Feedback from the efficacy workshop – lessons learnt and future challenges Steve Dobson

…..or I also have a dream

What I want to say and what you want to hear All zones have clear guidance and consider there is little need for national guidance documents Exception levels of trust exist amongst Member States and their efficacy specialists Communication lines are clear and transparent EPPO Guidance is interpreted in the same way by Member States Authorities consider BADs and dRRs to be consistently of high quality with industry making clear summaries of the BAD in the dRR Flexibility, pragmatism and consistency are key principles used by Member States when considering Article 43 submissions

Zonal complexity – EPPO zones vs administrative zones Northern- 6 MS 2 EPPO Zone DNK SWE FIN LIT LVA EST GBR FRA IRL BEL NLD GER CZE SVK HUN ROU AUT POL ESP PRT GRC MLT ITA BGR LUX SVN CYP Southern- 9 MS 3 EPPO Zone Central – 13 MS 3 EPPO Zone

Need for consistency of approach EPPO and Guidelines Documents (GD) Different interpretation of guidelines Not all MSs are following EPPOs and GDs dRR and BAD No agreed zonal standard or template available Misunderstanding content and role of BAD and dRR Efficacy the only section with 2 dossiers + single field trial reports Trials and trial reporting and quality Acceptance of old data reports and country registrations Data requirements - Number of trials required EPPO PP1/226, but also national guidelines (IT, IR, GR, SK,…) DE – number of trials on each BL weed species required Various requirements without considering EU expansion

For applicants to consider Is there clear information on relevant product history? Do the data support all the intended uses? Is there consistency between documents on proposed use? Have you explained any differences in proposals between cMS – specific uses or practices? Is the validity of reference products used clear? Are trials in the BAD organized so that it is straighforward to track single trials? Is the dRR a summary of the BAD (around 20 to 30 pages) and not just a copy? Quantity is not quality.

Article 43 renewal of authorisations Concern on workload Need for agreement on approach – Central Zone approach: If the GAP is unchanged and no new uses/MS/formulation changes – only a light dRR (no BAD) required Update overview of registrations and uses Updates resistance section No new trials to be submitted

Improving the process SANCO/10055/2013 guidance on core dossier and National addenda Need for pragmatic (zonal) approaches that have wide acceptance Northern Zone guidance on efficacy – example of clear zonal guidance New dRR format – March ScoPAFF Project to update BAD guidance to start soon (Be, Fr, De, NL, DK and UK) – need for input from more recent MSs identified A project is underway to share information on GEP auditing and processes Proposal to identify examples of ‘what good looks like’

Improved dRR

Conclusion TRUST is essential if MS shall accept evaluations from other MS COMMUNICATION is necessary to harmonise requirements INFORMATION EXCHANGE on zonal affairs is essential for making zonal evaluations TRANSPARENCY facilitates a common understanding and good atmosphere between industry and evaluators