Kerry Gamble, Syngenta CP, Basel ECPA-ECCA Conference, 12-13 March, Brussels Industry Overview on...

Kerry Gamble, Syngenta CP, Basel

ECPA-ECCA Conference, 12-13 March, Brussels

Industry Overview on Key Zonal Challenges

Share the Industry hopes for zonal evaluation

Present the feedback from the ECPA survey

Reflect on what has been achieved so far?

Look at the key outstanding issues still to be resolved

Make an ECPA proposal for the way forwards

Conclusions

Overview of the Presentation

Industry Hopes for Zonal Evaluation

Registration of new formulations in 12 (18) months and MR in 120 days!

– Analysis of zRMS timelines for new formulations

– Qualitative feedback on the key issues

– Analysis of timelines for mutual recognition applications

– Qualitative feedback on the key issues

– ECPA model for PR workload prediction for 2015-2018

– Capacity of MSs for zonal submissions

Feedback from the ECPA Survey

12 companies responded

Representing 75% of the EU market

177 submissions were made

58 decisions taken to date

Progress of submissions made under 1107/2009

For submissions made between June 2011 and December 2012

22

79

76

Total of 177 zRMS Dossiers Submittedfor New Formulations

North Central South

Average time reported: 15.2 months – but 119 still pending!


Overview of time taken to decision

No. of Dossiers0

5

10

15

20

25

30

11

5

26

13

3

< 12 months12 months>12 and ≤ 18 months>18 and < 24 months≥ 24 months


Decision Time Taken by Zone

North Central South0

5

10

15

20

25

7

20

15

2

6

8

Decision ≤ 18 monthsDecision >18 months


Decision Time Taken by Submission date

Jun-Dec 2011 Jan-June 2012 July-Dec 20120

5

10

15

20

25

30

35

40

45

50

47

5

12 11

3

10

42

28

22

8

26

47

43

≤12 months≤18 months≤24 months>24 monthsDecidedStill pending


Qualitative Feedback on Key Issues

Examples of Problems Encountered Comments

Lack of resources Article 75(3)

Lack of capacity for zRMS applications Article 75 (3)

Evaluation on time but delay to official decision Article 37(1)

On-going dialogue to resolve technical questions Article 37(1)

Quality of dRRs Article 37(1)

Complex national processes (multiple Authorities) Article 37(1)

Waiting for confirmatory data (and EU evaluation of it) COM Confirmation

MR submissions made under Regulation 1107/2009

between June 2011 and September 2013

15

187167

Total Mutual Recognition Submissions

NorthCentralSouth

12 companies responded

369 applications

177 decisions taken to date

Average time to decision: 9.6 months but 192 still pending!



No. of Dossiers Decided0

10

20

30

40

50

60

70

80

44

74

49 ≤ 4 months

> 4 - ≤ 12 months

>12



North Central South0

5

10

15

20

25

30

35

40

6

22

16

6

34 34

1

29

19

≤ 4 months

4 ≤ 12 months

< 12 months

Average time to decision by Zone

Mutual recognition submissions Qualitative Feedback on Key Issues

Examples of Problems Encountered Comments

Reference MS in different zone Article 40

Mutual recognition not granted for 91/414 registrations COM Confirmation

Different national requirements Harmonisation

Did not receive registration report Zonal Helpdesk

PR workload for AIR3 AIs (146)

Assume each AI is registered in 9 products in 7 countries

Submissions planned for 3 months after AIR3 AI EIF

Mixture products counted for each active separately

Only submissions from main notifier counted

ECPA Model for PR Workload Prediction 2016-2018

>10,000 PR submissions!

2016 2017 20180

1000

2000

3000

4000

5000

6000

ProductsSubmissions

AT BE CZ DE HU NL PL SI SK DK LT LV CRO ES GR IT MT PT0

5

10

15

20

25

30

35

40

45

50

55

60

65

New Formulations Re-Registrations

MS Capacity 2015

North Zone– North Zone Guidance and established ways of working

– Workshops between Industry and Authority – transparency and collaboration

South Zone– Established ways of working

– Agreed how to manage north zone residue data for applications including FR

– Improvements in resourcing (fees to agencies)

Central Zone– UK CRD harmonisation initiatives

– NL Ctgb Tour of Directors

– CZSC list of agreements

– Increase in resources in some countries

– Review of working practices between MSs (pilots)

Interzonal– dRR Workgroup could improve harmonisation

– Post Approval Issues Group – facilitating ways of working across EU

– Indications of increased willingess to mutually recognise in some countries

What has been Achieved So Far?

