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 1.2.4.4
- 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 1.2.3.1 and 1.2.4.4 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 1.2.2.20 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 no longer applicable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.