Draft Guidance Document: Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs) (French, HTML)

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Publisher-reported update

2023-09-01

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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