The European Medicines Agency (EMA) is advancing regulatory processes with the recent release of eCTD EU Module 1 Specification V3.1, Validation Criteria V7.1, and updates to accepted file formats. This marks another important stride towards harmonization and modernization. The Human Harmonisation Group (HHG), a key body within the EMA, has reviewed the change requests by stakeholders for the eCTD EU Module 1 Specification, resulting in three vital documents now open for public consultation:  

Proposed Changes in eCTD EU Module 1 Specification:  
In general, the HHG aims in its amendments to enhance clarity, security, and efficiency in the submission process. 

1. General Architecture Enhancements:

  • Added reference to an annex on accepted regional file formats. 
  • Editorial changes explaining the use of authentication measures, including electronic signatures. 
  • Clarifications in the general architecture for Module 1. 
Appendix Refinements: 

Appendix 1 has been updated as follows: 

  • A typo in the Identifier (UUID) has been corrected. 
  • Clarifications have been provided for the "consolidating" type in the Submission Unit. 
  • Additional clarification has been incorporated regarding the utilization of Related Sequence and Submission Unit type elements. 

In Appendix 2, specific clarifications have been introduced: 

  • Clarification for tracking table in item 6. 
  • Clarification regarding additional data, specified under item 70, with a note that it is not applicable for CP submissions.
  • Appendix 2.1 introduces the destination code "xi" for UK Northern Ireland while Appendix 2.2 indicates the language code "ga" for Irish. 
  • In Appendix 2.4, proposed English versions of agency names have been included where they were previously missing. 

  2. Changes to Validation Criteria:  

  • 15.1 – changed to Best Practice, renamed to 15.BP1.1, content updated. 
  • 15.2 – changed to Best Practice, renamed to 15.BP2.1, content updated.  
  • Introduction of new criteria, such as 15.BP6, specifying a maximum size for individual video files. 
  • Mandatory tracking table (15.11) for all submission types. 
  • Clarifications on tracking table naming (15.12).

    Picklist Values:
  • Line 37 –updated to “xi” (UK) 
  • Line 49 – added Irish (“ga”) 

3. Changes in EU Accepted File Formats:  

  • PDF/A is highly recommended for file format. 

The effective date for these changes will be announced upon publication, allowing a transition period of nine months for implementation. 

Stakeholders are encouraged to actively participate in the public consultation, with the deadline for submitting questions and responses set for 12 January 2024 via email at EUM1Spec@ema.europa.eu 

 

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