Draft guidance document profile: Canadian Module 1 Technical Implementation Guide for the Electronic Common Technical Document (eCTD) v4.0 Format

This is a technical document that provides instructions on how to implement the ICH Electronic Common Technical Document v4.0 (eCTD v4.0) specification for Health Canada Module 1 submission content. The information in this document is provided in a consistent manner with the ICH eCTD v4.0 Implementation Guide.

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Title (French) Ébauche de la ligne directrice : Guide de mise en œuvre technique du module 1 canadien pour le format Electronic Common Technical Document (eCTD) v4.0
Update Frequency as_needed
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Sensitivity Level unrestricted
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Open Canada Date Published 2020-12-09 00:00:00
Open Canada Date Modified
Open Canada Subject ["health_and_safety"]
Open Canada Keywords {"fr": ["un document technique", "un projet de document d'orientation", "un guide de mise en œuvre technique du module 1", "un document technique commun électronique", "eCTD", "ICH eCTD", "format v4.0", "guide de mise en œuvre v4.0", "Conseil international pour l'harmonisation", "ICH"], "en": ["a technical document", "draft guidance document", "module-1 technical-implementation guide", "electronic common-technical document", "eCTD", "ICH eCTD", "v4.0 Format", "v4.0 implementation guide", "International Council-for-Harmonisation", "ICH"]}
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