The European Medicines Agency (EMA) and national competent authorities (NCAs) have officially chosen a new European Review System for eCTDs (Eurs) to enhance the efficiency of electronic submission reviews. After a comprehensive three-year analysis, evaluation, and selection process, ‘EURS is Yours’ (EiY), developed by Extedo-IABG, has been selected. This system will be instrumental in managing the review and lifecycle of eCTDs and various other electronic submissions within the European regulatory framework.
The selection of ‘eurs’ is Yours (EiY) marks a significant step forward for the EURS initiative. The project team extends their sincere gratitude to the representatives from NCAs, assessors, and technical experts who actively participated in the EURS project. Their invaluable feedback on the available tools and system requirements was crucial in making this important decision.
The implementation phase for the chosen EURS tool, EiY, is scheduled throughout 2007 and 2008. To ensure a smooth transition and ongoing development, the EURS group has been re-established. This group comprises representatives from 17 Member States, EMA staff, and experts from Extedo-IABG, as well as key pharmaceutical industry associations including EFPIA, EGA, and EuropaBio.
The newly formed EURS group is tasked with several key objectives:
- Monitoring and Management of Tool Installation: Overseeing the deployment of EiY in accordance with contractual agreements and monitoring the adoption of EiY or alternative review tools by NCAs.
- Specific Discussion of EiY Usage: Developing standardized processes and guidance for the effective utilization of EiY. Establishing a platform for addressing user queries related to all aspects of EiY. Identifying and defining further requirements to optimize EiY functionality.
- Requirements Development for Life Cycle Management (LCM): Developing detailed and clear requirements for managing the lifecycle of electronic submissions. Documenting and publishing these refined requirements for stakeholder access.
- Forum for Issue Resolution: Providing a dedicated forum for discussing and resolving both business and technical challenges associated with the implementation of EiY and other review tools. This includes addressing workflow considerations within the eCTD framework, data migration strategies, archiving solutions, and the management of non-eCTD electronic submissions, alongside broader process-related issues.
- Central Repository Implementation for Centralised Procedure: Defining the strategy and planning for the Central Repository. Identifying and resolving process, technical, and legal/political issues related to its implementation.
Several key deliverables are anticipated to emerge from the EURS group’s work in the coming months. Depending on public interest, many of these will be made available on this website. These deliverables include:
- Status Update – EURS/eCTD review tool implementation progress reports.
- Updated EURS specifications – for public dissemination.
- Specific Standard Operating Procedures (SOPs) for EURS tool utilization.
- Detailed requirements specifically related to the EURS.
- Comprehensive lifecycle management requirements documentation.
- Central repository requirements (covering business and technical aspects, including migration and archiving strategies), encompassing general planning documentation, test plans, and SOPs and process descriptions for the Central Repository for Centralised Procedure.
This initiative underscores the commitment to improving the regulatory review process within Europe through the adoption of advanced electronic systems like EURS and EiY. The continued collaboration of all stakeholders within the EURS group is vital to ensure successful implementation and ongoing enhancement of this critical system.
