New draft EU Module 1 eCTD specification 1.4.1 available for consultation

A new draft version of the EU regional eCTD Module 1 specification, version 1.4.1 has been published by the European Medicines Agency today. The draft includes some additional change requests and Q&A and is open for consultation for a short period until September 07. Among the more prominent proposed changes are:

EU M1 envelope:

• New submission type attribute value added in the EU M1 envelope: lou = "Letter of Untertaking"
• Clarification for the usage of submission type attribute value "withdrawal" has been added: If application is to be withdrawn during the assessment, the submission type attribute value "supplemental-info" should be used instead.
• High-level submission number element value: In case such a high-level number has not been obtained in advance form the relevant authorities (e.g. in the centralized procedure) the corresponding field should be populated as "xxxx". Note: Only required for worksharings and Type IA groupings of more than one MAA.
• Tracking number: Additional clarification has been added that the tracking numbers must be delivered in response sequences and updates to facilitate the processing
• Additional example values for the "submission-description" element are provided
• Many additional information and instructions have been added on the correct usage of the "related-sequence" element.

File / folder system

• PDF version 1.7 included as acceptable PDF version
• Additional clarification for MS Word files of Product Information is provided: "Track change" versions provided in MS Word format are not required additionally in PDF format.
• PIM (1-3-1-pim) has been removed from the file/folder structure in section 1.3.1 "SPC, Labelling and Package Leaflet"
• Hyphens have been added as allowed elements in the variable parts of the file names of country-specific parts in Module 1
• Supportive documents for M2 - M5 should be placed in the section 1.2 "Application Form". In case or response sequences such supportive documents should be placed within the "Response to Questions" sections.

Others:

• Usage of node extensions should be limited to "critical areas". Note: Unfortunately such areas are not explicitly defined. Node extensions are considered helpful to organize granular reports in Module 5 and to organize response documents in response sequences. However, they are not mandatory to use. The FDA does not accept node extensions in eCTD submissions.

Important note: The EU M1 DTD as provided in Appendix 3 of the M1 specification document is currently not affected by the changes proposed in the draft version 1.4.1. Note: The proposed additional submission type element value "lou" for the Letter of Undertaking has not yet been added to the "eu-envelope.mod" file.

The above-mentioned changes are not exhaustive. For details please be referred to the draft version 1.4.1 of the EU M1 eCTD specification, which is available for download from the EMA / TIGes website (see link at the bottom of this article).

[Source: EMA/TIGes]

Related News:

 EU eCTD Module 1 specification version 1.4.1 released - 09.01.2012 14:43

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