Health Canada recently (09 June, 2023) published an updated guidance on "Preparation of Regulatory Activities in Non-eCTD Format" that describes the filing requirements for regulatory transactions submitted in non-eCTD formats, and provides guidance on their structure, content, and transmission.
The purpose of this guidance is to provide operational guidance and direction to sponsors and Health Canada staff on the preparation of:
Regulatory activities for Human drugs and disinfectants
Regulatory activities for Veterinary drugs
Human and Veterinary Master Files (MFs)
The regulatory transaction must be organized in folders and multiple documents should not be bundled into one file, but rather provided separately. The technical validation is conducted by validation software using the latest published validation rules for the non-eCTD format.
In order to file transactions involving human drugs and disinfectants, the transactions must be sent through the CESG along with the REP. If the dossier ID is unknown, the request must be made through the appropriate dossier ID request form.
To obtain a complete list of acceptable file formats, size of files, etc. refer to the non-eCTD validation rules available on the Filing Submissions Electronically information page.
Click the LINK to know more about the regulatory activities and related regulatory transactions that are eligible for filing in non-eCTD format.
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