CRED ERP 25

Folder structure

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Contents

XML backbone

• Amendments/supplements are never incorporated into the original submission but remain entirely separate, with its own XML backbone.

General Points/Recommendations: • Vendors can provide eCTD builder tools and consultancy on eCTD preparation • Document preparation: if documents authored in Word using templates with styles, bookmarks and electronic cross-referencing, then PDF files generated from these can be automatically bookmarked and hyperlinked internally • Recommend securing an electronic document management system • Ensure that electronic source documentation will be available from third parties, e.g., licensing partners and CROs • Study the templates for assessors in order to understand what they are looking for in the responses Further reading: https://www.ema.europa.eu/en/general-regulatory-procedural-guidance https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/marketing-authorisation- guidance-documents https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/assessment-templates guidance#day-80-and-day-120-assessment-report-templates-(containing-guidance)-section https://admin.ich.org/sites/default/files/inline-files/eCTD_Specification_v3_2_2_0.pdf