22.07.2015

New draft version of EU eCTD Module 1 v3.0 released for public consultation

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A new draft revision of the future version 3.0 for the EU eCTD Module 1 has been released on the CMB eSubmission website. The release consists of the following documents:

The update includes

  • Implementation of several change request since release of the current version 2.0 of the EU Module 1 eCTD specification
  • Additional submission types to allow specific regulatory activities to be indicated in the EU Module 1 "Envelope"
  • Two additional attributes will be introduced to support automation of processes at the receiving agencies (quotation):
    1. The applicant should generate a UUID based on ISO/IEC 11578:1996 and ITU-T Rec X.667 | ISO/IEC 9834-8:2005 and providing a randomly generated hexadecimal number in the form of 8-4-4-4-12, including 32 digits and 4 hyphens. For the first sequence being submitted following this version of the specification of an application in eCTD format must be provided regardless whether this is an initial submission or simply the first sequence  following this version of the specification. The UUID should be referenced in every subsequent sequence to allow securely assignment of the sequence to the correct application regardless of any other (presumably inconsistent item like procedure number) metadata in the eCTD envelope.
    2. The concept of “submission unit” will be introduced. The existing attribute of the “submission type” will then solely describe a regulatory activity. The “submission unit” will describe actions within that regulatory activity like an initial submission of an application, an update due to validation issues, responses to questions from agencies, etc.The extension to two levels will exactly mirror the purpose of sequences and allow more clarity to understand the sequence order.

Further changes include updates of various agency names and abbreviations in the DTD. For details please be referred to the highlighted version of the specification. The timelines are as follows:

  • Deadline for comments: September 14, 2015
  • Final version of the specification: End of September 2015
  • Entry into force: July 1, 2016 (optional use)
  • Mandatory usage: October 1, 2016.

Comments can be made using the provided template and should be sent to the attention of EUM1Spec@ema.europa.eu.

[Source: EMA / CMB website]

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