focus on biological dossier and cooperation in the southern zone laurent thibault and véronique...

Focus on biological dossier and

cooperation in the Southern zone

Laurent Thibault and Véronique MironetAnses - Efficacy Evaluation Unit for plant protection products and fertilisers

1/17ECCA & ECPA – Crop Protection European Regulatory Conference - Efficacy Pre-conference

Workshop Brussels - 11 March 2015

Overview

Issues with dossiers submitted and recommandations

Cooperation between experts involved in biological efficacy

New format for the dRR template

Conclusion

ECCA & ECPA – Crop Protection European Regulatory Conference - Efficacy Pre-conference Workshop Brussels - 11 March 2015

2/17

Zonal level increase the complexity of dossiers and the evaluation

process

Need for a clear understanding of the intended uses (GAP) Between member states Including the major/minor uses

To avoid inconsistencies between the GAP tables of the different sections of the dRR, the content of the dossier and the national application form


3/17

1/4Issues with dossiers submitted and recommandations


Efficacy trials : Do the data (or the rationale) support all the intended

uses ?

Justify the absence of data : e.g. to propose extrapolation

Quantity is not quality : dRR should be more concise and standalone document Data not sufficiently summarized : put together ≠ sum up National addenda should be justified : specific use or

specific practices


4/17

2/4


In case of re-registration dossiers:

In principle, all uses are re-registrations

But if it is not this case, e.g. new use in zRMS then information should be given to zRMS : cMS where the product is registered

zRMS is not able to conclude for the whole zone if the information is missing

3/4


5/17

Zones and dossiers: Dossiers should be adapted to each regulatory zone. Trials should be distributed in the whole regulatory zone. EPPO climatic zone is not always the best solution to

sumarize trials (France is cut in two EPPO zone)


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To justify the distribution of trials

within the zone

4/4Issues with dossiers submitted and recommandations

Zonal evaluation avoids duplication of work : As cMS, we are able to rely on the RR produced

by other MS Save time and workload

Since June 2011 : Clear improvement of the quality of dRR received from

applicants Clear trend in reduction of « national requirements » in

the evaluation


7/17

1/3Cooperation between experts involved in biological efficacy

Cooperation between experts involved in biological efficacy

Exchanges on technical issues/interpretations should be improved between experts of MS of the southern zone

Currently, the most common ‘exchange’ : By commenting tables on dRR (zonal evaluation)

To share and to improve evaluation Transparency for MS and applicant

Proposal by Anses to organise a face to face meeting between experts of the southern zone involved in biological efficacy in 2015


8/17

2/3

Some Items for discussion in the face to face meeting e.g.:

Minimum effective dose : need to be justified ?

Distribution of trials / trial grouping

Relation between GAP, conditions of trials, acceptability of deviation

Trials : need for criteria to consider the trials valid or invalid ?


9/17

3/3Cooperation between experts involved in biological efficacy

New format for the dRR templateAnother example of cooperation


10/17

This work is a real way to share opinions of EU efficacy experts and to improve the cooperation between MS

This new format should avoid duplication of work for MS and applicants and save time

Leader of the Working group: BVL (Germany)

One subgroup for each section of the dRR

Chair of Efficacy subgroup : France

Context and Method

Members of the

efficacy subgroup

Chair: France (Anses)

Grece (BPI) UK (HSE) Germany (JKI) Netherlands (CTGB) Danemark (AGRSCI) Hungary (NEBIH)

ECPA

Calendar February 2012: Kick-off meeting July 2012: First version (FR) sent to subgroup for

comments March 2013: 2nd Braunschweig Meeting

(coordination ; point on all sections) November 2013: Face to face meeting – Paris

(subgroup) January 2014: Final version (from the subgroup)

sent to BVL May 2014: Presentation to ScoPAFF (SCFCAH =

CPCASA) and sent for comments to all MS (27) July 2014: Comments back in France October 2014: Final version and reporting table,

sent to BVL December 2014: Presentation to ScoPAFF (With

new reformatting from BVL and accompanying documents from HSE (UK). Sending for comments to all MS (27)

February 2014: Last final version and reporting table, sent to BVL

March 2014: Final presentation to ScoPAFF ??


11/17

Some outcomes : table of contentsCurrent chaptering

Efficacy data … Effects on yield and

quality Effect on yield Effect on quality Effects on transformation

processes…

Adverse effects Phytotoxicity to host crop ... Propagation Succeeding crops Adjacent crops Resistance

New chaptering proposed(according to regulation 284, except

MED) Efficacy data

Resistance

Adverse effects on treated crops Phytotoxicity to host crop Effects on yield Effects on quality Effects on transformation

processes Propagation

Observations on other undesirable or unintended side-effects Succeeding crops Adjacent crops …


12/17

Some outcomes

MS approaches when transforming a dRR into a RR: Deleting / rewriting Use of commenting boxes The chosen option(s) should be explained at the beginning

of the RR

Use of summary tables as much as possible, instead of text: in the template, examples of tables (with possibilities of

modification) are proposed


13/17

Conclusion

Issues with dossiers submitted and recommandation

Avoid overall dossiers for all zones

Importance of adapting the dossier to the regulatory zone concerned

Clear improvement of the quality of dRR received from applicants

Still need to reduce the size of dRR (without reducing the quality)


14/17

Conclusion

Cooperation in the Southern zone

So far : main exchanges by commenting tables on dRR

Need to improve communication and have face to face meeting between efficacy evaluators of the southern zone: To share experiences To discuss and solve remaining technical open points


15/17

Conclusion

dRR template : A real way to share opinions of EU efficacy evaluators An exemplary democratic process: With its advantages: a collective document with high

quality And its defects:

3 years of work An infinity of comments in an infinity of round trip of comments

tables Always new comments of the same members of subgroup,

despite the accepted modifications and a face to face meeting …☺

Next step planned: validation of the template to SCOPAFF


16/17

Thank you for your attention

[email protected]@anses.fr


17/17

focus on biological dossier and cooperation in the southern zone laurent thibault and véronique...

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