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15-03-2024
Register for the eCTD v4.0 Vendor Workshop on 27 March 2024
The electronic Common Technical Document (eCTD) is the standard norm for industry submissions for over 20 years and currently implemented by regulators and industry in version 3.2.2. Version 4.0 of eCTD was published in December 2015 with its most recent Implementation Package v1.5 endorsed at the May 2022 ICH meeting.
This workshop, organised and facilitated by the eCTD v4.0 SME Group (EMA, NCAs and Industry), is intended for all eCTD Vendors that are interested in better understanding changes to the EU regional eCTD Specification. The event aims at fostering a discussion around the key sections of the new version of the Implementation Guide, the technical understanding of the implementation of the new standard, including the grouped submissions, document re-use and controlled vocabularies. At the moment, the focus will be on the Centralised Procedures only.
Moreover, during the workshop, the scope and timeline of the pilot, as well as the timeline for the updates of the Implementation Guide, will be discussed.
This session also offers an invaluable opportunity for participants to ask questions and provide feedback on pertinent matters.
Register for this workshop.
After registration you will receive a confirmation e-mail with the link and password to access the workshop. Please make sure to save those to be able to participate to the workshop.
14-03-2024
eCTD v4.0 EU M1 Implementation Guide - draft Version 1.1 now available
A new draft version of the eCTD v4.0 EU M1 Implementation Guide is now available here for consultation. Future versions (together with EU Controlled Vocabularies and other annexes) will be published and announced on the eSubmission website.
21-12-2023
eCTD v4.0 Vendor Workshop Survey
EMA, together with the eCTD v4.0 EU Subject Matter Experts group, is planning a Vendor Workshop in Q1 2024. To assess the availability, interest and further topics for discussion, the Vendors are invited to complete the eCTD v4.0 Vendor Workshop survey by end of day 15 February 2024.
11-07-2023
Updated draft eCTD v4.0 implementation timeline for EU now available
Please see below an updated draft timeline for the implementation of eCTD v4.0 in the EU.
21-04-2022
A draft timeline for the implementation of eCTD v4.0 in the EU was published in the ICH website in January 2022.
22-12-2021
Updated EU Harmonised technical eCTD guidance now available
An updated version of the EU Harmonised technical eCTD guidance and the related release notes are now available here. The updated guidance enters into force 1st February 2022.
16-09-2019
The ICH M8 Vendor Readiness Survey is now closed.
09-08-2019
Vendor Readiness Survey - NEW
The ICH M8 EWG would like to assess the readiness of eCTD v4.0 Vendors and their development and/or readiness to deliver a production ready eCTD v4.0 solution. We request that the eCTD v4.0 Vendor Readiness Survey be completed by September 15, 2019.
eCTD v4.0 Implementation package
After public consultation, discussion with ICH M8 EWG/IWG and final resolution of all comments the final version of the implementation package is now released for implementation purpose.
The package contains the updated eCTD v4.0 EU M1 Implementation Guide and the as well updated controlled vocabulary lists in machine-readable genericode format.
The package can be downloaded from the following link:
The zip folder has the following file and folder:
EU IG v1.0-20180921.pdf |
EU Module 1 eCTD Implementation Guide v1.0 |
EU_eCTDv4_0_Step5_Genericode_20180126 |
Folder of controlled vocabularies as genericode files including style sheet information |
To verify the download, the valid md5 checksum is 03a2f4a13140cb6f50f2fd9b85f0abd1.
Note: Additional samples of submissionunit.xml files will be published at a later point in time.
To support initial understanding, benefits and challenges of eCTD v4.0 implementation in the EU additional information material was developed.
In a short slide deck here the main aspects from the viewpoint of business management are demonstrated.
In a slightly extended version here also technical aspects are considered to provide a more complete overview.
The key documents for the Electronic Common Technical Document (eCTD) v4.0 Modules 2 through 5 was signed off by the ICH Steering Committee in November 2015 for ICH Step 4.
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 most recent version of the package of relevant documents for implementation is accessible on the ESTRI web page.
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.
The package from the 1st and 2nd round of public consultations can be downloaded from here.
This zip folder contains the following files:
EU IG v2.0-20150310_draft_PubCon.pdfs |
EU Module 1 eCTD Draft Implementation Guide v2.0 |
EU_eCTDv4_0_Step2_Comments_ALL.xlsx |
List of comments and their resolution in the 1st d round of public consultation |
EU IG v2.8-20170518_PubCons.pdf |
EU Module 1 eCTD Draft Implementation Guide v2.8 |
EU_eCTDv4_0_Step5_draft_v2_8_Comments IG_CV_XM-statusafter20180912 |
List of comments and their resolution in the 2nd round of public consultation |
For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.
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