ICH M2 Electronic common technical document (eCTD) - file format criteria - Scientific guideline

HumanScientific guidelines

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This document describes required and desired aspects and functionality to be considered in the evaluation of a file format to be accepted for the exchange of regulatory information. It has been developed by the ICH M2 Expert Working Group.

Keywords: Electronic common technical document ( eCTD), file format criteria

Current effective version

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) M2 on electronic common technical document (eCTD) - file format criteria - Step 5

Reference Number: EMA/CHMP/ICH/730231/2014

English (EN) (69.75 KB - PDF)

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