Kerry Gamble, Syngenta CP, Basel ECPA-ECCA Conference, 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 –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

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

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

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

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

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

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

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

Mutual recognition submissions Qualitative Feedback on Key Issues Examples of Problems EncounteredComments Reference MS in different zoneArticle 40 Mutual recognition not granted for 91/414 registrationsCOM Confirmation Different national requirementsHarmonisation Did not receive registration reportZonal 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 >10,000 PR submissions!

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 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