Pediatric pilot survey
Health Canada is currently undertaking a pilot regarding the submission of pediatric development plans and pediatric studies. For details about the pilot and how to participate, please consult:
Participation in the pilot is voluntary. However, we ask all sponsors who file a submission within the scope of the pilot to complete the following survey:
The following submissions are within the scope of the pilot:
- new drug submission (NDS)
- supplementary new drug submission (SNDS) that includes 1 of the following changes:
- new indication
- new dosage form
- new route of administration
Sponsors filing submissions within the scope of the pilot should submit the survey in the electronic common technical document (eCTD) format as follows:
| Document type | eCTD module | eCTD document leaf title |
|---|---|---|
| Survey | 1.0.7 General note to reviewer | Survey |
Your responses may be used to inform future policy.
Your responses to the survey and decision to participate in the pilot will not affect the review of your submission.
For questions about this survey or pilot, please contact:
Biologic and Radiopharmaceutical Drugs Directorate (BRDD)
Centre for Policy, Pediatrics and International Collaboration
Health Products and Food Branch
Health Canada
Email: brdd-cppic_brdd-cppci@hc-sc.gc.ca
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