Guidance on submitting pediatric development plans and pediatric studies: Plans with subsequent SNDSs

Products with existing pediatric development plans (PDPs) or Canadian PDPs (C-PDPs) may undergo subsequent supplement to new drug submission (SNDS) filings. These may require either updates to the existing PDP/C-PDP document or addition of new PDPs/C-PDPs to the drug file.

If the existing plan is suitable for the proposed SNDS, the sponsor may notify Health Canada that no update to the plan is required in the note to reviewer.

If an existing plan can be updated to accommodate the proposed changes(s) in the SNDS, the sponsor may modify the existing plan and include it with the SNDS.

If the changes being sought in the SNDS require a different plan, then the sponsor may submit a new plan. The new plan will be added to the drug file, with the existing PDP(s) or C-PDP(s).

When providing an updated plan or filing a new plan, the sponsor must follow the applicable pediatric plan filing procedures outlined in this guidance.

Health Canada will assess the updated or new PDP or C-PDP according to the procedures for a foreign-approved PDP or an agreed-to C-PDP (as applicable).

Sponsors should submit a single annual report for all open PDPs on the anniversary date of the notice of compliance (NOC) for the submission containing the first pediatric plan.

For more information, refer to the Annual reporting page of this guidance.