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eCTD PSUR submissions
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:
Regulatory activities after PSUR submission
Yes, it is compulsory.
Complexity of eCTD PSUR submission
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.
eCTD or NeeS ?
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.
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:
How to submit
You will use the PSUR Repository portal, using the relevant procedure. Be careful: it implies that your XEVMPD data are up to date.
Extended EudraVigilance medicinal product dictionary. Please refer to the following EMA web page for more information