Description

Significant new requirements are presented in the guidance document (i.e. stability studies on three batches of product for existing drugs, commercial scale batches and pilot batch sizes for certain products).

Resources

Name	Format	Description	Link
Publication of the Health Canada 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/drug-products/announcements/notice-quality-chemistry-manufacturing-guidance-new-drug-submissions-ndss-abbreviated-new-drug-submissions.html
Publication of the Health Canada 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/medicaments/annonces/avis-qualite-chimie-fabrication-presentations-drogue-nouvelle-presentations-abregees-drogue-nouvelle-padn.html

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