Summary: Guidance Document- Post-Notice of Compliance (NOC) Changes: Safety and Efficacy

Summary: Guidance Document- Post-Notice of Compliance (NOC) Changes: Safety and Efficacy The Framework, Safety and Efficacy and Quality guidance documents apply to sponsors intending to make post approval changes to new drugs. 2023-09-30 Health Canada open-ouvert@tbs-sct.gc.ca Health and Safetysummary guidance documentpost-notice of-compliance-changessafety-and-efficacyframeworksafety-and-efficacyquality guidance documentspost-approval changes to-new-drugs Summary: Guidance Document- Post-Notice of Compliance (NOC) Changes: Safety and EfficacyHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/post-notice-compliance-changes/safety-efficacy-2019.html Summary: Guidance Document- Post-Notice of Compliance (NOC) Changes: Safety and EfficacyHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/changements-survenus-apres-avis-conformite/innocuite-efficacite-2019.html

The Framework, Safety and Efficacy and Quality guidance documents apply to sponsors intending to make post approval changes to new drugs.

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