What is eCTD?
eCTD is the electronic transfer of information to regulatory agencies based on the Common Technical Document (CTD) format. eCTD utilizes PDF documents linked via XML backbone.
The guidance on CTD was finalized by the International Conference on Harmonization (ICH) in 2003. Today the CTD format is mandatory for paper-based marketing applications in Europe, Japan, Canada, and other regions, and is highly recommended by FDA. The eCTD format has become mandatory in key regions for electronic submissions. Since January 2010, the European Medicines Agency has required all applications in the centralized procedure use this format. FDA released the final binding regulatory guidance regarding this new format on May 5, 2015, which set in motion a 36-month timeline. The following submission types must be submitted in eCTD format beginning May 5, 2017: New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA), Biologics License Applications (BLA), and Drug Master Files (DMF). IND submissions will be required to be submitted in eCTD format on May 5, 2018. FDA has exempted all non-commercial INDs from mandatory eCTD format. This includes investigator-sponsored INDs and expanded access INDs (eg, emergency use INDs and treatment INDs).
Beginning October 1, 2015, CCS Associates is fully equipped to submit dossiers to regulatory agencies via the Electronic Common Technical Document (eCTD).