Guidance on submitting pediatric development plans and pediatric studies: Annual reporting

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• Filing annual reports
• Annual reporting for foreign and Canadian PDPs

Filing annual reports

To help us track the progress of pediatric plans within the pilot, we ask that sponsors keep Health Canada up to date on the status of the studies identified in their pediatric development plans (PDPs) or Canadian pediatric development plans (C-PDPs). Sponsors are asked do so by submitting an annual report. Annual reports should not contain data generated during the reporting interval.

All annual reports should be filed through the Common Electronic Submissions Gateway (CESG) under the regulatory activity Pediatric Drug Plan – Annual Report (PDPAR) in the electronic common technical document (eCTD) format as follows:

Document type	eCTD module	eCTD document leaf title
Annual report for foreign-approved PDP	1.0.7 General note to reviewer	PDP annual report [date]
Annual report for C-PDP	1.0.7 General note to reviewer	C-PDP annual report [date]

For more information on how to file submissions electronically, consult:

• Preparation of drug regulatory activities in Electronic Common Technical Document (eCTD) format
• Filing submissions electronically

Sponsors should submit a single annual report for all open PDPs and C-PDPs on the anniversary date of the notice of compliance (NOC) for a drug with which the first pediatric plan was attached.

For example:

• a new drug submission (NDS) included a PDP and an NOC for the submission was issued on January 15, 2022
• a supplement to new drug submission (SNDS) filed later for the same product included another PDP, where an NOC for the SNDS was issued on October 23, 2024

In this example, sponsors would provide the annual reports for both PDPs together, as a single document, by the anniversary date of January 15.

Any changes to the PDP identified in an annual report will be noted by Health Canada. An approval letter will not be issued.

Substantial changes to pediatric plans should be submitted through the pediatric plan amendment process. For more information, refer to:

• Amending a foreign-approved PDP
• Amending an agreed-to Canadian PDP

Annual reporting for foreign and Canadian PDPs

Annual reports for both foreign-approved PDPs and agreed to C-PDPs should include:

• a note to reviewer containing:
  • identification of all current plans for the drug
  • identification of the expected plan completion date and subsequent study submission date for each current plan
    • update the expected plan completion date and subsequent study submission date based on any changes to study dates in the annual report
    • submit delays of more than 1 year as an amendment
• annual report document containing:
  • brief summaries of modifications made to each plan since the last annual report
  • reference to any approved amendments
  • indicate if Health Canada is currently reviewing any amendments
  • include other changes that did not qualify for a dedicated amendment submission
  • brief overview of the status of each of the planned nonclinical and clinical study detailed within the plan
    • format the overview as an updated tabular summary of planned nonclinical and clinical development

Sponsors should use a format similar to that in Table 2 when preparing annual reports.

Table 2. Recommended format for annual reports (entries are provided as examples only)

Section (include section of the iPSP/PIP and study ID if available)	Modification and rationale (if applicable) (include a brief summary of modification and rationale of why modification was necessary)	Completion date (include expected completion date based on agreed plan, agreed amendment or prior annual report) (include revised completion date if applicable)	Study status (include a brief status on whether the study is not yet started, is in progress (optional details as to which stage) or has been completed)
Nonclinical studies Study ABC	n/a	04/2022	Study completed
Request for drug-specific waiver and Planned pediatric clinical studies	Waiver for 0 to 2 age category added Phase II clinical study in patients aged 0 to 2 years removed Age-appropriate formulation not possible This change has also been submitted as an amendment (include amendment reference as appropriate)	n/a	n/a
Planned pediatric clinical studies Study XYZ	Enrollment changed from 150 to 100, with revised numbers per age groups as follows: 12 to 17 years – 50 patients 6 to 11 years – 40 patients 3 to 5 years – 10 patients It was not possible to reach enrollment goal (include 2- to 3-line explanation for why)	Expected completion date: 02/2023 Revised completion date: 06/2023	In progress
n/a: not applicable