Description

This document is intended to provide Industry with guidance for the preparation of drug submissions for Biotechnological/ Biological Products. It is structured using the International Council for Harmonisation (ICH) Common Technical Document (CTD) format.

Resources

Name	Format	Description	Link
Preparation of the Quality Information for Drug Submissions in the CTD Format: Biotechnological/ Biological (Biotech) Products: Guidance for Industry	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/guidance-industry-biotechnological-biological-biotech-products.html
Preparation of the Quality Information for Drug Submissions in the CTD Format: Biotechnological/ Biological (Biotech) Products: Guidance for Industry	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/produits-biologiques-radiopharmaceutiques-therapies-genetiques/information-demandes-presentations/lignes-directrices/ligne-directrice-produits-biologiques-issus-biotechnologie.html

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