Industry Overview on Key Zonal Challenges

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

2. Overview of the Presentation • 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

3. Industry Hopes for Zonal Evaluation Registration of new formulations in 12 (18) months and MR in 120 days!

4. Feedback from the ECPA Survey • 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

5. Progress of submissions made under 1107/2009 For submissions made between June 2011 and December 2012 • 12 companies responded • Representing 75% of the EU market • 177 submissions were made • 58 decisions taken to date

6. Progress of submissions made under 1107/2009 Overview of time taken to decision • Average time reported: 15.2 months – but 119 still pending!

7. Progress of submissions made under 1107/2009Decision Time Taken by Zone

8. Progress of submissions made under 1107/2009 Decision Time Taken by Submission date

9. Progress of submissions made under 1107/2009 Qualitative Feedback on Key Issues

10. MR submissions made under Regulation 1107/2009 between June 2011 and September 2013 • 12 companies responded • 369 applications • 177 decisions taken to date

11. MR submissions made under Regulation 1107/2009 between June 2011 and September 2013 • Average time to decision: 9.6 months but 192 still pending!

12. MR submissions made under Regulation 1107/2009 between June 2011 and September 2013 • Average time to decision by Zone

13. Mutual recognition submissions Qualitative Feedback on Key Issues

14. ECPA Model for PR Workload Prediction 2016-2018 >10,000 PR submissions! • 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

15. MS Capacity 2015

16. What has been Achieved So Far? • 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

17. The Key Outstanding Issues to be Resolved • 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

18. Resources • 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

19. Harmonisation • 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

20. Increased Zonal and Interzonal Co-operation • 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

21. dRR Quality • 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?

22. Article 43 • 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

23. ECPA Proposal for a Way Forwards • 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

24. Industry Hopes for Zonal Evaluation Zonal needs to work! ECPA still want to make zonal work!

25. Conclusions • 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