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

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

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

About the annual performance statement

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

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

These documents cover performance relating to:

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

Presented in this statement are the metrics underneath each performance indicator and a high-level summary of the outcomes for 2015–16. Cross-references to the APVMA regulator performance framework are provided.

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

The individual activities the APVMA undertook in 2015–16, as contained in the operational plan, directly relate to the performance indicators discussed in this statement. A report on progress of the activities in the 2015–16 operational plan is in Appendix A.

Timely regulatory decision making

In 2015–16, the APVMA commenced assessment of 5106 applications covering:

pre-application assistance
pesticide and veterinary medicine products
active constituents
permits
nominated agents and changes to holders (Items 8L, 8M and 8P)
technical assessments under Item 25
notifiable variations
import consents
certificates of exports.

Table 6: Summary of activities related to regulatory decisions in the APVMA July 2015 – June 2016
Types of regulatory? decisions	Commenced	Finalised/issued	In PRogress
Pre-application assistance	175	145	42
Product registration—pesticides	905	1029	408
Product registration—veterinary medicines	701	704	316
Actives	342	213	289
Permits	562	599	179
Items 8L, 8M, 8P	695	689	32
Item 25	15	24	12
Notifiable variations	736	696	37
Import consents	608	620	61
Certificates of export	367	429	30
Total	5106	5148	1406

PERFORMANCE INDICATOR: Percentage of applications completed within timeframes
Metric	Results	RPF reference
Timeframe performance met for 100% product registration*	66%	1.3.B
Timeframe performance met for 100% active approvals*	70%	1.3.B
Timeframe performance met for 100% permits*	70%	1.3.B
90% of consents to import are processed within 14 days	86%	1.3.B
100% of internal review requests addressed within the 90-day timeframe	63%	1.3.B
100% of pre-application assistance timeframes? are met	(old process) 36% (new process) 46%	1.3.B
Timeframes for chemical reviews are met	No chemical reviews were due for completion in 2015–16: however, the review of fenamiphos was completed? in July 2015	1.3.B

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

Timeframes for products, actives and permits

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

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

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

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

Quarterly performance against timeframes is published on our website under 'Performance statistics' (www.hungtuantextile.com/node/19741).

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

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

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

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

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

Timeframe performance for import consents

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

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

Figure 4: Timeframe performance for import consents 2015–16

Timeframe performance for import consents in 2015–16

Timeframe performance for pre-application assistance

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

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

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

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

Compliance, enforcement and licensing performance

PERFORMANCE INDICATOR: Percentage of compliance and enforcement activities completed within timeframes
Metric	Results	RPF reference
GMP audit program implemented as per APVMA-approved schedule	96 audits were completed? (16 more than the proposed program of 80 audits) 80% of audits were completed within timeframe and a further 9% within one week of the due date—see 'Performance statistics'(www.hungtuantextile.com/node/19741)	1.3.B
100% of statutory notices issued by compliance are gazetted in accordance with legislative requirements	The APVMA issued one statutory notice in 2015–16, which was gazetted in accordance with legislative requirements	1.3.B

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

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

Removing unnecessary impediments

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

PERFORMANCE INDICATOR: Demonstrated understanding of the operating environment for the regulated entities
Metric	Results	RPF reference
Four stakeholder forums held each year to discuss issues affecting regulated entities	The APVMA held more than four stakeholder forums and meetings with key industry associations throughout 2015–16 to discuss operational and other matters affecting agvet? chemical regulation	1.1.A
Three industry information and training seminars delivered each year	Three industry information and education sessions were held:? Melbourne, August 2015 Canberra, October 2015 Melbourne, May 2016	1.1.B
Four industry awareness workshops conducted by APVMA staff each year	The APVMA conducted more than four industry awareness sessions and workshops throughout the year, including a tailored workshop on the lifecycle of product development, and looking at the registration process from the applicant's perspective	1.1.C
Environmental scan published annually	The environmental scan was published as part of the?APVMA operational plan 2016–17. See 'Corporate documents' at (www.hungtuantextile.com/node/11026)	1.1.D

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

PERFORMANCE INDICATOR: International data guidelines, standards and assessments adopted to reduce effort to register agvet chemicals
Metric	Results	RPF reference
Demonstrated application of the policy for use of international standards, guidelines, assessments and decisions	There were 492 international guidelines adopted by the APVMA and published on our website. These are available at 'Adopted international technical guidance material—agricultural' and 'Adopted international technical guidance—veterinary' Two rounds of public consultation on our policy on the use of international standards, guidelines and decisions were undertaken in 2015–16, and implementation will be done in 2016–17	1.2.A
Participation in Global Joint Reviews (GJRs)	Completed: oxathiapiprolin and metacam Ongoing: bicyclopyrone, flupyradifurone and cyclaniliprole	1.2.B
100% of relevant international standards adopted for new chemical products and chemical review decisions	The APVMA is continuing to apply international standards in risk assessments undertaken for product applications and chemical reviews	1.2.C
Documented justification for the non-adoption of international standards and guidelines	There were no instances of non-adoption	1.2.D

