Announcement of the start of the eCTD Version 4 EU M1 Implementation Guide Public Consultation
This public consultation 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 package also includes a comments template and can be downloaded here
Included in the zip folder are the following:
- EU Module 1 eCTD Draft Implementation Guide
- EU IG v2.0-20150310_draft_PubCons.pdf
- Template to provide comments on the Draft EU M1 eCTD IG and Controlled vocabularies
- Folder of controlled vocabularies as genericode files
Please note: Any Object Identifier (OIDs) for controlled vocabularies will be provided at a later date.
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 relevant tab(s) on the comments form and provide the comments by 22 May 2015 to eCTD4consultation@ema.europa.eu.
If you have any questions regarding further development or you require clarification on the released draft documents, please contact: 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 2014 for ICH Step 2. 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 is accessible on the ESTRI web page for public consultation from mid of February to 22 May 2015.
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.