Preparation of the Quality Information for Drug Submissions in the CTD Format: Biotechnological/ Biological (Biotech) Products: Guidance for Industry

This document is intended to provide Industry with guidance for the preparation of drug submissions for Biotechnological/ Biological Products. It is structured using the International Council for Harmonisation (ICH) Common Technical Document (CTD) format.

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Title (French) Préparation des données sur la qualité pour les présentations de drogues dans le format CTD: Produits biologiques ou issus de la biotechnologie : Ligne directrice à l'intention de l'industrie
Update Frequency as_needed
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Open Canada Date Published 2018-09-04 00:00:00
Open Canada Date Modified
Open Canada Subject ["health_and_safety"]
Open Canada Keywords {"fr": ["conseils pour l'industrie", "informations sur la qualité", "présentations de drogues", "format CTD", "produits biotechnologiques", "biologiques et biotechnologiques"], "en": ["guidance for industry", "quality information", "drug submissions", "CTD Format", "biotechnological", "biological", "biotech products"]}
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