Transcript ECPA EffEG Pre-conference Efficacy 11th March 2015

Why haven’t we achieved efficacy
harmonisation?
Peter Schlotter
On behalf of ECPA-EffEG
Crop Protection European
Regulatory Conference –
Pre-conference Workshop Efficacy
submission in the EU,
Brussels 11th March 2015
COMPLEXITY in the EU!
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Why haven’t we achieved efficacy
harmonisation?
Introduction and Zonal Process
Barriers of harmonisation
Approaches taken toward harmonisation
under 1107/2009
– Areas for improvements
– Remaining challenges
Way forward: recommendations for
harmonisation by ECPA-EffEG
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THE COMPLEX ZONAL PROCESS –
Registration of products
• All pesticide products must be registered in a country before
they can be advertised, sold or used
 Following Annex I Inclusion (91/414) or Approval (1107/2009) of the active
substance the product must be (re)-registered
• Before 91/414 (1993): registration acc. national laws in all 28
countries
– Last Annex Is under 91/414 were 2011 = many products in Europe
registered under old national rules
• 91/414 Introduction of mutual recognition and voluntary
worksharing (came in gradually). dRR format concept started
– Efficacy driven by BAD within MSs, other sections already EU or Zonal
processes
• 1107/2009 (06/2011) Zonal process with 3 Administration Zones
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THE COMPLEX Zonal Process
– The Zones
• North (6)
– Denmark, Estonia, Latvia, Lithuania, Finland, Sweden
• Central (13)
– Belgium, Czech Republic, Germany, Ireland, Luxembourg,
Hungary, Netherlands, Austria, Poland, Romania, Slovenia,
Slovakia, United Kingdom
• South (9)
– Bulgaria, Greece, Spain, France, Italy, Cyprus, Malta, Portugal,
Croatia
• Protected uses and seedtreatment
– All zones
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Biological development in Europe
(Administrative vs EPPO zones)
FIN
SWE
EST
Northern- 6 MS
LVA
2 EPPO Zone
DNK
LIT
IRL
GBR
NLD
POL
Central – 13 MS
BEL
GER
LUX3 EPPO Zone
CZE
SVK
FRA
AUT
HUN
SVN
PRT
ESP
ITA
Southern- 9 MS
3 EPPO Zone
ROU
BGR
GRC
MLT
CYP
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European map with defined geographic regions: 4 EPPO Climatic
Zones (in colour) and 3 European Administration Zones
Kroatien
Note: Indoor use = one
Administration Zone
Trend for more systematic use of PP1/241 in designing, implementing and reporting
on trial programs. Trials placed according to relative importance within EPPO zones.
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Barriers of harmonisation
Complex Process and Zonal structure
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Barriers of harmonisation 1
Complex Process and Zonal structure
– Implementation of Administrative and EPPO Zones
– Central Zone most critical Zone with 3 EPPO Zones (diversity)
– Southern Zone with 3 EPPO Zones (France and Croatia with 2)
– Communication within the Zone – Language is a barrier
• 28 countries with 24 official languages (linguistic diversity)
– Expansion of European Union to 28 countries
• 2004: CY, CZ, EE, HU, LV, LT, MT, PL, Sl and SK
• 2007: BU and RO
• 2013: HR
• 13 MSs joined EU more than a decade after 91/414
– National registrations and requirements
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Barriers of harmonisation 2
Complex Process and Zonal structure
– EPPO and Guidelines Documents (GD)
•
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
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Barriers of harmonisation 3
Complex Process and Zonal structure
– EPPO PP1/226
• Definition of major crops, minor
uses and minor crop
crops, major
• Minor uses not adapted to Zonal context
– GEP certification + Certificates
• Not all institutes are GEP certified (also Official Institutes !)