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

PERFORMANCE INDICATOR: APVMA business processes are efficient and effective
Metric	Results	RPF reference
Satisfaction with APVMA online systems for submitting and managing applications	The APVMA conducted a useability review of online systems in 2015–16 to better understand client needs and to inform improvements to the user experience Recommendations from the review will be delivered and prioritised in 2016–17	1.3.A
Regulatory decisions are completed within timeframes	The APVMA publishes quarterly performance statistics on regulatory decisions. See 'Performance statistics'	1.3.B
Average decision time for applications by item	Average decision time for applications: products, 5.2 months actives, 8.8 months permits, 3.7 months	1.3.C

Average decision time

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

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

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

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

Analysis of time to complete a product application

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

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

Two aspects of performance were considered:

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

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

if the same methodology used today was applied to applications prior to 2014, the proportion of applications finalised on time would drop from 91 per cent to 33 per cent. (The APVMA has averaged 69 per cent since 2014)
the actual (or 'elapsed') time the APVMA takes to finalise applications has decreased by 70% since before 2014.

Table 11: Analysis of time to complete a product application
?	1 July 2011 –? 30 June 2014	1 July 2014 –? 31 March 2016
Proportion finalised on time (timeframe performance)
'Clock time'	91%	-
'Elapsed time'	33%	69%
Average time to finalise from lodgement
'Clock time'	3.1 months	-
'Elapsed time'	7.8 months	4.6 months
Number of applications processed	7941	1806

Communication

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

PERFORMANCE INDICATOR: Level of satisfaction with information and guidance materials
Metric	Results	RPF reference
Feedback from stakeholders about the quality of guidance material	There is a feedback mechanism on every web page containing guidance material All feedback is assessed and referred to business owners for action A useability review will be completed in 2016–17 and recommendations will inform further improvement to guidance material	2.1.A
100% of website content is reviewed by the nominated review date	Individual pages and sections of our website were updated as required A content management system is in place and full automation to prompt business owners to review content will be operational in early 2016–17	2.1.B
Usage of APVMA website	There were approximately 180 000 unique visitors to the APVMA website in 2015–16 and almost 2 million hits on the chemicals database	2.1.C
Number of subscribers to the APVMA?regulatory update	Almost 3000 subscribers are receiving the?APVMA regulatory update?by email	2.1.D
Website meets relevant Australian Government online and accessibility standards	An online usability review conducted in June 2016 confirmed that the?APVMA website?is substantially compliant with Australian government online and accessibility standards	2.1.E

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

PERFORMANCE INDICATOR: Level of satisfaction with the quality and timeliness of advice on decisions
Metric	Results	RPF reference
Feedback about the quality of pre-application assistance	Of the voluntary feedback received on the pre-application assistance process: 90% of applicants were satisfied with the clarity of advice provided	2.2.A
Customer service? standards met	The APVMA enquiries team received around 10 000 calls and 12 000 emails in 2015–16 The APVMA implemented a help desk tool in 2015–16 to enable tracking and monitoring of email enquiries. The tracking tool provides the status of each enquiry and monitors response times against the service standards Phone messages were checked daily by the enquiries team and return calls were made within the one-day standard An account manager model will be implemented in 2016–17 to further improve customer standards	2.2.B
100% of correspondence provided to applicants and registrants assessed as comprehensive and easily understood	A correspondence improvement project began in 2015–16 with a full audit of all outgoing letters, notices and emails Feedback from multiple sources and the recent useablity review confirms there is significant scope for improvement, and has identified priority products for action Implementation of improved correspondence products will commence in 2016–17	2.2.C

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

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

PERFORMANCE INDICATOR: Extent and satisfaction with APVMA consultative processes
Metric	Results	RPF reference
100% of new or major changes to operational policies or guidelines provided to relevant stakeholders for consultation prior to finalisation	The APVMA consulted on all major changes to operational policy and guidelines prior to finalisation	2.3.A
Feedback from key industry stakeholders about the quality of significant APVMA consultation	There is an opportunity for feedback to be provided during all public consultations as part of the submission process Feedback can also be provided generally via the website and in response to targeted consultation and industry meetings The APVMA did not receive concerns about the quality of consultation on major changes that were the subject of public consultation in 2015–16	2.3.B

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

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

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

Approaches to regulatory risk

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

PERFORMANCE INDICATOR: Risk management frameworks and policies are in place and regularly assessed
Metric	Results	RPF reference
Documented compliance and enforcement strategy, including options for graduated compliance,? in place	The compliance and enforcement strategy, which is underpinned by a risk-based approach is available under 'Corporate documents'	3.1.B
Risk frameworks reviewed every three years	The APVMA undertakes continuous improvement of its risk frameworks	3.1.C
Risk framework applied to registration decision and made accessible to regulated entities*	A conceptual risk assessment framework was developed in December 2015 and discussed with industry at APVMA-run industry sessions In consultation with industry, the APVMA will undertake a staged implementation of the framework	3.1.A

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

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

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

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

PERFORMANCE INDICATOR: Lower regulatory effort is applied to activities of lower regulatory risk
Metric	Results	RPF reference
100% of applications assessed as low regulatory risk processed according to risk-based assessment framework tools and mechanisms	The APVMA is continuing to explore alternative regulatory mechanisms and processes to reduce regulatory burden on industry	3.2.A
Documented approaches in place to review level of regulatory effort applied to agvet chemical registration and approval	Reports and progress updates for the lower regulatory approaches to registration project are available at 'Lower regulatory approaches to registration'	3.2.B