Draft Guidance Document: Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs)

Draft Guidance Document: Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs) This document is intended to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. 2023-09-01 Health Canada open-ouvert@tbs-sct.gc.ca Health and SafetyQuality Guidancechemistry and manufacturingNew Drug SubmissionsNDSsAbbreviated New-Drug SubmissionsANDSssubstances of syntheticsemi-synthetic origindrug productsDivision C.08Food-and-Drug Regulations Draft Guidance Document: Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs)HTML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Draft Guidance Document: Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs)HTML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

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.

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