– Harmonisation of GAPs
– Dose rate expression in 3 D crops
– Authorities and efficacy evaluators
• Workload
• Diverse knowledge of efficacy evaluators within countries and Zone
• Level of participation of evaluators in committees and conferences
• Lack of trust leading to repeating evaluation
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– Approaches taken towards
harmonisation under 1107/2009
– Areas for improvements
– Remaining challenges
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Approaches taken towards
harmonisation under 1107/2009: dRR
• Part A – National Risk Management
• Part B - Core assessment for the zone
– Section 1 - identity, phys-chem, further info
– Section 2 – methods
– Section 3 – tox
– Section 4 – residues
– Section 5 – EFate
– Section 6 – Ecotox
– Section 7 – Efficacy will become section 3 (Beginning 2016)
– National addenda to any section 1-7
• Part C – Confidential
• Parts A and B may be released to 3rd parties after authorisation! 13
Relationship between draft Registration Report
(dRR) and zonal BAD (Part B, section 7 new 3)
Process to transform documents of the efficacy package into a registration report (RR).
Source:
Technical Guidance Paper dRR
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Approaches taken towards
harmonisation under 1107/2009
– The Zonal BAD is a detailed analysis of the overall trial work
which considers the PPP in relation to its benefits and risks
within a specific Administrative zone
• It’s a complex dossier
• The Zonal BAD can cover many countries & situations
• It can cover a multitude of uses (crops, targets) with
possibly different GAPs
– The Zonal dRR is considered a stand-alone concise summary
of the Zonal BAD
• It is a sizeable summarization of the relevant zonal
information
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Approaches taken towards harmonisation
under 1107/2009: New dRR table of content
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Approaches taken towards harmonisation
under 1107/2009: New dRR
Finalisation of a new dRR format for future submissions:
– The new dRR will be named as Section 3 and contain a new and
more organised Table of Content
• Improved clarity of the different chapters of the dossier
• Benefits are presented followed by the potential risks of the PPP to:
– The crop
– Other parts than the crop
– Chapter 3.0 is added at the beginning to report on the summary &
conclusion from the zRMS associated to a GAP table with
recommendations
– Commenting boxes seen valuable as soon as initial dRR is a good
document
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Areas for improvements:
The EPPO standards
Conducting the needed experimentation and reporting of the data
under a dossier format is to be done following EPPO standards:
– A set of general standards (26) and efficacy standards (>200) is available
– New additional standards are under preparation to complete the needs
 This allows using a common language,
 that is deemed to follow the Uniform Principles and,
 should facilitate possible Mutual Recognitions,
 within and between Administrative Zones.
 But we see real differences in the use and interpretation of
the guidelines
 Need to adjust the EPPOs to the Zonal process, PP1/226...
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Areas for improvements:
The GEP certification
GEP accredited organisations are allowed to conduct
experimentation that is needed for a submission for registration
Few exceptions are accepted:
 Official Scientific Institutes are sometimes not GEP.
 For historical reasons, reports from experimentation conducted in
countries prior to GEP implementation can be used and should be
accepted.
GEP certificates from the Testing Organisations are submitted
together with the Biology Assessment Dossier.
GEP certificates are documents under diverse formats and in local
languages. To ease the use of these documents, ECPA has created
an internet database that collects these documents.
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EU GEP Certificate Database
developed by ECPA EffEG
Currently 1185 certificates, 675 organisations and 427 registered users
across EU
Entry of new certificates is checked to avoid duplication of certificates
No limitation on access to the database – evaluators do not need to be
registered users
Open to applicants, regulators, official testing organisations - visible to all
A table containing a list of certificates with hyperlinks to certificates,
can be downloaded and copied/pasted into dossiers – no need to
insert paper copies of certificates – not accepted by all MS
www.gepcertibase.eu
BE project to develop a standardized format following the ECPA proposal
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Areas for improvements:
The studies (Trials,…)
– Trials should be implemented under GEP accreditation (where
established)
– Trials should be conducted according to EPPO standards
• According to the general standards PP1/152, PP1/135, PP1/181,
PP1/225,…
• As well as specific efficacy standards (PP1/XXX)
– Trial reports should be of good quality
• It is recognised that format of trial reports is varied with increasing use of
electronic data capture
• Flexibility by MS of acceptance of old data reports and trial format
• New trial reports will comply with PP1/181
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Remaining challenges:
Trial requirements
:
From Official documentations:
– EPPO PP1/226 (major pest on major crop, major pest in protected
conditions, minor use)
– Northern Zone Guidance document with major crops as appendix
• good example of MS working together (authorities and industry)
– National requirements (IT, IR, GR, FR, SK...).
