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Update of eCTD Module 1 Specification to version 3.0.4

Update of eCTD Module 1 Specification to version 3.0.4

Update of eCTD Module 1 Specification to version 3.0.4
April 28, 2021

The EU eCTD Module 1 Specification has been updated to version 3.0.4 in April 2021 to reflect clarifications.

In the updated version, which is available for immediate use, there are no changes to the DTD (version 3.0.1 is still valid) or to the validation criteria. It contains editorial changes due to Brexit, and it includes information about the use of UUID (which should be unique for each eCTD lifecycle), format related guidance (e.g., documents that include digital signatures should be accepted) and some other clarifications.

The most remarkable updates are listed in the following table:

UKThis country code should be used for UK Northern Ireland UK(NI) until a new major version of the EU eCTD M1 specification is released that will include the correct term.
UK-MHRAThe agency code UK-MHRA refers to the United Kingdom of Northern Ireland when included in an EU eCTD submission.
STTThe (sequence) tracking table should be included in all eCTD submissions, including national and centralized procedures (NP and CP)

The validation criteria have not been updated to include the requirement for a tracking table within NP and CP (so it will not be a cause for rejection), but the requirement will be included in a future version.



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