Electronic Submissions to Health Canada
According to Health Canada, as of September 1, 2004 sponsors are encouraged to prepare and file submissions in eCTD format in addition to their paper-based submissions in CTD format for the following submission types:
- New Drug Submissions (NDS)
- Abbreviated New Drug Submissions (ANDS)
- Supplemental New Drug Submissions (SNDS) and Supplemental Abbreviated New Drug Submissions (SANDS)
- Notifiable Changes (NC) for previously filed eCTD submissions
The eCTD format is also encouraged for the drug component of drug/device combinations where the primary mechanism of action is drug-related. Where the combination product is classified as a device, the use of the eCTD format for the drug component is optional.
Though the preparation and filing of submissions in eCTD format remains optional, sponsors who like to submit in the eCTD format and who need assistance can leverage the Navitas pharmaREADY eSubmissions team’s expertise and experience in eCTD submissions with Health Canada.
The Navitas pharmaREADY eSubmissions team can walk the customer through the following step-by-step approach towards a successful eCTD submissions acceptance with Health Canada:
- Hold technical Pre-Submission Consultation
- File Sample Submission
- Verify Sample Submission
- Correct Errors and Submit Corrected Sample Submission
- Obtain eCTD Identifier
- File actual submission in eCTD format
