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eCTD baseline sequences

Version 1.0, November 2020
30 November 2020
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Description

This guidance is for sponsors converting their dossier format from paper, Common Technical Document (CTD) or Non eCTD electronic Submission (NeeS) to electronic Common Technical Document (eCTD).

  • About this guidance
  • Using a baseline
  • What to include in a baseline sequence
  • Submitting a baseline
  • Transitioning without a baseline

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