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

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HTML

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Publisher-reported update

2023-09-03

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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