ECPA launches Technical guidance paper for EU efficacy submissions
Guidance Paper to support the completion of draft Registration Reports (dRR) now online
The European Crop Protection Association (ECPA) has today launched a Technical Guidance Paper for applicants in preparing a detailed efficacy summary as part of a draft Registration Report (dRR).
The Technical Guidance Paper (TGP) has been developed to ensure common standards that can be used by industry to provide submissions that are more standardised across the EU.
To date there has been limited guidance available on the efficacy summary submissions that have to be submitted with the draft Registration Report (dRR). It is hoped that the ECPA TGP will provide a common standard that will be helpful for both applicants and evaluators, being particularly important with the introduction of the zonal product authorisation process recently introduced with Regulation 1107/2009.
“This guidance will help industry to develop standardised submissions. We also hope that such standardisation will simplify the evaluation process of the national authorities, while at the same time improving information exchange between these authorities. We hope to gain experience with the current TGP and we would expect certain improvements to be made to further assist the submission and evaluation processes”. said Patrice Duvert, Chairman of ECPA’s Efficacy expert Group.
Euros Jones, ECPA Regulatory Affairs Director added, “This is the first such Technical Guidance Paper but given the numerous new requirements in Regulation 1107/2009, we are currently discussing further TGPs which we hope will support industry in ensuring standardised compliance with the provisions of the new Regulation."
Note:
The Technical Guidance Paper is available at:
www.ecpa.eu/information-page/regulatory-affairs/technical-guidance-papers
