eCTD Version 4.0
Implementation in the EU
Following the publication of the ICH Implementation package, the regional Implementation Guide and related documents like the Controlled Vocabularies are being updated. A second round of public consultation is planned to take place in 2017 and will concern the EU Module 1 Implementation Guide including eCTD v4.0 Module 1 requirements of the eCTD XML message, the Regional Administrative and Product Information specific for EU purposes and the set of Controlled Vocabularies relevant to EU Module 1 in the format of genericode files.
The eSubmission Change Management Board invites all pharmaceutical companies, vendors of eCTD building and reviewing tools and competent authorities to follow up this page for news and announcements on the public consultation.
The key documents for the Electronic Common Technical Document (eCTD) v4.0 Modules 2 through 5 have been signed off by the ICH Steering Committee in December 2015 for ICH Step 4. Please also see the ESTRI web page. The ICH M8 Working Group on electronic submission has drafted these documents based on the Regulated Product Submission (RPS) standard established by HL7 in September 2014.
This standard defines the message for exchanging regulatory submission information electronically between applicants and Regulatory Authorities. The XML message provides the ability to describe the contents of the regulatory exchange and all information needed to process the exchange between these two parties.
The ICH Implementation Guide and the respective set of controlled vocabularies will need to be used in conjunction with the EU Module 1 Implementation Guide and an additional set of EU relevant controlled vocabularies, as the eCTD v4.0 message will be incomplete without all of the contents.
If you have any questions regarding the development of eCTD v4.0 standard, please contact: eCTD4consultation@ema.europa.eu.
The package from the 1st round of public consultation can be downloaded from here.