What’s Included in the New EU Module 1 Specification v1.4?

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As promised, the EMEA released Version 1.4 of the EU Module 1 Specification on schedule in August. The new spec has some changes that will impact eCTD assembly, publishing, verification and viewing software tools.

The EMEA has reached out to the vendor community to ensure that they are aware of the changes to ensure that they can modify their products in advance of the required implementation timeline.

It’s worth reproducing that timeline here – quoting from EU Module 1 Implementation Guidance:

  1. Applicants are advised that, from 1st January 2010, when the new variation regulation comes into force, the EU M1 v1.4 must be used for any eCTD submission for any European procedure that contains grouped variations or is subject to a worksharing agreement. Grouped variation or worksharing eCTD submissions provided from this date using any previous version of the EU M1 specification (v1.0. v1.1, v1.2.1 or v1.3) will not be accepted. All European Regulatory Authorities must therefore be able to accept eCTD submissions built using EU M1 v1.4 from 1st January 2010.
  2. Applicants are further advised that, from 1st July 2010, the EU M1 v1.4 must be used for all eCTD submissions for all European procedures, and any eCTD submissions provided from this date using any previous version of the EU M1 specification (v1.0. v1.1, v1.2.1 or v1.3) will not be accepted

The nature of this timeline is related to the most significant change in V1.4: the Specification and DTD have been amended so as to support the New Variations Regulation. The envelope has been reviewed so as to support the different modes of submission for variations: single, grouping and worksharing.

A new envelope element, submission ‘mode’ is now provided for use with variations and line extensions. A related change involves the use of a “high-level” submission number for worksharing submissions and certain grouped submissions. Submission publishing tools will require user interface changes to accommodate these requirements, and publishers will need to be aware of their correct usage. EMEA has also provided a number of sample submissions to illustrate the correct use of these elements.

Another significant change is a new limit on folder path length. The Specification has been amended to update the maximum length for file path. The new maximum length has been set to 180 characters. That is, the overall folder and file name path length starting from the sequence number should not exceed 180 characters, for any file in any module.

This is an EU regional requirement, and it is acknowledged that this is less than the ICH agreed overall path length. This may cause issues for anyone using attribute-related folder paths (such as drug substance, indication, etc.) of more than a dozen characters or so. Although this won’t affect sequences already submitted, it will mean that some sponsors may have to modify their conventions in this area (keep in mind that the HAs have said that folder names do not have to actually match metadata in the eCTD backbone).

A few more minor changes:

  • The ATC number metadata in M1 has been retired
  • A few new values have been added for submission type
  • A new stylesheet has been supplied
  • Naming conventions for the tracking table have been updated

Sponsors need to prepare to accept and validate updated versions of their publishing tools and will need to work with vendors to ensure that updates will be available in advance of the portion of the deadline that applies to them based on their submission plans. They will also need to update some procedures.

It’s worth reviewing the EU Module 1 V1.4 Release Notes to make sure you understand all the changes…

In other EMEA news, a The NeeS validation criteria v1.0 (a set of technical validation criteria to be applied to all non-eCTD electronic submissions has been drafted. Finally, Practical guidelines on the use of the eCTD format for the Plasma Master File (PMF), for the submission of MAAs for plasma derived medicinal products and medical devices that include a PMF certificate, and for 2nd step procedures, has been released by EMEA.

Author: GS

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