Update of eCTD specification documents


Various eCTD specification documents are being updated.   

Attached you will find an overview of the main changes (not exhaustive, see also the tracked-changes versions of the documents):

  • eCTD M1 Spec
    • Notation Let abis quater harmonised throughout (tables 1 and 4)
    • Operator modified under
    • Notation na-co-marketing corrected
    • List of application types modified in Appendix 2 and 4
    • Fixed component modified under 1.2.2 in table 1
    • Life Cycle Operator modified under and in table 1
    • Notation paragraph13 changed to article 13
    • Section 1.2.2 ann form changed to form-add
    • Section 1.12.2 deleted in table 1
    • Comments in table 4 revised, no technical changes
    • Directory 1.5.1 in table 4 corrected to 151-infoaccordappivguidelinebioequivalence
    • Section 1.5.4 added
    • Example for use of CC in Appendix 1 modified
    • Editorial corrections
  • eCTD Validation Criteria
    • Section corrected to foart13
    • Comment in Section 1.12.2 -> no longer applicable
    • Criterion 16.3 P/F -> module excluded from safety assessment. Used for submission of electronically signed documents.
    • Criterion 16.BP5 -> exceptions defined
    • Criterion 15.BP1 file size increased to 200 MB, aligned with EMA
    • Optional folder in Sections 33-lit, 43-lit-ref and 54-lit-ref, aligned with EMA
    • Validation library corrected regarding warning in 15.BP02
    • Minor content-related adjustments
  • Technical files
    • Adjusted in line with M1 Specification and Validation Criteria
    • New Implementation Guidance established
    • New test data with common structure established
  • eCTD Guidance for Industry
    • Minor corrections to content and alignment with M1 Spec v1.5
    • 200 MB file size
  • eCTD Guidance Article 13
    • Minor corrections to content and alignment with M1 Spec v1.5
    • Updated screenshot in Section 8
  • eCTD Questions & Answers
    • Questions and answers expanded

Transition period
The published documents are valid as of 1 April 2020. A 6-month transition period in which DTD v1.4 and DTD v1.5 can be submitted will apply until 30.09.2020. After 01.10.2020, only eCTD submissions according to DTD v1.5 will be accepted.