Description

This document is intended to provide guidance with regard to the Quality [that is (i.e.), Chemistry and Manufacturing] portion of NDSs and ANDSs for drug substances of synthetic or semi-synthetic origin and their corresponding drug products that are filed with Health Canada pursuant to Division C.08 of the Food and Drug Regulations.

Resources

Name	Format	Description	Link
Draft Guidance Document: Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs)	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/public-involvement-consultations/drug-products/consultation-draft-guidance-document-quality-chemistry-manufacturing-guidance-new-drug-submissions-ndss-abbreviated-new-drug-submissions.html#g1
Draft Guidance Document: Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs)	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/participation-public-consultations/medicaments/ebauche-ligne-directrice-qualite-chimie-fabrication-presentations-drogue-nouvelle-presentations-abregees-drogue-nouvelle-padn.html#g1

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