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.

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Champ Valeur
Dernière modification avril 17, 2026, 21:39 (TU)
Créé le avril 17, 2026, 21:39 (TU)
criticality_level []
geographic_scope []
open_canada_collection publication
open_canada_date_published 2021-05-26 00:00:00
open_canada_keywords {"fr": ["document d'orientation", "sommaire", "modifications post-avis de conformité", "innocuité et efficacité", "cadre", "innocuité et efficacité", "sur la qualité", "aux nouveaux", "médicaments"], "en": ["summary guidance document", "post-notice of-compliance-changes", "safety-and-efficacy", "framework", "safety-and-efficacy", "quality guidance documents", "post-approval changes to-new-drugs"]}
open_canada_subject ["health_and_safety"]
sensitivity_level unrestricted
title_fr Sommaire : Ligne directrice - Changements survenus après l'avis de conformité (AC) : Document sur l’innocuité et efficacité
update_frequency as_needed