Module 12 2019

eSubmission guidance

ICH M2 EWG - Electronic Common Technical Document Specification Version 3.2.2 (Jul 2008).

EU Module 1 Specification v3.0.3 Version 2.0 (Apr 2017) BPG eCTD MRP/DCP Revision 3 (Jul 2018) eCTD and ASMF Version 1.0 (May 2018) Q&A ASMF in eCTD (April 2019) eCTD validation criteria Version 7.1 (Sep 2018)

http://esubmission.ema.europa.eu/

The Organisation for Professionals in Regulatory Affairs