Notice - Consultation for Mandatory Requirements of using Electronic Common Technical Document (eCTD) Format when Submitting Master Files (MFs)

May 7, 2018

Our file number: 18-104330-994

Along with the transition to an electronic only environment, Health Canada began accepting Master Files in eCTD format as of October 2015. Preparing MFs in eCTD format facilitates the use of the Common Electronic Submissions Gateway (CESG) which is the mandatory means for transmission of regulatory transactions since January 2017.

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.

Consequently, this notice is published to provide an advanced notice that Health Canada is considering January 1st, 2019 as the date for mandatory filing of all New Master Files in eCTD format. Health Canada is initiating a 90 days consultation period to solicit feedback regarding this proposal. Questions or comments regarding this Notice must be sent to hc.ereview.sc@canada.ca by August 10th, 2018.

Requirements for Master Files prepared in eCTD format

• Prior to filing a MF in eCTD format a sample according to the eCTD and "non-eCTD electronic-only" guidelines^{Footnote 1} must be provided to Health Canada, regardless of a company's experience with using eCTD format.
• A Pre-technical meeting is recommended for company's using eCTD for the first time and is mandatory for MF s Type II and III.
• After a sample has been approved and a pre-technical meeting has been conducted (for MFs Types II and III) a Dossier Identifier must be requested via email to hc.ereview.sc@canada.ca. The request should include a fully completed MF application form.
• Once a sponsor files a MF in eCTD format, all additional information and subsequent transactions (such as updates, letters of access ( LOA), response to clarification requests, etc.) must also be filed in eCTD format.
• All MF transactions must be sent via the CESG. MF Holders are strongly advised to obtain CESG accounts as soon as possible. Refer to the Frequently Asked Questions - Common Electronic Submission Gateway (CESG FAQ) document for further information.

Master File Holders may also convert their existing MFs from non-eCTD to eCTD format as per the requirements listed above. As a baseline requirement when converting MFs from non-eCTD format to eCTD format, the MF Holder must include the entire MF in their first eCTD transaction. It is not sufficient to convert the MF into eCTD format by simply submitting the next transaction in eCTD via the CESG (i.e., submitting an LOA or an Update in eCTD format as a subsequent transaction for an MF currently in non-eCTD format).