eCTD New EU Module 1 Specification

eCTD New EU Module 1 Specification

A revision of EU eCTD
Module 1 Specification has taken place to satisfy several change requests
submitted since version 2.0 of the Module 1 entered in to force, in September
2013. The published version 3.0 has been subsequently updated when errors were
detected in the checksums and an updated version 3.0.1 is now available. Both
versions v3.0 and v3.0.1 will enter into force on 1st July 2016. The versions 3.0 and
v3.0.1 will replace v2.0 on 1 October
after which eCTD sequences built based on EU M1 specification 2.0
version will no longer be accepted. For a parallel period of 6 months, from
October 2016 until 1st April 2017 both versions will be accepted.

The use of version 3.0.1 will be mandatory from April 2017.

See below diagram for the
implementation dates and validity period for the different versions of the

Among the reasons behind
the granting of a New Module 1 specification, there are:

  • The Policy 0070 of Transparency required a new submission type.
  • The use of CESP and EU Gateway with metadata and drive towards
    automation of receipt with UUID (Universal Unique Identifier).
  • A new submission type was needed to support application on Certificates
    of Suitability being submitted to the EDQM.
  • Name changes of Irish and Danish Agencies.
  • The main features added as
    new, or already existing modified, are the following:
  • Introduction of the Universal
    Unique Identifier
    (UUID), a hexadecimal number of 32 digits which guarantees
    that sequences are in the correct life cycle. This unique number will be
    created automatically from by the Software, and should be generated when the
    first sequence in eCTD format is created. The UUID will be kept as reference
    for subsequence submissions.
  • Additional values for submission
    , among the possible choices already existing, in the envelope
    information. These new fields will allow to have a better way to manage
    regulatory activities.
  • For the Transparency Policy 0070 two new submissions type are
    introduced: “redaction proposal version? and “final redacted document?
  • Introduction of the field “submission
    which will describe actions within a specific regulatory activity.
  • The field of related sequencewill be always mandatory required.
  • Addition of new submission typeto support application on CEP
  • Introduction of EDQM as an additional
    to support the process of the CEP application

More details can be found
in the eSubmission EMA web page:

As a consequence, the validation criteria which relates
mainly to the updated EU Module 1 has been updated, which only will affect tab sheet
“eCTD Validation Criteria?. Among the main changes can be listed the following:

  • Checking the field filled of related sequence which is always mandatory
  • 9.7 EU regional XML, which checks the format of UUID if it is well
    formed, according to ISO 11578:1996
  • 9.8 EU regional XML, which checks the UUID is correct and the sequence
    is being loaded into the correct eCTD Application
  • Updates to MD5s in comments etc.

Many other specific codes pertaining
to the validation criteria have been updated. A comparison of the new major version 6.0 of validation
and the current version 5.0 can be download by following this link:

Do you want to know more about ISO IDMP implementation?
eCTD will become mandatory for ASMF/DMF

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