2024-02-07 16:15:00
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About the pilot program
To support evidence-based pediatric treatments, it is essential to have information and data from clinical drug trials in children. Without this information, healthcare professionals must rely on other sources of clinical and scientific data to assess whether a drug’s benefits outweigh its risks for a particular patient.
Health Canada is taking steps to increase the accessibility of data that can help health professionals make these important decisions. One of these measures is to conduct a pilot program.
In the context of this pilot program, sponsors are encouraged to submit pediatric studies relating to drugs approved in Canada for use in adults. The pilot program begins February 26, 2024 and will last at least 2 years.
The pilot program applies to all New Drug Submissions (NDS) and Supplements to a New Drug Submission (SNDS) involving any of the changes listed below.
New indication New dosage form New route of administration
The policy underlying Health Canada’s Pediatric Development Plans and Pediatric Studies Pilot Program aligns with international approaches. Our objectives are:
Encourage sponsors to submit timely information on the safety and effectiveness of drugs expected to be used in pediatric populations Provide healthcare professionals, patients and their families with further information on the safety, effectiveness and dosage of medications used in pediatric populations Help guide future policies
Participation in the pilot program is voluntary and will not impact the outcome or duration of Health Canada’s review of your PDN or SPDN.
Sponsors wishing to take part in the pilot program should include a Pediatric Development Plan (PDP) in their submission package. Health Canada will thus be notified of their intention to take part in the pilot program.
Proponents whose submissions fall within the scope of the policy are also asked to complete a brief survey and attach it to their submission.
For more details on how to participate in the pilot program, please visit:
Additional information to consider
Interested parties provided comments regarding the draft guidelines during a 60-day consultation conducted from June 27 to August 26, 2023. Comments received during the consultation were incorporated into the guidelines where warranted.
Interested parties also had other comments and concerns, which are addressed in this section.
Transparency
Health Canada may use information from the Pediatric Drug Pilot Program survey to guide future policies. It may also publish a report on the main lessons learned from the pilot program. This report may include anonymized aggregate data, but no survey responses will be published.
PDPs presented during the pilot program will be subject to our transparency initiatives.
The following websites provide the results of regulatory reviews conducted by Health Canada, without direct mention of PDP:
The following websites may list PDPs presented during the pilot program:
During the pilot program, SDRs and SMDs might include statements regarding the existence of a PDP attached to the submission as well as the following elements regarding that PDP:
Whether it is based on an initial pediatric study plan (iPSP) or pediatric investigation plan (PIP) Whether it is a Canadian PDP Whether it contains justifications for not conducting studies in all or some pediatric populations
Consistent with current practices, the following website will continue to indicate pediatric data included in submissions:
Protection of pediatric data
Information generated during the PDP may be submitted through a supplement, in accordance with the Management of Drug Submissions and Applications guideline. The provisions of Food and Drug Regulations (FDR) regarding data protection continue to apply, and the pilot program has no impact on them.
To learn more regarding the provisions of the FDR and Patented Medicines (Notice of Compliance) Regulations regarding data protection, please see:
Impact on labeling requirements
The pilot program has no impact on current labeling requirements.
To learn more regarding labeling requirements, please see:
A PDP may include a rationale for not conducting studies in pediatric populations because conducting such studies would be unsafe or ineffective. In this case, Health Canada will determine which statements to include on the label based on the data presented, in accordance with current labeling requirements.
Canadian Addendum Format
Sponsors who participate in the pilot program by including an iPSP or PIP in their submission may clarify aspects of the foreign PDP for Health Canada. The following guideline provides examples of the type of information that may be included in the Canadian addendum:
The decision to include this additional information in the form of an addendum rests with the proponent. Since the content and format of the addendum may vary from one presentation to another, there is no template for the Canadian addendum.
Annual reports
Annual reports are an important aspect of the pilot program. They are intended to keep us informed of changes to plans that do not require submission of amendment requests.
The annual report should take the form of a short summary table. It should not contain data generated during the reporting period.
Health Canada will do this:
It will note any changes to a PDP indicated in an annual report It will not send an approval letter
Contact U.S
If you have any questions or comments regarding the pilot program, please email the Center for Policy, Pediatrics and International Collaboration at [email protected].
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