Pilot on pediatric development plans and studies
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About the pilot
Information and data from clinical trials of drugs in children are essential to support evidence-based pediatric therapies. Without this information, health care providers rely on other sources of clinical and scientific evidence to assess if a drug's benefits outweigh its risks for a specific patient.
Health Canada is taking steps to increase the availability of data that will help health care providers make these important decisions. One of these steps is to conduct a pilot program.
The pilot encourages sponsors to submit pediatric studies for drugs approved for adults in Canada. It starts on February 26, 2024, and will run for at least 2 years.
The pilot applies to all new drug submissions (NDS) and supplements to a new drug submission (SNDS) for any:
- new indication
- new dosage form
- new route of administration
The policy behind Health Canada's pediatric development plan and study pilot aligns with international approaches. Our objectives are to:
- encourage sponsors to submit, in a timely manner, safety and efficacy information for drugs expected to be used in pediatric populations
- provide more information on the safety, efficacy and dosage of drugs used in pediatric populations to health care providers, patients and their families
- help to inform future policy
Participation in the pilot is voluntary and will not affect the outcome or timeline of our review of your NDS or SNDS.
Sponsors who wish to participate in the pilot should include a pediatric development plan (PDP) with their submission. This will notify us that you intend to participate in the pilot.
We're also asking those whose submissions are within the scope of the policy to fill out a short survey and include it with your submission:
For further details on how to participate in the pilot, please refer to the following guidance document:
Additional information for consideration
Stakeholders commented on the draft guidance document during a 60-day consultation, which took place from June 27 to August 26, 2023. Comments received during the consultation are reflected in the guidance document, as appropriate.
Stakeholders also had additional comments or concerns, which we address in this section.
Health Canada may use information obtained from the pediatric pilot survey to inform future policy. We may also publish a report of the key take-aways from the pilot. This report may include anonymized aggregated data but no individual survey responses will be made public.
PDPs submitted during the pilot will be subject to our transparency initiatives.
The following websites report the outcome of Health Canada's regulatory review, but will not contain a direct reference to PDPs:
The following websites may refer to PDPs submitted during the pilot:
During the pilot, statements may be included in the RDS and SBD about a submission having a PDP and whether the PDP:
- was based on an existing iPSP, PIP
- was a C-PDP
- contained rationales for not conducting studies in all or part of the pediatric population
The following website will continue to reflect pediatric data filed for the submission in keeping with current practice:
Pediatric data protection
Information generated during the course of the PDP may be submitted through a supplement and in accordance with the Management of Drug Submissions and Applications guidance. The data protection provisions of the Food and Drugs Regulations (FDR) continue to apply and are not affected by the pilot.
For information on the data protection provisions of the FDR or the Patented Medicines (Notice of Compliance) Regulations, consult the following guidance documents:
- Data protection under C.08.004.1 of the Food and Drug Regulations
- Patented Medicines (Notice of Compliance) Regulations
Impact on labelling requirements
The pilot does not affect existing labelling requirements.
For information on labelling requirements, consult the following guidance documents:
A PDP may include a rationale for not conducting studies in pediatric population(s) because the studies would be unsafe or ineffective. In this case, Health Canada will determine the appropriate labelling statements based on the data submitted in accordance with the existing labelling requirements.
Format for the Canadian addendum
Sponsors who participate in the pilot by including an iPSP or PIP with their submission may clarify aspects of the foreign pediatric plan to Health Canada. Examples of the type of information that could be provided in the addendum are included in the following guidance document:
The decision to include this additional information in the form of an addendum is up to the sponsor. As the content and format can vary based on individual submissions, there is no template for the addendum.
Annual reports are an important aspect of the pilot. They are intended to keep us informed of changes to the plans that are outside of the scope of amendment submissions.
The annual report should be in the form of a brief summary table. It should not contain any data generated during the reporting period.
- note any changes to the PDP identified in an annual report
- not issue an approval letter
If you have questions or comments about the pilot, please contact the Centre for Policy, Pediatrics and International Collaboration by email: firstname.lastname@example.org.
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