Regulatory Services: Submission Filing
A few key details to keep in mind prior to filing your submissions. Hear from our regulatory expert Anne Tomalin, Vice President, Quality, Regulatory and Safety as she reviews the required format for your submission, foreign reviews and whether submissions can be updated after filing.
The format for a new drug submission in Canada is the ICH format, the common technical document, and you are required to submit that as an eCTD, or an Electronic Common Technical Document. We follow ICH requirements for Modules 2, 3, 4, and 5. For Module 1, there is a very specific guideline that details what is required from a Canadian perspective in Module 1.
So clients frequently ask if a foreign review can be accepted in Canada. The answer is no. Health Canada does like to receive copies of foreign reviews, if they're available. However, Canada is an independent country, and Health Canada is required to make the decision about approval independently, and cannot simply accept an approval done by another country.
After a file has – a new drug submission has been filed in Canada you cannot update that file with the exception of safety. If a safety issue develops after the NDS has been filed, then you can update the submission. However, the safety issue has to be sufficient in degree that the product monograph is required to be updated. If you're not required to update the product monograph, then you cannot update the submission.