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eAF

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eCTD

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eCTD v4.0

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HMA eSubmission Roadmap

  • Final HMA eSubmission Roadmap - Updated. 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.(Adopted by the eSubmission CMB on 15.06.2018.)
  • Annex 2 to the HMA eSubmission Roadmap on the implementation of mandatory use of eCTD format for Human regulatory submissions. (Adopted by the eSubmission expert group on 15.06.2018.)
  • Annex 3 to the HMA eSubmission Roadmap on the implementation of mandatory VNeeS format for Veterinary regulatory submissions. (Adopted by the eSubmission expert group on 15.06.2018.)
  • Annex 4 to the HMA eSubmission Roadmap on the replacement of the current PDF electronic application forms (eAFs) with the CESP Application Dataset Management Module (CESP Dataset Module). (Adopted by the eSubmission expert group on 15.06.2018.)
  • Annex 5 to the HMA eSubmission Roadmap on the mandatory use of the Common Repository for EMA led procedures (Adopted by the eSubmission expert group on 15.06.2018.)

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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