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eCTD v4.0

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These documents have been created/adopted by the eSubmission CMB or by the TIGes.

HMA eSubmission Roadmap

  • Final HMA eSubmission RoadmapUpdated. The final updated version of the eSubmission Roadmap 2.1 was adopted by the EU TMB  and endorsed by the HMA on the 28th of February 2018. The summary of main changes is available in the Release Notes. The updated Annexes to the Roadmap are being published as they become available to reflect further details on the practical implementation steps.
  • eSubmission Roadmap (visual representation) The final updated version of the eSubmission Roadmap v2.1 visual representation of the timelines.

Annexes to the eSubmission Roadmap

  • Annex 1 to the HMA eSubmission Roadmap on the implementation of eCTD version 4.0.
  • Annex 2 to the HMA eSubmission Roadmap on the implementation of mandatory use of eCTD format for Human regulatory submissions.

These revised versions of the annexes to the roadmap have been adopted by the eSubmission CMB on 04.05.2018.

EU Harmonised eCTD Guidance

EU Harmonised NeeS Guidance

EMA eSubmission Guidance for the Centralised Procedure

  • All EMA guidance documents, both practical and strategic, as well as Statements of Intent relating to eCTD and electronic submissions, can be found on the EMA external website here.

Best Archiving Practice

 

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