Background information eCTD format is the principal electronic submission format required by the European Medicines Agency (“EMA”) in the centralised market authorisation procedure since 2010.

The EMA has now reinforced its commitment to electronic submissions by mandating the use of the eCTD format for the centralized procedure of all electroniconly submissions. "From here on in, noneCTD ...

The eCTD 4.0 format introduces enhanced capabilities for managing complex data structures and offers greater flexibility in the regulatory submission process. With eCTD 4.0, sponsors benefit from ...

Regulators at Health Canada have announced the finalization of guidance intended to assist sponsors in preparing electronic common technical documents (eCTDs) to submit their pharmaceutical dossiers ...

After years of transitioning in the requirement for drug and biologics sponsors to submit applications to the U.S. FDA in the electrical common technical document format (eCTD), the agency is getting ...

This two day workshop will provide you with an in-depth review of the content and format requirements of the CTD/eCTD.