Consultation on draft guidance on submitting pediatric studies: Closed consultation

From: Health Canada

Current status: Closed

The consultation ran from June 27, 2023 to August 26, 2023.

About the consultation

Why we were consulting

The draft guidance document will help sponsors understand and interpret the proposed pediatric submission policy. The document was made available for a 60-day public consultation period.

The objectives of the pediatric submission policy are to:

  • encourage sponsors to submit 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

Input may also be used to help inform future policy direction on the potential development of pediatric regulations for Canada.

Who was the focus of this consultation

We invited input from scientific or technical stakeholders such as:

  • drug industry
  • academic communities
  • health system partners
  • consumer and patient safety organizations

Related information

Contact us

Centre for Policy, Pediatrics and International Collaboration
Biologic and Radiopharmaceutical Drugs Directorate
Health Products and Food Branch
Health Canada

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