European eCTD Module 1 Version 3.0 Finalized

By 2. November 2015Blog

EMA eCTD specifications – General Update

In October, EMA has officially released the version 3.0 of the European Module 1 eCTD specifications. It is valid for all European countries as well as all European submission types.

The official homepage for electronic submissions (http://esubmission.ema.europa.eu/eumodule1/) has been updated accordingly and no longer lists the version 3.0 specifications as version as public consultation but outlines them as “Entering into force 1st July 2016”.

The timelines for the implementation of the updated specifications have been fixed also:

  • Starting from July 1st 2016, the new eCTD M1 specification can officially be submitted, while the previous version 2.0 will still be accepted.
  • Starting from October 1st 2016 the updated version of the specification will become mandatory.

Changes to be considered for regulatory operations

The following changes requested since the current version 2.0 has gone into effect September 2013 will be implemented with this version:

  • Additional submission types to allow specific regulatory activities. (for example submission of clinical study reports redacted for publication to the EMA, to submit documentation as requested for different post authorisation measures, several paediatric submissions and in case of referrals as well as applications for Certificates of Suitability directed to the EDQM)
  • Submission Unit: The existing attribute “submission type” will be used to describe the regulatory activity from version 3.0 onwards. The new field unit will then describe actions in that regulatory activity further, such as responses to questions from agencies or update due to validation issues.
  • A submission UUID, which is described in more detail below in this article.
  • Various changes for standard terminologies and standard values including agency names have been incorporated in this change too, such as the Austrian agency name and abbreviation.

Submission UUID introduction (Universally Unique Identifier)

Important to consider is the addition of the submission UUID field, as it will allow for unique application identification without combining ambiguous data such as the trade name, application number and other meta data that will not identify an application stream on its own. eCTD tool vendors will need to provide an update to support this technical requirement.

The following quote of the official EU M1 v3.0 specification defines the UUID:

“For this reason, all eCTD sequences built in accordance with this revised specification must contain a universal unique identifier, linking the sequence to the eCTD application to which it belongs. The applicant should generate a UUID based on ISO/IEC 11578:1996 and ITU-T Rec X.667 | ISO/IEC 9834-8:2005. It is a hexadecimal number in the form of xxxxxxxx-xxxx-xxxx-xxxx-xxxxxxxxxxxx, Showing 32 digits and 4 hyphens.”

A sample of such a generated UUID is: 31E96E01-D593-4943-8956-C5BD1334A842.

I believe that that eCTD tool vendors will add an automatically generated meta data field for UUID within their eCTD software, resolving the complexity for regulatory operations user. Since the combination of ISO/IEC 11578:1996 in combination with ITU-T Rec X.667 can potentially be a technical challenge, it is recommended to investigate with each vendor on how the UIDD requirement will be supported.

Once implemented, the UUID will help agencies to reduce the error rate when reviewing applications and will most likely lead to more reliable and faster application processing.

Should you wish to discuss these version 3.0 requirements in more detail, I am happy to help.

Daniel Koppers

Author Daniel Koppers

Cunesoft CTO, He has more than 7 years experience with software development and project management. Moreover, he has a deep knowledge of life sciences and regulated industries. His previous employers include Nextdocs and Adlib Software. He has a degree in business informatics.

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