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

This document has been developed by the ICH M2 Expert Working Group and maintained by the eCTD Implementation Working Group in accordance with the ICH Process as pertains to the M2 EWG and eCTD change control as it pertains to the eCTD IWG. Read together with  International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) M8 electronic common technical document - questions and answers: Step 5.

Keywords: Electronic common technical document (eCTD)

Current effective version

ICH: M 2: Electronic common technical document (e-CTD) - Step 5

AdoptedLegal effective date: 01/05/2004Reference Number: CPMP/ICH/1840/01