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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. 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, below are a few common details we have decoded for you to compile eCTD submissions 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 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 for thorough understanding of the submission formats and towards an audit-ready submission. With a comprehensive knowledge of global Regulatory publishing trends and submission formats, Freyr has proven expertise for dossier submissions towards the Canadian market. Consult to be Compliant.
