Requirements

More and more health agencies require companies to submit their dossiers in eCTD format. In EU, US and Canada this format is now mandatory for some types of dossiers. In Australia, Gulf region, Japan, Thailand, South Africa and Switzerland, it is optional to submit dossiers in eCTD format as well.

EU
The EMA and EU competent authorities published an eSubmissions roadmap. From January 1st, 2019 onwards all dossiers should be submitted in eCTD format for human pharmaceutical products or V-NEES for veterinary pharmaceutical products. CP, MRP and DCP dossiers should be submitted in eCTD format already.

US
The FDA requires companies to submit NDA, ANDA and BLA dossiers in eCTD format. From May 5th, 2018 onwards, eCTD format will be mandatory when submitting IND and master files.

CANADA
Health Canada accepts the following specified regulatory activities in eCTD format only: NDS, SNDS, ANDS, SANDS. They recommend to submit other types of dossiers in eCTD format as well.