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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 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 above mentioned form on the different tabs and provide your comments before September 30th, 2017, or any questions regarding further development and clarifications of the released draft documents 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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