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eCTD Version 4.0

News

The updated version of the eCTD v4.0 EU M1 Implementation Guide was released for public consultation on 20th May 2017. 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 eCTD4consultation@ema.europa.eu.

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 2017. All vendors are invited, at their own cost to take part. All participants must register in advance, by 22nd September 2017, via email to eCTD4consultation@ema.europa.eu.

Announcement of the start of the eCTD Version 4 Implementation Guide Public Consultation

Following the publication of the ICH Implementation package, the regional Implementation Guide and related documents like the Controlled Vocabularies have been updated.

This public consultation will concern EU Module 1 Implementation Guide including eCTD v4.0 Module 1 requirements of the eCTD XML message, the Regional Administrative and Product Information which are specific for EU purposes and the set of Controlled Vocabularies relevant to EU Module 1 in the format of genericode files.

The package will include also a comments spreadsheet and can be downloaded from the following link:

The zip folder has the following files:

EU IG v2.8-20170522_ PubCons.pdf

EU Module 1 eCTD Implementation Guide  v2.8 (proposed final)

EU M1 eCTDv4.0 CommentTemplate.xlsx

Template to provide comments on the Draft EU M1 eCTD IG v2.7 and Controlled vocabularies

EU_eCTDv4_0_Step5_Genericode_v2_0

Folder of controlled vocabularies as genericode files

 

 


Please note: Any Object Identifier (OIDs) for controlled vocabularies will be provided at a later point in time.

The eSubmission Change Management Board invites all pharmaceutical companies, vendors of eCTD building and reviewing tools and competent authorities to send comments.

Please complete the different tabs on the comments form and provide your comments before 12th of October 2017. The comments forms and/or any questions regarding further development and clarifications of the released draft documents should be sent to eCTD4consultation@ema.europa.eu

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 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 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 round of public consultation can be downloaded from here.

 


 

 


 

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