– Increase resources to meet the demands of the regulation

– Remove the national requirements (technical and procedural)

– Increase zonal and interzonal co-operation

• Zonal Helpdesks to co-ordinate the work and improve efficiency

– dRR quality

– Reconsideration of Article 43

The Key Outstanding Issues to be Resolved

– Insufficient resources exist to deliver the demands of 1107.....

• Zonal process and timelines

• AI processes

• Comparative assessment

• Product renewal evaluations

– Article 75(3) requires MSs to ensure Authorities have sufficient resources

– Productivity gains would minimise the need for additional resources

– However, productivity gains alone are unlikely to manage the demands of the forthcoming workload from Article 43

Resources

– Lack of harmonisation within and across zones (even within zRMS)

• Technical national requirements including mitigation

• Procedural national requirements

• Adoption of different guidance documents at different timepoints

• Different interpretation of the same guidance

• Use of different endpoints than those established at EU level

– Creates complexity

– Prevents effective work-sharing

– Creates additional work for industry, zRMS and cMSs

– Causes delays

– Harmonisation is needed if zonal evaluation and mutual recognition are going to work

Harmonisation

– Productivity gains will only be achieved through improved zonal and interzonal co-operation

– ECPA recommend a zonal and interzonal helpdesk to:

• Facilitate the work sharing

• Facilitate the ways of working

• Improve harmonisation

• Lead the change

Increased Zonal and Interzonal Co-operation

– Key message to industry is that excellence in dossier quality will support a smooth process and assist Authorities in meeting timelines

– In such a complex and uncertain regulatory environment and with long lead times to dossier production, Industry feel that they are trying to hit a moving target

– Quality needs definition – content, format, structure

– Expectations between MSs and with industry are not always the same – Industry need one agreed understanding of what this means

– Is a working group on dossier quality needed to ensure applicants know what is needed? Is this within the remit of the dRR Workgroup?

dRR Quality

– Current assumptions

• 3 months from AI EIF to PR Submission

• As complete a dossier as possible should be submitted

• Top up possible for data needed and out of applicants control

• Submission after every AI EIF in mixture products

• 6 months evaluation for zRMS and 3 months for cMSs

– Consequences

• Huge workload (10,000 submissions between 2016 and 2018)

• Living dRRs subject to constant change and re-writing

• Unmanageable timelines for Industry and Authorities

– Current COM Guidance on Renewal and Withdrawal does not solve these issues

– An urgent amendment of Article 43 is needed

Article 43

– All these problems are well known

• Re-read the presentations from ECPA Conference in Malta in Nov 12, Informa in Brussels in Apr 13, Ag Chem Forum in Brussels in Sep 13

• All Industry and Authority presentations have lots of ideas and talk about a willingness to make zonal work and yet it’s still not working

• The zonal and mutual recognition timelines in 1107 are not being met

• Delays in zRMSs are causing delays in cMSs

• Zonal has increased the complexity

– ECPA urgently propose

• Leadership and governance from the Commission

• Work with Chairs of ZSCs + iZSC (or PAIG?)

• Involve ECPA & ECCA & IBMA as relevant to find solutions

• Develop strategy, milestone plan and agreed actions with defined timelines

ECPA Proposal for a Way Forwards

Industry Hopes for Zonal Evaluation

Zonal needs to work! ECPA still want to make zonal work!

Industry had high hopes for zonal and mutual recognition

ECPA survey shows that neither are working according to the 1107 timelines and expectations

Some improvements are visible and there seems to be a willingness from Authorities to make it work

A number of key issues still need to be resolved:

– Resources

– Harmonisation of the national requirements

– Interzonal and zonal co-operation (facilitated by Zonal Helpdesks)

– dRR quality

– Article 43

ECPA propose that COM lead the way forwards to develop a strategy, milestone and action plan

Conclusions

Kerry Gamble, Syngenta CP, Basel ECPA-ECCA Conference, 12-13 March, Brussels Industry Overview on...

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