This guidance document outlines the creation of a regional backbone file according to the Canadian Module 1 schema. The Canadian Module 1 Schema files are to be used in the preparation and filing of drug regulatory activities in the electronic Common Technical Document (eCTD) format established by the International Conference on Harmonization (ICH).
This draft guidance document is meant be read in conjunction with:
• Draft Canadian Module 1 Schema Version 2.1;
• Draft Guidance for Industry: Preparation of Drug Regulatory Activities in Electronic Common Technical Document (eCTD) Format.
It is expected that this document will be further modified based on comments received during the consultation period. It should be noted that, although Clinical Trial Applications (CTA) and Drug Master Files (DMFs) are included in the schema, they are not yet accepted in the eCTD format. Please consult the Preparation of Drug Regulatory Activities in Electronic Common Technical Document (eCTD) Format to verify the scope of regulatory activities accepted in the eCTD format
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