Introduction and Best Practices about Electronic Submissions in eCTD Format

Presented by Dr. Silke Nolkemper, Regulatory Affairs Specialist, EXTEDO GmbH

Introduction of eCTD

  • CTD vs. eCTD: differences between paper dossiers and electronic dossiers
  • General structure of an eCTD
  • Recommendation for industries/ applicants
    • Hardware / software specification
    • IT knowledge, applicant competency etc.

Details of the eCTD-structure

  • Files and folders
  • Meta data
  • Bookmarks and Hyperlinks
  • XML-backbone, Envelope
  • Lifecycle Attributes Experience in EU in e-CTD: how can several strengths and dosage forms be handled in one eCTD dossier (handling of specific sections)

eCTD Life Cycle Management

  • Submission Lifecycle, e.g. Variations, line Extensions
  • Document Lifecycle (add/replace/delete/append documents)
  • Specifications: EU, TH, other regions
  • Time of e-CTD preparation and format to be used

eCTD Best Practices

  • Do & Don't
  • The most common validation issues and how to solve them