Summary: Guidance Document - Post-Notice of Compliance (NOC) Changes: Framework Document (Pharmaceutical, biologic and radiopharmaceutical drugs for human use only) (English, HTML)

View metadata and access the original English HTML file: Summary: Guidance Document - Post-Notice of Compliance (NOC) Changes: Framework Document (Pharmaceutical, biologic and radiopharmaceutical drugs for human use only).

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Publisher-reported update

2023-09-30

The Framework, Safety and Efficacy and Quality guidance documents apply to sponsors intending to make post approval changes to new drugs (ie. changes to a drug that have received a NOC pursuant to section C.08.004 of the Food and Drug Regulations). This guidance document provides overarching authorities, a general description of the reporting categories and drug submission filing information.