Are you currently submitting eCTDs (electronic common technical documents) to European Region (EU)? Or planning for the same in near future? Then we suggest it’s time to pull up your socks as the EU is taking its turn in 2016. As we could decode the details from EU M1 eCTD specification – V 3.0, which was published in the last quarter of 2015, the final version is set to take effect from 1st July 2016 and is set to be mandatory from 1st October 2016.

What companies should realize about the new specification, Module 1 change, is the complexity for it’s:

  • Additional submission types which are going to support specific regulatory activities. The updated specification includes the submission of clinical data reports for redacted publication and supports applications on Certificates of suitability (CEP) which are directed towards EDQM.
  • Granular insights based on the concept of US FDA’s ‘submission unit’. While current submission type exclusively describes about regulatory activities on a broader spectrum, the inclusion of ‘submission unit’ describes the content at a granular level in relation to defined regulatory activity. In simple terms, submission unit gives much more clarity on sequences and their relation in specific. The valid values as defined in the new specification includes, initial, validation-response, response, additional-info, closing, consolidating, corrigendum, and reformat.
  • UUID (Universal Unique Identifier). As it has been said that the new mandate is all about giving importance to the term VALIDATION, the new specification requires UUID, a 32 digit hexadecimal number which links sequences and eCTD applications.  With this, the European regulatory agencies are expected to validate the new sequences based on the uniqueness across applicants and applications. However, older sequences and applications are not expected/required to assign the same UUID.

The deadlines are set. With the major change anticipated, the only solution in front of your organization’s regulatory operations and IT support teams is the software upgradation. The new specification is expected to affect your eCTD publishing, review and validation software. If your software is not upgraded/updated to comply with eCTD Module 1 V3.0, we advise you to consult a global regulatory partner for submission and publishing with an exclusive and updated eCTD submission solution. Plan your eCTD M1 V3.0 transition right away.


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