eCTD Publishing & Submission

Let JensonR+ take care of your eCTD publishing requirements.
eCTD, or electronic Common Technical Document – is the electronic format that a medicine dossier is required to be in for submission to a Competent Authority (CA) when obtaining a Marketing Authorisation (MA).

All subsequent variations to the MA after approval must also be submitted in this format. Breaking this down, the CTD is the traditional 5 module hierarchy whilst the eCTD cross-links these modules on an XML backbone. The eCTD is an international standard followed to ensure the effective organisation of regulatory information, simplifying the submission process for the MA holder, and facilitating navigation by the CA.

It is important to get eCTD publishing right as this is the format in which the CA will receive the MA application. A correctly published sequence can ensure faster market access, through successful validation and reducing the number of RFIs (questions from the CA).

Case Study

Challenge:

A client, with a growing portfolio of MAs (now at 100+), some already in eCTD format and some not, required support in publishing and submitting as they did not have this capability in house. The submissions covered the full scope from initial MA applications to MA maintenance life cycle activities.

Solution:

JensonR+ was able to continue the client’s existing eCTD life cycles and create new life cycles for MA applications, or for existing MAs that had not yet been updated to eCTD. The MAs ranged from those that were purely national, that were part of MR/DC procedures, or those for Centrally Authorised Products.

Benefits:

In addition to the client not requiring their own publishing software with their own publishing experts, they can be assured that our team of publishing experts is available when required and able to liaise with their regional regulatory managers to ensure submission deadlines are met; this allows their regulatory managers to focus on documentation collection and preparation for submissions related to the MAs in their region.

Get in touch with us to find out more