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eCTD

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eCTD v4.0

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Paediatric submissions

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

HMA eSubmission Roadmap

  • Final HMA eSubmission Roadmap (adopted) The final updated version of the eSubmission Roadmap 2.0 was adopted by the EU TMB on and endorsed by the HMA on the 24th of February 2017. The summary of main changes is available in the Release Notes. Updated Annexes to the Roadmap will be published to reflect further details on the practical implementation steps.
  • eSubmission Roadmap (visual representation) The final updated version of the eSubmission Roadmap v2.0 visual representation of the timelines.

Annexes to the eSubmission Roadmap

  • Annex 2 to the HMA eSubmission Roadmap on the implementation of mandatory use of eCTD format for regulatory submissions. This revised version of the annex 2 to the roadmap has been adopted by the eSubmission CMB on 10th March 2017.
  • Annex VI to the HMA eSubmission Roadmap on the implementation of mandatory use of VNeeS format for Veterinary regulatory submissions. This revised version of the annex VI to the roadmap has been adopted by the eSubmission CMB on 5th May 2017.

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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