Draft guidance document profile: Canadian Module 1 Technical Implementation Guide for the Electronic Common Technical Document (eCTD) v4.0 Format

Draft guidance document profile: Canadian Module 1 Technical Implementation Guide for the Electronic Common Technical Document (eCTD) v4.0 Format This is a technical document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. 2023-11-01 Health Canada open-ouvert@tbs-sct.gc.ca Health and Safetya technical documentdraft guidance documentmodule-1 technical-implementation guideelectronic common-technical documenteCTDICH eCTDv4.0 Formatv4.0 implementation guideInternational Council-for-HarmonisationICH Draft guidance document profile: Canadian Module 1 Technical Implementation Guide for the Electronic Common Technical Document (eCTD) v4.0 FormatHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/public-involvement-consultations/drug-products/draft-guidance-canadian-module-1-technical-implementation-guide-ectd-v4-format/document.html Draft guidance document profile: Canadian Module 1 Technical Implementation Guide for the Electronic Common Technical Document (eCTD) v4.0 FormatHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/public-involvement-consultations/drug-products/draft-guidance-canadian-module-1-technical-implementation-guide-ectd-v4-format/document.html Draft guidance document profile: Canadian Module 1 Technical Implementation Guide for the Electronic Common Technical Document (eCTD) v4.0 FormatHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/participation-public-consultations/medicaments/ebauche-ligne-directrice-guide-de-mise-en-ceuvre-technique-module-1-canadien-format-ectd-v4/document.html

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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