Risk of adding complexity to be considered while producing
additional documents/requirements
 Need for revision of PP1/226 within the frame of Zonal
development
 Can we get harmonisation without National requirements?
 Establishment of a Zonal working group or round table (e.g.
Northern Zone)?
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Areas for improvements:
National guidance documents
• Ireland 2013: Guideline Requirements for Irish based trials on wet
weather fungal diseases for Efficacy Submissions in the Biological
Dossier to PRCD in relation to the authorisation of a PPP.
• Slovakia 1/2014 (UKSUP): Metodicky pokyn
•
Number of trials to be submitted in SK
• France: CEB, Document technique N° 23, Recommandations pour
une surveillance de la résistance aux fongicides en vigne
• Greece 2013: National guidelines, Supplementary to EPPO
Standards, Appendix II and III
• Italy 2015: Studi di efficacia e selettività necessari revisione
Ferrero_1.proporta
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Remaining challenges:
Minor uses
Within the submission of a Zonal dossier it looks more efficient to
claim for Minor uses across countries despite minor uses are still
under National regulation
– Status of minor crops differ in different countries
– Group of targets: some countries authorize pest group, others single
pests
Efficacy – different interpretations from Authorities make the Zonal
submission critical
What about the value of the EUMUDA database?
Can we seek for common principles?
Revisit the Extrapolation guidelines
frame of Zonal development?
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within the
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Remaining challenges:
Re-registration article 43 of 1107/2009
Will become the highest workload for both applicants + authorities
in the next 3-4 years.
Only a light dRR (no BAD) is needed with following assumptions*:
– GAPs remained unchanged
– No new uses ! No new MS! No formulation change!
Update the following items:
– Overview of the country registrations and uses and the GAP
– Update Resistance section
– No new efficacy trials to be submitted
Agreement is valid for CZ submissions
This process is not yet agreed for SZ
*C. Prohaska, Head of AGES: Informa meeting, Berlin Feb . 2015
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Remaining challenges:
Dose rate expression and standardization
Dose rate expression in 3D crops is progressing: the LWA concept
– Key benefits:
•
Single and scientifically more accurate dose rate expression across Europe
•
Applicable for wall-shaped canopy crops
•
Experienced and agreed by Companies through Working Group activities
– Agreed for experimentation for pome fruit trees
– Under progress for stone fruit trees and high growing vegetables
– Under evaluation for grapes
BE has already introduced LWA in 3 D crops
DE is planning the introduction in grapes 2016
AT is supporting LWA concept
Harmonisation in Europe and in the Zone is needed
–
Acceptance of previous trials and data sets
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ECPA Efficacy Expert Group
Way forward:
Recommendations for harmonisation
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ECPA EffEG
Recommendations for harmonisation
• Improve level of trust
• Communication and cooperation within MS evaluators and industries
and within the Zones
– Develop pragmatic (Zonal) approaches that have a wide
acceptance from MS and industry (round tables, workshops…)
– Example Northern Zone guidance on efficacy
• More flexibility by MSs in regard of acceptance of old data or previous
registrations without submission of new data
• Improve Zonal harmonization in the evaluation
– Stop specific national requirements
– Development of harmonized Zonal documents
– Light dRR for re-registration for all Zones (article 43 of 1107/2009)
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ECPA EffEG
Recommendations for harmonisation
• Implementation and use of the new dRR template
• Communication zMS evaluators and industry – e.g. pre-submission
and follow up meetings
• Improve Zonal process – time and re-evaluation by cMS after Zonal
approval by zRMS
• Field trial report format + quality – acceptance of older reports and
format for re-registration
• Use of GEP certificate database
• Follow guidance documents and use of EPPO standards
– Revision of EPPO 226: Number of trials for major and minor use –
(linkage 226-278-241, better definition of minor uses)
• Zonal harmonization of expression rates for 3 D crops
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Why haven’t we achieved efficacy
harmonisation?
Complexity …
Improvements achieved
Promotion of harmonisation is needed among
all stakeholders in the future
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Thank you
Peter Schlotter on behalf of ECPA EffEG
Office: +49 45533126;
Mobile: +49 171 2445705;
[email protected]
Dow AgroSciences GmbH
Truderingerstr. 15
D-81677 Munich