Guidance on submitting pediatric development plans and pediatric studies: Study reports
To align with regulatory reviews of pediatric data in other jurisdictions, sponsors are asked to submit their pediatric studies according to the timelines identified in the letter issued at the time of the notice of compliance (NOC). If the timelines have been modified through subsequent filings, Health Canada requests that sponsors submit their completed pediatric study reports according to the timelines identified in their most recent annual report.
Sponsors submitting final reports should file a supplement to a new drug submission (SNDS) according to the procedures outlined in the following guidance document: