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

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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Title (French) Publication de la ligne directrice de Santé Canada - Qualité (chimie et fabrication) : Présentations de drogue nouvelle (PDN) et présentations abrégées de drogue nouvelle (PADN)
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Open Canada Date Published 2020-10-21 00:00:00
Open Canada Date Modified
Open Canada Subject ["health_and_safety"]
Open Canada Keywords {"fr": ["publication de documents d'orientation", "de conseils sur la qualité", "de chimie et de fabrication", "de présentations de drogue nouvelle", "de PDN", "de présentations abrégées de drogue nouvelle", "de PADN"], "en": ["publication of guidance-document", "quality guidance", "chemistry and manufacturing", "new drug submissions", "NDSs", "abbreviated-new drug submissions", "ANDSs"]}
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