Health Canada has requested to prepare compulsory requirements for submitting dossiers using the electronic common technical document (eCTD) format before 1st January 2019.
Implementing eCTD format will help to make drug master files (DMFs) submissions to the regulatory authority’s Common Electronic Submissions Gateway (CESG) easier and more consistent.
After the Cooperative Research and Development Agreement (CRADA) between Health Canada and the US Food and Drug Administration (FDA) in 2013, CESG has become an obligatory mechanism for DMF submissions.
In the framework of implementation of the CRADA, Health Canada and the FDA has changed existing gateways for electronic submissions approximately 4 years ago in such a way that drugs and biological products applications could be submitted via the same technology. The purpose of these alterations is to decrease expenses associated with the necessity to meet different technical requirements set by Canada and the US.
The regulator has stated at the beginning of the consultation on the special eCTD requirements: “As Health Canada continues to move towards a common submission intake process and stay aligned with other leading regulatory authorities, eCTD format will progressively become the mandatory format for the majority of dossiers and regulatory activities filed to Health Canada.”
Therefore, implementing a standardized eCTD format will provide a greater degree of formalization and unification of dossiers. Leading world regulators (European Medicines Agency [EMA] and FDA) have already conducted a smooth transition to eCTD. Currently, eCTD has started to be implemented in member countries of the Eurasian Economic Union as a part of the common market of medicines within the Union.