As per Health Canada guidance, companies are required to file submissions electronically to Health Canada in either Electronic Common Technical Document (eCTD) format or non-eCTD format, depending on the regulatory activity type.
If you're planning to submit your organization's first eCTD sequence to Health Canada, you should ideally start the preparations 3-4 months in advance.
Following steps are required before submitting the first eCTD sequence:
1. Obtain regulatory transaction description from Agency
The Excel sheet for different regulatory transaction description which is used to build the sequence is available on request from Health Canada. Submit an email request to no-reply.ereview.non-reponse@hc-sc.gc.ca). Please ensure the text 'Request for Regulatory Transaction Descriptions' is in the subject line of the email.
Agency will share a list of descriptions, by regulatory activity type, that details the reason for filing a transaction. Note: This document is updated frequently.
2. Submit eCTD sample sequence
This process can take upto two months. See following wordings from the guidance:
"Sponsors filing a regulatory transaction (Such as: ANDS, NDS, DINA) using the eCTD format for the first time with Health Canada must file an eCTD sample transaction at least two months in advance of filing their formal regulatory transaction in the eCTD format. This period is not a part of, and will also not delay, the review process. Analysis of the sample, serves to identify and resolve the potential technical issues before the actual transaction is filed. The filing of a sample in eCTD format for subsequent regulatory transactions will depend on various factors, including changes in ICH specifications, changes in the Health Canada Module 1 specifications, and changes in technology (e.g., file formats, new tools used by the sponsor to build the eCTD transaction)."
This process requires around two months of time.
3. Obtain Dossier identifier from Health Canada
After sample sequence is accepted, you should send Dossier identifier request to Health Canada, 4 to 8 weeks before submission of actual sequence. This request can be submitted by filling an online form on agency's website.
Creation of the Canadian Module 1 Backbone
The Canadian Module 1 eCTD backbone file comprises three main components:
- A fixed 'eXtensible Markup Language' (XML) Declaration;
- The eCTD Regulatory Transaction Information (metadata); and
- The eCTD Table of Contents describing the actual files provided.
To create the Canadian Module 1 backbone file for a given regulatory transaction:
1. Create an XML file with the appropriate XML declaration using an authenticated eCTD preparation software (for details visit agency's website).
2. Create an <ectd-regulatory-transaction-information> element containing the appropriate metadata values describing this regulatory transaction (for details visit agency's website).
3. Create an <m1-administrative-and-product-information> element containing additional elements as needed for this regulatory transaction (for details visit agency's website). These elements will be of two broad types:
- Heading elements, organizing the content in the Module 1 to meet Health Canada's review requirements.
- Leaf elements, providing a file system reference to each file being submitted in the regulatory transaction as part of Module 1, along with other information such as eCTD check-sum and life-cycle information.
4. Name the Canadian Module 1 eCTD backbone file "ca-regional.xml" and place it in the "ca" subfolder within the Module 1 ("m1") subfolder of the regulatory transaction.
5. Validate the resulting backbone using a suitable eCTD Validation tool.
