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eCTD v4.0


EU Module 1







After a period of analysis, evaluation and selection spanning 3 years, the European Review System for eCTDs (EURS) to be used by EMA and generally offered to national competent authorities for the review and life cycle management of eCTDs and other electronic submissions has been chosen. The selected tool is 'EURS is Yours' (EiY) from Extedo-IABG. Sincere thanks are extended to all those representatives of NCAs, assessors and technical experts alike, who have participated in the EURS project, and who have contributed so much in terms of feedback on the available tools and requirements. 2007 and 2008 will see a period of implementation of the chosen tool, and a new phase of work for the EURS group to continue to develop requirements, resolve implementation issues, and monitor the implementation. It is hoped that those who have contributed so far to the project will continue their valuable work.

For the above mentioned purpose the EURS group has been re-constituted with representatives from 17 Member States, EMA staff and representatives of the EMA contractor Extedo-IABG as well as representative from pharmaceutical associations, namely EFPIA, EGA and EuropaBio.

The objectives of the group are:

  • Monitoring and Management of Tool installation:
    • Monitoring of the installations of EiY under the conditions of the contract.
    • Monitoring of the development of EiY or installation of other review tools by NCAs.
  • Specific discussion of use of EiY:
    • Development of processes and guidance regarding the use of EiY.
    • Provision of a forum for questions regarding any aspect of use of EiY.
    • Development of further requirements for EiY.
  • Requirements development of Life Cycle Management (LCM):
    • Development and clarification of complex requirements.
    • Documentation and publication of requirements.
  • Provide a forum for discussion and resolution of business and technical issues associated with the implementation of EiY and other review tools, for use in all procedures, including:
    • Consideration of workflow and the place of eCTD.
    • Migration issues.
    • Archiving issues.
    • Management of non-eCTD electronic submissions.
    • Process issues.
  • Implementation of the Central Repository for the Centralised Procedure:
    • Strategy
    • Planning
    • Identification and resolution of issues:
      • Process
      • Technical
      • Legal/political

The following deliverables are expected to be prepared within the coming months. A number of them will be published on this website, depending on public interest:

  • Status Update – EURS/eCTD review tool implementation.
  • Updated EURS specifications – for publication.
  • Specific SOPs related to the use of the EURS.
  • Specific requirements related to the EURS.
  • Lifecycle management requirements.
  • Central repository requirements (business and technical, including migration and archiving):
    • General planning.
    • Test plan.
    • SOPs and process descriptions for use of the Central Repository for Centralised Procedure.

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