PDF Print E-mail


Acquisition of eCTD format conversion software

January 2016

Recently, Idifarma has acquired the software needed for transforming the registration dossiers into eCTD format.

With this software, we can fulfill the last requirements described in the eSubmission Roadmap (http://esubmission.ema.europa.eu/tiges/cmbdocumentation.html), established between the European Medicines Agency and the Competent Authorities of the EU, where it is indicated that from July 2015 it is mandatory to use the eCTD format for new applications of Commercialization Authorization submitted through the Decentralized Procedure (DCP). It is expected that during first quarter of 2017 this requirement will be extended to new applications through the Mutual Recognition Procedure. Likewise, it is expected that in the first quarter of 2018 the use of eCTD format will be required for all the regulatory activities of European Procedures (DCP/MRP).

This last investment is added to all the activities performed by our regulatory affairs department, and Idifarma can provide a more comprehensive service to their clients.

Last Updated on Thursday, 21 January 2016 08:48