##  [Health Canada eCTD Deadline and Things to Note for Successful Submissions](/blog/health-canada-ectd-deadline-and-things-to-note-for-successful-submissions) 

    December 7, 2017 

  ![Health Canada eCTD Deadline and Things to Note for Successful Submissions]()

2 min read 

- [Medicinal Products](/blog-main-categories/medicinal-products)
- [Publishing and Submission](/blog-main-categories/publishing-and-submission)





 

The health authority of Canadian landscape, Health Canada (HC) has revised the submission requirements and mandated submissions to be in electronic format for [certain filings post January 1st, 2018](/blog/ectd-in-limelight-should-hc-electronic-submissions-be-your-next-focus). That means, beginning the first day of 2018, Health Canada will accept submissions in electronic common technical document (eCTD) format only for certain regulatory filings, which include:

- New Drug Submissions (NDSs)
- Supplemental NDSs (SNDs)
- Abbreviated NDSs (ANDSs)
- Supplements to ANDSs (SANDSs)
- All lifecycle submissions pertaining to the above

In wake of the deadline, it is crucial to know the structure and content Regulations established by the Canadian Health Agency. Referring to [the Agency’s guidance](https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements.html), below are a few common details we have decoded for you to compile [eCTD submissions](https://www.freyrsolutions.com/global-ectd-publishing-and-submission-services) in a compliant way. What should be included?

**Cover Letter:** The Health Canada and ICH, both recommend that the cover letter adjoining the submission of any type, must detail the following content in it.

- Clearly state what is being provided and the reason for filing
- Include a reference to correspondence with Health Canada, prior to filing
- Include reference to a request letter (including an Advisement Letter), if applicable
- Manufacturer/Applicant’s name
- Brand name
- Control number
- Dossier Identifier
- Regulatory activity type
- Sequence number
- Any cross-referenced regulatory activity should be clearly stated (date the Regulatory activity was approved)
- Contact name and email address for the eCTD publisher where the Validation Report (if required) should be sent
- PSUR / PBRER to indicate the reason for filing
- RMP (when provided to MHPD) should indicate reason for filing
- If there is a labeling reference product, DINAs should indicate
- Response to a request for clarification

**Life Cycle Management (LCM) Table:** The HC mandates that submissions must include an LCM Table which indicates all Regulatory transactions and how they are inter-related. They must include; Sponsor name, Brand name, Dossier identifier, Sequence number, Date Filed, Control number, Related sequence, Regulatory activity type, and Sequence description.

**Folder Structure and File Naming Convention:** The folder structure and file naming convention is broad and needs a [Regulatory expert](https://www.freyrsolutions.com/) to detail minutely. But it can be briefly consolidated as follows:

- Top Level Folder and Dossier Identifier
- Sequence Number Folder
- Module 1 Folder
- Module 2 to 5 Folders
- Util and dtd folders
- Content File Naming Convention

**eCTD Structure and Leaf Title:** This section too has comprehensive details and will need a deep dive for thorough inspection before using it to prepare document. But, in short, the divisions include:

- Module 1: Administrative and Product Information
- Module 2 to 5
- Leaf Titles

The structure provided above is concise and in tight timelines may seem complex to follow through. The need of the hour is for a comprehensive [Regulatory consultation](https://www.freyrsolutions.com/medical-devices/medical-device-regulatory-consulting-services) for thorough understanding of the submission formats and towards an audit-ready submission. With a comprehensive knowledge of global [Regulatory publishing](/regulatory-publishing-and-submissions) trends and submission formats, Freyr has proven expertise for dossier submissions towards the Canadian market. Consult to be Compliant.