eCTD PSUR submissions FAQ
Since June 2016, PSUR must be submitted in E.U. in eCTD or NeeS format. The following FAQ answers all your questions about submitting Periodic Safety Update Reports in eCTD or NeeS format:
1Regulatory activities after PSUR submission
When a PSUR has been submitted in eCTD format, is it compulsory to continue all regulatory activities on the product using the eCTD format ?
Yes, it is compulsory.
2Complexity of eCTD PSUR submission
Is it complex to submit a PSUR in eCTD format when you are not an eCTD expert?
If you are starting from scratch and do not use a dedicated software, it is complex and error prone.
eCTD247 proposes an easy to use interface and video tutorials that will enable you to get up to speed quickly. eCTD247 also performs numerous checks to ensure that your submission is valid.
If you do not have the time to publish the submission by yourself, we propose an all inclusive service to manage the submission for you.
3eCTD or NeeS ?
Is it preferable to submit PSURs in eCTD or NeeS format?
eCTD, of course. It is not more complex to submit a PSUR in eCTD than in NeeS format, and the NeeS format being temporary, it is better to chose the eCTD format.
What is eCTD?
eCTD means electronic CTD.
It is an Electronic submission in which the information submitted in support of the application complies with the eCTD structure and file formats. The eCTD dossier essentially consists of the following elements:
- A tree of folders respecting a standardized nomenclature and containing files mostly in PDF format
- A table of contents called “backbone” containing:
- an XML index for modules 2-5 of the CTD (generic modules)
- A regional XML index of module 1 (Europe, USA and Japan)
- A file to make an automatic verification of the dossier sequence integrity (MD5 hash file)
- A folder named “util” which comprises a DTD file and a style sheet to verify that the XML file is syntactically correct, and to visualize it.
5How to submit
Once my PSUR dossier is create in eCTD format, how do I submit it to the authorities?
You will use the PSUR Repository portal, using the relevant procedure. Be careful: it implies that your XEVMPD data are up to date.
What is XEVMPD?
Extended EudraVigilance medicinal product dictionary. Please refer to the following EMA web page for more information