Mandatory use of eCTD in 2019 – Are you ready?

Mandatory use of eCTD for all submission types and procedures by 1 January 2019
From January 2019 all submissions in CP, DCP, MRP and NP, related to authorisation and regulatory maintenance (variations) of human medicinal products, must be submitted in eCTD format.

Baseline dossier
Submission of a baseline CTD Module 3 serving as a start of an eCTD is highly recommended by the agencies, as the baseline dossier facilitates the review and assessment of future applications. A baseline submission is a compiled submission of the current status of the dossier, i.e. resubmission of currently valid documents that have already been provided to an agency but in another format. The sections provided to make up a baseline can be defined by the applicant, but any omissions should not render the submitted content to be misleading. A baseline would typically consist of the Module 3 documents that tend to change over time during the lifecycle of the product.

NDA Service
NDA´s well experienced team may assist you with publishing of variations in eCTD format as well as with conversion of your current documentation to eCTD format.
For more information about eCTD publishing and NDA´s other services, please contact office@ndareg.com.