The European Medicines Agency (EMA) has published version 5.0 of its Harmonized Technical Guidance for Electronic Common Technical Document (eCTD) Submissions in the EU on 17 December 2021.
The changes include the following points:
the validation of eCTD submissions concerning errors found during content validation, electronic signatures,
the re-baselining of a broken eCTD lifecycle,
the structuring of the Module 3 Quality Folder, and the PSURs section.
Additionally, some notes have been updated. These include notes on Portals/Gateways, CD/DVD, and Tracking Tables.
Below you’ll find the major changes made to the guidance. You can find the release notes here to view all the changes that were made.
2.9.11 Technical Validation of eCTD Submissions
Errors found during the content validation e.g. mistakes in an application form to be corrected, should be resolved through the submission of a new eCTD sequence using the next sequence number. These errors, which are content errors, must never be resolved by resubmitting an existing sequence by reusing the same sequence number.
An exception to this would be if the envelope is incorrect and it is requested by an agency to be corrected and resubmitted with the same sequence number. In such scenarios, the updated sequence (same sequence number) should only be submitted to the requesting agency.
- From the Harmonised Technical Guidance for eCTD Submissions in the EU. Prepared by the Human Harmonisation Group (page 16)
Electronic signatures are regulated in EU by Regulation (EU) No 910/2014 of the European Parliament and of the council of 23 July 2014 on electronic identification and trust services for electronic transactions in the internal market and repealing Directive 1999/93/EC. For applications of Marketing Authorizations including post-authorization submissions, most NCAs and EMA do not require wet or digitally signed cover letters or application forms if submitted through a portal (e.g. CESP and EMA Gateway) with logon credentials. However, some NCAs still require additional signatures and might accept wet signatures, scanned signatures and/or electronic signatures as specified in the CMDh document ‘Requirements on submissions for New Applications within MRP, DCP or National procedures’ and ‘Requirements on submissions for Variations and Renewals within MRP and National
For EMA submissions, in general qualified and advanced electronic signatures as per the European Commission eIDAS regulation (Regulation (EU) No 910/2014) are accepted.
- From the Harmonised Technical Guidance for eCTD Submissions in the EU. Prepared by the Human Harmonisation Group (page 17)
220.127.116.11 Tracking Table
A tracking table should always be included as an annex to the cover letter for submissions within all procedures. The file should be named cc-tracking-var.pdf and be placed in /XXXX/m1/eu/10-cover/cc (e.g. ema-tracking-var.pdf for a Centralised procedure, common-tracking-var.pdf in an MRP/DCP, or be-tracking-var.pdf in a National procedure)
- From the Harmonised Technical Guidance for eCTD Submissions in the EU. Prepared by the Human Harmonisation Group (page 25)
3.4. Module 3 Quality Folder
Many eCTD dossiers in Module 32s and 32p are currently not well structured. This section has thus been extensively updated to give better guidance on how to structure documents within Module 3. The updated guidance should help improve and facilitate assessment.
If an existing eCTD is not structured in line with the given guidance, the dossier should be restructured with the next submission of a quality variation that affects the relevant content.
- From the Harmonised Technical Guidance for eCTD Submissions in the EU. Prepared by the Human Harmonisation Group (page 28)
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