eCTD Module 1

eCTD Module 1

Module 1
Administrative Information and Prescribing Information

The name of the folder for module 1 should be m1.

This module contains administrative information that is unique for each region. Regional guidance will provide the specific instructions on how to provide the administrative forms and detailed prescribing information.

Country (national or EU / USA / Japan)
  • Application number centralised application Number or MRP procedure number
  • Calibri;”>Agency-name picklist value in the most recent EU m1 eCTD specification
  • Submission type picklist value in the most recent EU m1 eCTD specification
  • Procedure type picklist value in the most recent EU m1 eCTD specification
  • Invented-name trade name
  • INN The International non-Proprietary name for the drug substance
  • Sequence The sequence number here must match the sequence number in the folder structure
  • Related-sequence
  • Submission-description This element is used to describe this particular eCTD sequence

Country In the centralised procedure, there should only be one envelope with the entry ‘emea’. For MRP/DCP, each country in the procedure needs to have a separate envelope entry. Common must not be used as a country identifier in the envelope.
Application number The application number should be the centralised procedure/application number (EMEA/H/C/…), MRP/DCP procedure number (e.g. SE/H/1234…) or other national application or licence number as required by NCAs. Multiple entries are possible. The full application number including the regulatory activity identifier should be used if known.

Applicant Entries for ‘applicant’ should be consistent for all eCTDs from any single applicant (legal entity), as they define where eCTDs are stored in internal systems. Consistency of spelling is also relevant over time to allocate the eCTD correctly.
Agency-name Self explanatory, from picklist in the most recent EU m1 eCTD specification. Assure that Country and Agency name will be consistent.
ATC If unknown at the time of submission, the entry can say ‘to be confirmed’.
Submission type From picklist, see m1 specification for further details.
Procedure type From picklist, see m1 specification for further details.
Invented-name The trade name/invented name for the medicinal product covered by the application. If the eCTD covers multiple strengths or dosage forms, this entry does not need to describe the complete name, a simple entry, for example, ‘Wonderdrug’ will suffice.
INN The International non-Proprietary name for the drug substance.
Sequence The sequence number here must match the sequence number in the folder structure.
Related-sequence For a description and example of how to use the ‘related sequence’ entry
12. April 2012Permalink

eCTD file lifecycle

eCTD file lifecycle
lifecycle sequence
document state
Attribute value Meaning Attribute previous file
new The file has no relationship with files submitted previously.
append There is an existing file in a previous submission to which this new file should be associated current and appended
replace The existing file will be replaced by a new file replaced
delete File in the specific folder is not longer relevant. The file is deleted in the current submission but not in the pervious version No longer relevant to the review
22. März 2012Permalink

eCTD Module 5

eCTD Module 5

Module 5 Clinical Study Reports

The name of the folder for module 5 should be m5.

In cases where the application includes multiple therapeutic indications, the reports should be organized in a separate Section m535 for each indication. In such cases, if a clinical efficacy study is relevant to only one of the indications included in the application, it should be included in the appropriate section in m5 (eg m5\53-clin-stud-rep\535-rep-effic-safety-stud\anxiety\5351-stud-rep-contr). If a clinical efficacy study is relevant to multiple indications, the study report should be included in the most appropriate subsection of m535 and referenced as necessary in the equivalent section under the different indication.

In Module 2, a separate “Summary of Clinical Efficacy” module should be submitted for each indication, although closely related indications can be within a single document.
22. März 2012Permalink