European Medicines Agency (EMA) has published eCTD Module 1.4.1 Specification guidance and other supported documents on 9th January 2011. EMA has incorporated some changes in the new specification documents according to the change request (CR). We can find the difference between the EU Module 1 v1.4.1 and the EU Module 1 v1.4 in the EU Module 1 Specification (Version 1.4.1) Release Notes document. However there is no any change in the eu-regional.dtd. However we can expect some major updates soon. There is no any update for implementation time frame.
List of changes in the EU Module 1 Specification (v 1.4.1)
1 Addition of Glossary of Terms:
Glossary of Terms section has been added in the Specification document.
2 Acceptability of “common”:
The “common” and / or country folders are acceptable within the “emea” subdirectories.
3 Clarification re Use of Hyphens:
Hyphens can be used in an eCTD filename.
4 Removal of Reference to DCP:
Reference to the Decentralized Procedure is removed
5 Value for “Applicant” in eCTD Envelope:
6 Continued Use of “EMEA” Acronym:
The acronym, “EMEA” will continue to be used until the next major version of the Specification is released.
7 Agency Name Updated:
The National Competent Authority for Slovenia has been updated in the specification document : Agency for Medicinal Products and Medical Devices of the Republic of Slovenia.
8 Acceptability of File Formats:
The RTF, TGZ and ZIP are not acceptable file formats Only PDF files should be submitted in Module 1 of the EU eCTD.
9 Supportive Documents:
Confirmation is given that such documents should be placed under 1.2 Application Form section with an appropriate filename / leaf title.
10 Release of v.1.4.1 of EU Module 1 Specification:
11 Use of Related Sequence:
Given more clarity about the use of Related Sequence attribute in the specification document.
12 Use of Node Extensions:
Given more clarity about the use of Node Extensions in the specification document.
13 Baseline Submissions:
Given more clarity about the use of Baseline Submissions in the specification document.
The below listed documents has been published in EMA eSubmission website.
It’s really interesting, Thank you very much for posting this information.
ReplyDeleteI really appreciate you for all your efforts.
Thanks for the info - interesting to hear that there is no implementation time frame / deadline from the EMA for this new spec...
ReplyDelete