An updated version of the eCTD v4.0 EU M1 Implementation Guide is available for public consultation. The commenting period has been extended to allow sufficient time for thorough review by pharmaceutical companies, vendors of eCTD building and reviewing tools and competent authorities. The new date to submit your comments is 20th of October 2017. Please provide your comments using the comment template to The eCTD v4.0 working group would like to offer an opportunity for all eCTD tool vendors to discuss open points and ask questions on eCTD v4.0 EU Module 1 Implementation Guide. A face-to-face vendor meeting is planned to take place at BfArM in Bonn, Germany on 6th of October 2018. All vendors are invited, at their own cost to take part. All participants must register in advance, by 22nd September 2017, via email to