ECPA Experience of the Zonal Process South Zone Steering Committee - PowerPoint PPT Presentation

ECPA Experience of the Zonal Process South Zone Steering Committee Kerry Gamble, July 10th 2015

Content ECPA Key Messages Feedback from the Dublin Workshop How can we help? Conclusions 2

Introduction PPP Regulation is designed to ensure a high level of protection of both human and animal health and the environment...; while improving agricultural production EU South zone is a very important agricultural area with a large diversity of crops (major and minor) and very demanding cropping tools Key objective is to bring new innovation to the market Renewal of active substances and products is a requirement of 1107/2009 but it should not hinder the introduction of new active substances and products Renewal SANTE GD generates work duplication generating two different processes going in parallel: article 43 and Article 33. No use of risk envelope approach for overall evaluation

ECPA Key Messages Work together to share understanding and solve the problems – Set clear strategic direction and govern the implementation – Drive harmonisation – technical and procedural – Establish trust and good communication between Authorities and evaluators – Ensure manageable and consistent implementation of Article 43 – Create shared external quality standards for submissions – Develop a change management process for the implementation of new guidance – Provide a resourced and prioritised plan of work – Increase zonal and interzonal co-operation – Establish the helpdesks to facilitate the process

Dublin Workshop Key Conclusions Key Conclusions from the Workshop: Address national specific requirements and harmonisation  – Take note of Article 43 GD asap and make sure it is applied afterwards  – Dossiers and registration reports must be fit for purpose  – Preparation and implementation of (technical) guidance documents  – Support mutual recognition working  – Evaluate Interzonal worksharing  – Establish the Zonal Secretariat  –

How can we contribute?

How can we help? Harmonised Implementation of Article 43 Interzonal Worksharing Pilots dRR Quality Workgroup Mutual Recognition Strategy Measuring Performance of the Process

Harmonised Implementation of Article 43 Background Renewal guidance document is anticipated to be noted July 13/14 2015 – Industry welcome the COM proposal to extend the expiry date for 23 AIR2 AIs – However, due to the uncertainty with timelines and requirements, industry have already started work on document and dossier production – The Renewal GD does not provide sufficient detail to enable a uniform implementation by applicants and Authorities – Industry have therefore prepared a detailed list of outstanding questions which need to be answered to provide applicants with the level of detail needed to prepare PR submissions – Industry strongly advocate for a harmonised approach by Authorities to avoid complexity and minimise duplication of effort by industry and Authorities Action MS Authority feedback on zRMS allocation is urgently needed MS Authority feedback on a ‘standard’ set of answers to procedural questions is also urgently requested.

Harmonised Implementation of Article 43 ECPA have prepared a survey for MS Authority feedback on the ‘standard’ set of procedural questions • ECPA propose to send this to: – COM – PAIG (directed to Darren Flynn) – Chairs and Co-chairs of Zonal Steering Committees • Aiming for harmonisation • But industry also need to urgently understand if there are zRMS specific preferences ECPA would also like to offer to design proformas and templates to be shared with COM, ZSCs and PAI (iZSC) to standardise what will need to be provided by industry at the PR deadline

Interzonal Worksharing Pilots ECPA welcome the action from the Dublin Workshop to identify projects as Interzonal worksharing pilots – These pilots also provide the opportunity to work together further on : • The relationship between protected uses and interzonal worksharing • Harmonisation proposals (technical and procedural) • Core dossier and addenda concept to enable interzonal worksharing • Setting external quality standards • Support with remit of Zonal Helpdesk and potential funding opportunities • Implementation and future development of the PPP Database This would address the proposal for a pilot interzonal evaluation, from the South Zone Directors meeting on 17 November 2014

dRR Quality Workgroup – 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 and evaluation, Industry feel that they are trying to hit a moving target – Quality needs common definition – content, format, structure • The new dRR Templates are the first step in this process – Expectations between MSs and with industry are not always the same – Industry need one agreed understanding of what this means – ECPA propose a meeting with PAIG to discuss further with a view to establishing a joint workgroup on this critical topic

Mutual Recognition ECPA fully support the proposal that a full evaluation should not be conducted by the MS which receives the MR application – Therefore there should not be a need to challenge the way the evaluation has been conducted by the reference MS as it was done under EU requirements However, a completeness check should be conducted And data protection principles should be fully respected which means that during the data protection period for a specific product: – The applicant must be the owner of the protected data which is the basis of the registration in the reference MS or – A Letter of Access to the protected data is required or – The data should be submitted with the application for mutual recognition Availability of a reference list of studies for registered products is important to have in order that the data protection compliance step can take place ECPA fully support the creation of a database of the data protection status of all data in all MSs

Measuring the Performance of the Process ECPA have previously shared statistics on performance of process for zRMS Zonal timelines and Mutual Recognition timelines – Authorisation of new formulations in 12 months, and the mutual recognition of existing authorisations in 4 months, can be achieved......... but the majority take longer – And a high percentage remain pending (50%); many zRMS authorisations for longer than 18 months and mutual recognition for longer than 4 months The ECPA data has not been validated by Authorities How can we create a process for measuring performance to enable a benchmark to be set and improvements to be measured?

Conclusions Industry are really pleased with the directional alignment between Industry and Authorities in terms of the key initiatives needed to achieve success with the implementation of Zonal, Mutual Recognition and Article 43! ECPA would like to offer to support the next steps with: – A harmonised implementation of Article 43 – Interzonal Worksharing Pilots – dRR Quality Workgroup – Mutual Recognition – Measuring Performance of the Process

Thank you for listening!