News

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14-01-2025

Updated version of the "EU eCTD v4.0 Controlled Vocabularies" (.xml format)

An updated version of the EU eCTD v4.0 Controlled Vocabularies is now available here. The updated package contains the missing list (territorial authority) and the unused list was removed (dosage form category).

12-12-2024

EU eCTD v4.0 Controlled Vocabularies in .xml format now available

The package containing genericode (.xml) format for the first version of the EU eCTD v4.0 Controlled Vocabularies is now available here. They are complementing the .xlsx version which was published in October.

03-12-2024

Call for Interest eCTD v4.0 Technical Pilot

The electronic Common Technical Document (eCTD) v4.0 is pleased to announce the launch of the eCTD v4.0 Technical Pilot and invite interested eCTD tool vendors to participate in Step 1. A call for participation in the following steps will be launched at a later stage.

If you have not yet expressed your interest, please send an email to eCTD4consultation@ema.europa.eu by 20 December 2024 to express your intention to participate. If approved, you will receive a confirmation e-mail with further instructions.

Step 1

• Participants: Tool vendors, EMA
• Timeline: Q4 2024 - Q1 2025
• Focus Area: Technical Interoperability

• Participants: Tool vendors (potential collaboration with MAHs), EMA
• Timeline: Q1 2025 (Subject to finalisation of step 1) - TBD
• Focus Areas:
• Simple scenarios (mock submissions, single package/sequence)
• Document lifecycle management (e.g. replacements, updates)
• Handling of multiple file formats, pack sizes, manufacturers
• Review of controlled vocabularies (CV)
• Updating keywords, priority numbers, and document titles
• Document reuse

• Participants: Tool vendors, MAHs, EMA
• Timeline: Subject to finalisation of step 2, TBD
• Focus Areas:
• Expansion of Step 2 scenarios with non-mock data
• Grouped submissions functionality, forward compatibility
• Parallel regulatory activities

PFor a high-level view, please refer to the attached pilot plan.

04-10-2024

EU eCTD v4.0 draft Implementation package now available

An updated draft version of the EU eCTD v4.0 implementation package is now available here.

The package contains the following:

• EU eCTD v4.0 Implementation Guide draft version 1.2 ; this version is focused on CAPs and the main changes since version 1.1 are reflected in the "Document change history" of the file
• EU eCTD v4.0 Controlled Vocabularies, in .xlsx format (version 1); the genericode files (.xml format) will be published in the following weeks
• EU eCTD v4.0 Accepted file formats

13-06-2024

ICH eCTD v4.0 package updated

The ICH eCTD v4.0 package has been updated in response to the change requests and/or discussion within the EWG after its initial release. There has been number of updates to the ICH IG and both the Support Documentation and the Orientation Material presentations have been updated. Additionally, as of May 2024, the Implementation Guide and Controlled Vocabulary documents were split into two different packages to enable Controlled Vocabulary Versioning.

More information can be found on the ICH Official web site: ICH.

AND

ICH Call for Vendor participation now open

A call for vendor participation is now published on the ICH Official website. If you are an eCTD v4.0 Tool Vendor and would like to join the eCTD Tool Vendor Group to discuss eCTD v4.0 implementation, please send the following information listed below to ICHM8Vendors@ich.org:

• First Name;
• Last Name;
• Email;
• Company Name;

Please note that your information will be shared as needed with Representatives of ICH Members and Observers involved with ICH eCTD activities.

The Vendor Group kick-off meeting will be held on 17 July 2024, at 7.00 A.M. ET.

The vendor group is solely intended to facilitate collaborative discussion on the eCTD v4.0 Implementation Specification and timelines.

More information can be found on the ICH Official web site: ICH.

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:

• EU_eCTDv4.0_Step5_ImplementationPackageasof20180921.zip

The zip folder has the following file and folder:

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:

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.