Publication of the Health Canada Guidance Document: Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs) (English, HTML)

View metadata and access the original English HTML file: Publication of the Health Canada Guidance Document: Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs).

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Publisher-reported update

2023-09-03

Significant new requirements are presented in the guidance document (i.e. stability studies on three batches of product for existing drugs, commercial scale batches and pilot batch sizes for certain products).

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