ICH M8 Electronic common technical document (eCTD) v4.0 draft ICH implementation guide v2.0

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Draft guideline

Reference numberEMA/CHMP/ICH/143002/2015
Effective from 
KeywordsElectronic common technical documentelectronic common technical document (eCTD), eCTD v4.0 specification
DescriptionThis draft document provides instructions on how to implement the eCTD v4.0 specification. It describes the way files should be constructed for inclusion in the eCTD. Read together with questions and answers.

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