Electronic Common Technical Document (eCTD)

The electronic Common Technical Document (eCTD) format is a standardised interface and international specification for the pharmaceutical industry to transfer regulatory information, developed by the International Conference on Harmonisation (ICH).

The eCTD submission format has been mandatory for new national Marketing Authorisation Applications since 01 July 2018. From 01 January 2019 this format will also become mandatory for all other submission types.

To facilitate Marketing Authorisation (MA) Holders with implementing the change, a series of Q&A documents have been updated and are available on the EMA eSubmission and CMDh websites, key points of which are:

  • Ongoing procedures can remain in NeeS format – this is different to the previous guidance for MRP/DCP
  • Submission of the next regulatory procedure should be completed in eCTD format
    • Exceptions to this are submissions concerning a PSUSA submitted to the PSUR repository

Conversion from NeeS to eCTD format

When converting from NeeS to eCTD format, a baseline submission is recommended but not required. The expectation for this is that the submission comprises of at least a complete Module 3 (Quality) Section of the CTD, however it is up to the applicant to define and justify the documents submitted.

It is possible to submit several baseline sequences during the product lifecycle, for example initially relating to Module 3, then a later sequence relating to Module 4 or 5:

  • The applicant must declare in the cover letter of the submission that ‘the content of the previously submitted dossier has not been changed, only the format’ and the eCTD envelope must be submission type ‘reformat’

In some cases, such as MA transfer, Sunset Clause notifications or Mockup submissions, regulatory activities will still be handled outside of the eCTD sequence. These will be defined by individual National Competent Authorities.

How EUDRAC can help

EUDRAC has many successful years of publishing and submitting documents to National Competent Authorities and the EMA. The publishing team has knowledge of the most up to date submission systems and has developed a rugged publishing process; including technologies to aid the process and consistency-check the submission documents.

For further information please click here to contact us.

Useful References

Q&A document on how to handle ongoing procedures in relation to mandatory eCTD format
http://esubmission.ema.europa.eu/tiges/docs/Q&A on how to handle ongoing procedures in relation to mandatory eCTD format.docx

Q&A document on mandatory eCTD format for National Procedures
http://esubmission.ema.europa.eu/ectd/Q and A on mandatory eCTD in NP_Nov 2018  endorsed by CMDh_for adoption.docx

CMDh Guidance on eSubmission
http://www.hma.eu/277.html

Technical Guidance for EU eCTD Submissions, Version 4.0
http://esubmission.ema.europa.eu/tiges/docs/eCTD Guidance v4 0-20160422-final.pdf